Trial Outcomes & Findings for A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack (NCT NCT03487445)
NCT ID: NCT03487445
Last Updated: 2025-07-09
Results Overview
The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using the VerifyNow® assay. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU).The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU less than 100 at 30 minutes post-dose was counted as a participant that had a pharmacodynamic response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
30 minutes after the administration of the subcutaneous injection
Results posted on
2025-07-09
Participant Flow
The study was conducted between 10 July and 10 November 2018. Seven sites were initiated. Six sites in 3 countries screened and randomized 48 participants.
Forty-eight patients were randomized to either selatogrel 8 mg or 16 mg. Forty-seven patients were administered selatogrel and completed the study. One patient randomized to the 8 mg group did not receive selatogrel (not treated for administrative reasons) and was excluded from the full-analysis set (FAS).
Participant milestones
| Measure |
Selatogrel 8 mg
A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
Selatogrel 16 mg
A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
|---|---|---|
|
Randomization
STARTED
|
25
|
23
|
|
Randomization
COMPLETED
|
24
|
23
|
|
Randomization
NOT COMPLETED
|
1
|
0
|
|
Treatment Period
STARTED
|
24
|
23
|
|
Treatment Period
Modified Full Analysis Set (mFAS)
|
23
|
22
|
|
Treatment Period
Per Protocol Set
|
20
|
20
|
|
Treatment Period
COMPLETED
|
24
|
23
|
|
Treatment Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Selatogrel 8 mg
A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
Selatogrel 16 mg
A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
|---|---|---|
|
Randomization
Not treated for administrative reasons
|
1
|
0
|
Baseline Characteristics
The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
Baseline characteristics by cohort
| Measure |
Selatogrel 8 mg
n=24 Participants
A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
Selatogrel 16 mg
n=23 Participants
A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Full Analysis Set · <=18 years
|
0 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Age, Categorical
Full Analysis Set · Between 18 and 65 years
|
9 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
8 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
17 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Age, Categorical
Full Analysis Set · >=65 years
|
15 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
15 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
30 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Age, Categorical
Per Protocol Set · <=18 years
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Age, Categorical
Per Protocol Set · Between 18 and 65 years
|
9 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
7 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
16 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Age, Categorical
Per Protocol Set · >=65 years
|
11 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
13 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
24 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Age, Continuous
Full Analysis Set
|
65.5 years
STANDARD_DEVIATION 11.3 • n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
68.0 years
STANDARD_DEVIATION 10.3 • n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
66.7 years
STANDARD_DEVIATION 10.8 • n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Age, Continuous
Per Protocol Set
|
64.5 years
STANDARD_DEVIATION 12.1 • n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
67.9 years
STANDARD_DEVIATION 10.3 • n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
66.2 years
STANDARD_DEVIATION 11.3 • n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Sex: Female, Male
Full Analysis Set · Female
|
8 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
5 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
13 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Sex: Female, Male
Full Analysis Set · Male
|
16 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
18 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
34 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Sex: Female, Male
Per Protocol Set · Female
|
5 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
4 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
9 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Sex: Female, Male
Per Protocol Set · Male
|
15 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
16 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
31 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Ethnicity (NIH/OMB)
Full Analysis Set · Hispanic or Latino
|
0 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Ethnicity (NIH/OMB)
Full Analysis Set · Not Hispanic or Latino
|
24 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
23 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
47 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Ethnicity (NIH/OMB)
Full Analysis Set · Unknown or Not Reported
|
0 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Ethnicity (NIH/OMB)
Per Protocol Set · Hispanic or Latino
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Ethnicity (NIH/OMB)
Per Protocol Set · Not Hispanic or Latino
|
20 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
20 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
40 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Ethnicity (NIH/OMB)
Per Protocol Set · Unknown or Not Reported
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Race (NIH/OMB)
Full Analysis Set · American Indian or Alaska Native
|
0 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Race (NIH/OMB)
Full Analysis Set · Asian
|
1 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
2 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
3 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Race (NIH/OMB)
Full Analysis Set · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Race (NIH/OMB)
Full Analysis Set · Black or African American
|
0 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Race (NIH/OMB)
Full Analysis Set · White
|
22 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
21 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
43 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Race (NIH/OMB)
Full Analysis Set · More than one race
|
0 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Race (NIH/OMB)
Full Analysis Set · Unknown or Not Reported
|
1 Participants
n=24 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=23 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
1 Participants
n=47 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Race (NIH/OMB)
Per Protocol Set · American Indian or Alaska Native
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Race (NIH/OMB)
Per Protocol Set · Asian
|
1 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
2 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
3 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Race (NIH/OMB)
Per Protocol Set · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Race (NIH/OMB)
Per Protocol Set · Black or African American
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Race (NIH/OMB)
Per Protocol Set · White
|
18 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
18 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
36 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Race (NIH/OMB)
Per Protocol Set · More than one race
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Race (NIH/OMB)
Per Protocol Set · Unknown or Not Reported
|
1 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
0 Participants
n=20 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
1 Participants
n=40 Participants • The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).
|
|
Region of Enrollment
Belgium
|
7 participants
n=24 Participants
|
7 participants
n=23 Participants
|
14 participants
n=47 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=24 Participants
|
0 participants
n=23 Participants
|
1 participants
n=47 Participants
|
|
Region of Enrollment
Switzerland
|
16 participants
n=24 Participants
|
16 participants
n=23 Participants
|
32 participants
n=47 Participants
|
|
Body Mass Index
Full Analysis Set
|
28.00 kilograms per square meter
STANDARD_DEVIATION 4.83 • n=24 Participants
|
26.78 kilograms per square meter
STANDARD_DEVIATION 3.74 • n=23 Participants
|
27.40 kilograms per square meter
STANDARD_DEVIATION 4.33 • n=47 Participants
|
|
Body Mass Index
Per Protocol Set
|
27.64 kilograms per square meter
STANDARD_DEVIATION 4.88 • n=24 Participants
|
26.67 kilograms per square meter
STANDARD_DEVIATION 3.79 • n=23 Participants
|
27.16 kilograms per square meter
STANDARD_DEVIATION 4.34 • n=47 Participants
|
|
Medical history risk factors at baseline
Diabetes mellitus
|
8 Participants
n=24 Participants
|
5 Participants
n=23 Participants
|
13 Participants
n=47 Participants
|
|
Medical history risk factors at baseline
Chronic Kidney disease
|
0 Participants
n=24 Participants
|
3 Participants
n=23 Participants
|
3 Participants
n=47 Participants
|
|
Medical history risk factors at baseline
Hypertension
|
15 Participants
n=24 Participants
|
12 Participants
n=23 Participants
|
27 Participants
n=47 Participants
|
|
Medical history risk factors at baseline
Dyslipidemia
|
8 Participants
n=24 Participants
|
10 Participants
n=23 Participants
|
18 Participants
n=47 Participants
|
|
Diagnosis at enrollment
NSTEMI
|
8 Participants
n=24 Participants
|
10 Participants
n=23 Participants
|
18 Participants
n=47 Participants
|
|
Diagnosis at enrollment
STEMI
|
16 Participants
n=24 Participants
|
13 Participants
n=23 Participants
|
29 Participants
n=47 Participants
|
|
STEMI: Thrombolysis in myocardial infarction (TIMI) risk score
STEMI : TIMI Risk Score less than 3
|
9 Participants
n=16 Participants • Participants diagnosis at enrollment with STEMI (ST-segment elevation myocardial infarction)
|
6 Participants
n=13 Participants • Participants diagnosis at enrollment with STEMI (ST-segment elevation myocardial infarction)
|
15 Participants
n=29 Participants • Participants diagnosis at enrollment with STEMI (ST-segment elevation myocardial infarction)
|
|
STEMI: Thrombolysis in myocardial infarction (TIMI) risk score
STEMI : TIMI Risk Score 3 or greater
|
7 Participants
n=16 Participants • Participants diagnosis at enrollment with STEMI (ST-segment elevation myocardial infarction)
|
7 Participants
n=13 Participants • Participants diagnosis at enrollment with STEMI (ST-segment elevation myocardial infarction)
|
14 Participants
n=29 Participants • Participants diagnosis at enrollment with STEMI (ST-segment elevation myocardial infarction)
|
|
NSTEMI: Thrombolysis in myocardial infarction (TIMI) risk score
NSTEMI: TIMI risk score less than 5
|
6 Participants
n=8 Participants • Participants diagnosis at enrollment with NSTEMI (Non-ST-segment elevation myocardial infarction)
|
6 Participants
n=10 Participants • Participants diagnosis at enrollment with NSTEMI (Non-ST-segment elevation myocardial infarction)
|
12 Participants
n=18 Participants • Participants diagnosis at enrollment with NSTEMI (Non-ST-segment elevation myocardial infarction)
|
|
NSTEMI: Thrombolysis in myocardial infarction (TIMI) risk score
NSTEMI: TIMI risk score 5 and above
|
2 Participants
n=8 Participants • Participants diagnosis at enrollment with NSTEMI (Non-ST-segment elevation myocardial infarction)
|
4 Participants
n=10 Participants • Participants diagnosis at enrollment with NSTEMI (Non-ST-segment elevation myocardial infarction)
|
6 Participants
n=18 Participants • Participants diagnosis at enrollment with NSTEMI (Non-ST-segment elevation myocardial infarction)
|
|
Time from onset of acute myocardial infarction symptoms to treatment start
|
4.00 hours
STANDARD_DEVIATION 1.64 • n=24 Participants
|
3.85 hours
STANDARD_DEVIATION 1.56 • n=23 Participants
|
3.93 hours
STANDARD_DEVIATION 1.59 • n=47 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after the administration of the subcutaneous injectionPopulation: The modified full analysis set (mFAS) includes all participants from the FAS who have an assessment of the primary endpoint (that is all participants with a 30-min post dose VerifyNow® blood sample analysis).
The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using the VerifyNow® assay. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU).The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU less than 100 at 30 minutes post-dose was counted as a participant that had a pharmacodynamic response.
Outcome measures
| Measure |
Selatogrel 8 mg
n=23 Participants
A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
Selatogrel 16 mg
n=22 Participants
A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
|---|---|---|
|
Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
|
21 Count of participants
|
21 Count of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 minutes after the administration of the subcutaneous injectionPopulation: Supportive analysis of the primary endpoint: per-protocol set
The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU of less than 100 starting at 30 minutes post-dose was counted as a participant that had a pharmacodynamic response.
Outcome measures
| Measure |
Selatogrel 8 mg
n=20 Participants
A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
Selatogrel 16 mg
n=20 Participants
A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
|---|---|---|
|
Number of Participants (Per-protocol Subgroup) With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
|
18 Count of participants
|
19 Count of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-dose, 15, 30 and 60 minutes after the administration of the subcutaneous injectionPopulation: Full analysis set
The purpose of this supportive analysis was to assess the effect when relaxing the time of a PRU \< 100, i.e., considering as a response a PRU \< 100 at 15, 30 or 60 min. post injection. The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using the VerifyNow® assay. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU).The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU less than 100 post-dose was counted as a participant that had a pharmacodynamic response.
Outcome measures
| Measure |
Selatogrel 8 mg
n=24 Participants
A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
Selatogrel 16 mg
n=23 Participants
A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
|---|---|---|
|
Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation
pre-dose
|
1 Count of participants
|
0 Count of participants
|
|
Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation
15 minutes post-dose
|
18 Count of participants
|
21 Count of participants
|
|
Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation
30 minutes post-dose
|
21 Count of participants
|
21 Count of participants
|
|
Number of Participants With a Pharmacodynamic Response Within the First Hour as Assessed by the Inhibition of Platelet Aggregation
60 minutes post-dose
|
18 Count of participants
|
22 Count of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-dose, 15, 30 and 60 minutes after administration of the subcutaneous injectionPopulation: Full Analysis Set
The pharmacodynamic response assessed by the inhibition of adenosine diphosphate (ADP)-mediated platelet aggregation was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test. The results are expressed as P2Y12 reaction units (PRU).
Outcome measures
| Measure |
Selatogrel 8 mg
n=24 Participants
A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
Selatogrel 16 mg
n=23 Participants
A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
|---|---|---|
|
Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time
pre-dose
|
194 P2Y12 reaction units (PRU)
Interval 159.0 to 213.0
|
181 P2Y12 reaction units (PRU)
Interval 148.0 to 213.0
|
|
Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time
15 minutes post-dose
|
51 P2Y12 reaction units (PRU)
Interval 4.0 to 208.0
|
9 P2Y12 reaction units (PRU)
Interval 2.0 to 282.0
|
|
Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time
30 minutes post-dose
|
59 P2Y12 reaction units (PRU)
Interval 2.0 to 135.0
|
9 P2Y12 reaction units (PRU)
Interval 2.0 to 117.0
|
|
Absolute Platelet Reactivity (P2Y12 Reaction Units) Over Time
60 minutes post-dose
|
9 P2Y12 reaction units (PRU)
Interval 2.0 to 116.0
|
7 P2Y12 reaction units (PRU)
Interval 1.0 to 228.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-dose, 15, 30 and 60 minutes and 8 hours after the administration of the subcutaneous injectionPopulation: Pharmacokinetic analysis set - all participants that had at least one selatogrel concentration measurement after administration of study treatment.
The Cmax is the peak concentration of selatogrel in the plasma after subcutaneous injection. The pharmacokinetic parameters of selatogrel (ACT-246475) were derived by non-compartmental analyses of the plasma concentration-time profiles.
Outcome measures
| Measure |
Selatogrel 8 mg
n=24 Participants
A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
Selatogrel 16 mg
n=22 Participants
A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
|---|---|---|
|
Maximum Selatogrel Plasma Concentration (Cmax)
|
390.1 ng/mL
Interval 206.0 to 848.0
|
672.6 ng/mL
Interval 276.0 to 1180.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-dose, 15, 30 and 60 minutes and 8 hours after the administration of the subcutaneous injectionPopulation: Pharmacokinetic analysis set - all participants that had at least one selatogrel concentration measurement after administration of study treatment.
Time after subcutaneous injection to reach the maximum observed selatogrel plasma concentration (Cmax).
Outcome measures
| Measure |
Selatogrel 8 mg
n=24 Participants
A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
Selatogrel 16 mg
n=22 Participants
A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
|---|---|---|
|
Time to Reach Maximum Selatogrel Plasma Concentration (Tmax)
|
1.00 hours
Interval 0.5 to 1.27
|
0.97 hours
Interval 0.25 to 1.15
|
POST_HOC outcome
Timeframe: 30 minutes after the administration of the subcutaneous injectionPopulation: Full Analysis Set
The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU of less than 100 starting at 30 minutes post-dose was counted as a participant that had a pharmacodynamic response.
Outcome measures
| Measure |
Selatogrel 8 mg
n=24 Participants
A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
Selatogrel 16 mg
n=23 Participants
A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
|---|---|---|
|
Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
Age less than 55 years old
|
3 Count of participants
|
4 Count of participants
|
|
Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
Age 55 years and older
|
18 Count of participants
|
17 Count of participants
|
|
Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
Male
|
14 Count of participants
|
17 Count of participants
|
|
Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
Female
|
7 Count of participants
|
4 Count of participants
|
|
Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
Body Mass Index less than 25
|
5 Count of participants
|
8 Count of participants
|
|
Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
Body Mass Index less than 25 and up to 30
|
8 Count of participants
|
9 Count of participants
|
|
Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
Body Mass Index greater than 30
|
8 Count of participants
|
4 Count of participants
|
|
Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
Diabetes mellitus at baseline
|
8 Count of participants
|
5 Count of participants
|
|
Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
No diabetes mellitus at baseline
|
13 Count of participants
|
16 Count of participants
|
|
Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
Chronic kidney disease at baseline
|
—
|
3 Count of participants
|
|
Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
No Chronic kidney disease at baseline
|
21 Count of participants
|
18 Count of participants
|
|
Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
STEMI at baseline
|
14 Count of participants
|
11 Count of participants
|
|
Subgroup Analyses: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation
NSTEMI at baseline
|
7 Count of participants
|
10 Count of participants
|
Adverse Events
Selatogrel 8 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Selatogrel 16 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Selatogrel 8 mg
n=24 participants at risk
A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
Selatogrel 16 mg
n=23 participants at risk
A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
|---|---|---|
|
Cardiac disorders
Ventricular tachycardia
|
4.2%
1/24 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
4.3%
1/23 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
Other adverse events
| Measure |
Selatogrel 8 mg
n=24 participants at risk
A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
Selatogrel 16 mg
n=23 participants at risk
A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous injection in the thigh.
|
|---|---|---|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/24 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
4.3%
1/23 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Vascular disorders
Arteriovenous fistula
|
4.2%
1/24 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
0.00%
0/23 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Vascular disorders
Hypertension
|
4.2%
1/24 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
0.00%
0/23 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Vascular disorders
Hypotension
|
4.2%
1/24 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
0.00%
0/23 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
4.2%
1/24 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
0.00%
0/23 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Vascular disorders
Vascular pseudoaneurysm
|
4.2%
1/24 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
0.00%
0/23 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Cardiac disorders
Atrial fibrillation
|
4.2%
1/24 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
0.00%
0/23 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/24 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
4.3%
1/23 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Cardiac disorders
Extrasystoles
|
4.2%
1/24 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
0.00%
0/23 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/24 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
4.3%
1/23 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Cardiac disorders
Nodal rhythm
|
4.2%
1/24 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
0.00%
0/23 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Cardiac disorders
Ventricular tachycardia
|
12.5%
3/24 • Number of events 3 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
8.7%
2/23 • Number of events 2 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/24 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
4.3%
1/23 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/24 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
4.3%
1/23 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Immune system disorders
Hypersensitivity
|
4.2%
1/24 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
0.00%
0/23 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
4.3%
1/23 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
0.00%
0/23 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Psychiatric disorders
Agitation
|
4.2%
1/24 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
0.00%
0/23 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/24 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
4.3%
1/23 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Psychiatric disorders
Delirium
|
4.2%
1/24 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
0.00%
0/23 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
12.5%
3/24 • Number of events 3 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
8.7%
2/23 • Number of events 2 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.2%
1/24 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
0.00%
0/23 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/24 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
4.3%
1/23 • Number of events 1 • Treatment emergent adverse events (TEAEs) were those adverse events with onset after study drug administration and up to 48 hours after study treatment administration.
|
Additional Information
Viatris Innovation Clinical Trial Information
Viatris Innovation GmbH
Phone: +41 58 844 07 44
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place