Trial Outcomes & Findings for Switching From Ticagrelor to Clopidogrel in Patients With Coronary Artery Disease (NCT NCT02287909)
NCT ID: NCT02287909
Last Updated: 2020-09-16
Results Overview
PRU assessed by VerifyNow at 48 hours after switching of clopidogrel 600 mg LD administered 24 hours after the last ticagrelor MD vs. clopidogrel 75 mg MD given 24 hours after the last ticagrelor MD
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
87 participants
Primary outcome timeframe
48 hours after switch
Results posted on
2020-09-16
Participant Flow
87 patients entered a run-in phase. Of these, 7 withdrew during run in.
Participant milestones
| Measure |
A) Clopidogrel 600 mg LD 24 Hours After Last MD of Ticagrelor
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Clopidogrel: Swiching from ticagrelor to clopidogrel
|
B) Clopidogrel 600 mg LD 12 Hours After Last MD of Ticagrelor
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Clopidogrel: Swiching from ticagrelor to clopidogrel
|
C) Clopidogrel 75mg MD 24 Hours After Last MD of Ticagrelor
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Clopidogrel: Swiching from ticagrelor to clopidogrel
|
D) Continue Ticagrelor MD 90mg Twice Daily
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Ticagrelor: Continue treatment with ticagrelor
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
information for each of the 4 groups and overall provided and mean and SD
Baseline characteristics by cohort
| Measure |
A) Clopidogrel 600 mg LD 24 Hours After Last MD of Ticagrelor
n=20 Participants
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Clopidogrel: Swiching from ticagrelor to clopidogrel
|
B) Clopidogrel 600 mg LD 12 Hours After Last MD of Ticagrelor
n=20 Participants
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Clopidogrel: Swiching from ticagrelor to clopidogrel
|
C) Clopidogrel 75mg MD 24 Hours After Last MD of Ticagrelor
n=20 Participants
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Clopidogrel: Swiching from ticagrelor to clopidogrel
|
D) Continue Ticagrelor MD 90mg Twice Daily
n=20 Participants
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Ticagrelor: Continue treatment with ticagrelor
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 7 • n=5 Participants • information for each of the 4 groups and overall provided and mean and SD
|
65 years
STANDARD_DEVIATION 8 • n=7 Participants • information for each of the 4 groups and overall provided and mean and SD
|
63 years
STANDARD_DEVIATION 9 • n=5 Participants • information for each of the 4 groups and overall provided and mean and SD
|
58 years
STANDARD_DEVIATION 9 • n=4 Participants • information for each of the 4 groups and overall provided and mean and SD
|
62 years
STANDARD_DEVIATION 8 • n=21 Participants • information for each of the 4 groups and overall provided and mean and SD
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
20 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 48 hours after switchPRU assessed by VerifyNow at 48 hours after switching of clopidogrel 600 mg LD administered 24 hours after the last ticagrelor MD vs. clopidogrel 75 mg MD given 24 hours after the last ticagrelor MD
Outcome measures
| Measure |
A) Clopidogrel 600 mg LD 24 Hours After Last MD of Ticagrelor
n=18 Participants
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Clopidogrel: Swiching from ticagrelor to clopidogrel
|
B) Clopidogrel 600 mg LD 12 Hours After Last MD of Ticagrelor
n=19 Participants
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Clopidogrel: Swiching from ticagrelor to clopidogrel
|
C) Clopidogrel 75mg MD 24 Hours After Last MD of Ticagrelor
n=20 Participants
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Clopidogrel: Swiching from ticagrelor to clopidogrel
|
D) Continue Ticagrelor MD 90mg Twice Daily
n=19 Participants
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Ticagrelor: Continue treatment with ticagrelor
|
|---|---|---|---|---|
|
Platelet Reactivity Unit
|
177 PRU
Standard Error 27
|
164 PRU
Standard Error 24
|
174 PRU
Standard Error 24
|
26 PRU
Standard Error 25
|
Adverse Events
A) Clopidogrel 600 mg LD 24 Hours After Last MD of Ticagrelor
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
B) Clopidogrel 600 mg LD 12 Hours After Last MD of Ticagrelor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
C) Clopidogrel 75mg MD 24 Hours After Last MD of Ticagrelor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
D) Continue Ticagrelor MD 90mg Twice Daily
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A) Clopidogrel 600 mg LD 24 Hours After Last MD of Ticagrelor
n=20 participants at risk
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Clopidogrel: Swiching from ticagrelor to clopidogrel
|
B) Clopidogrel 600 mg LD 12 Hours After Last MD of Ticagrelor
n=20 participants at risk
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Clopidogrel: Swiching from ticagrelor to clopidogrel
|
C) Clopidogrel 75mg MD 24 Hours After Last MD of Ticagrelor
n=20 participants at risk
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Clopidogrel: Swiching from ticagrelor to clopidogrel
|
D) Continue Ticagrelor MD 90mg Twice Daily
n=20 participants at risk
Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily
Ticagrelor: Continue treatment with ticagrelor
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dypnea
|
5.0%
1/20 • Number of events 1 • 10 days
|
0.00%
0/20 • 10 days
|
0.00%
0/20 • 10 days
|
5.0%
1/20 • Number of events 1 • 10 days
|
|
Vascular disorders
Bleeding
|
0.00%
0/20 • 10 days
|
0.00%
0/20 • 10 days
|
0.00%
0/20 • 10 days
|
5.0%
1/20 • Number of events 1 • 10 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place