Trial Outcomes & Findings for Cangrelor Prasugrel Transition Study (NCT NCT01852019)
NCT ID: NCT01852019
Last Updated: 2015-06-24
Results Overview
A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence or absence of the study drugs was examined for each of the endpoints using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.
Results posted on
2015-06-24
Participant Flow
Participant milestones
| Measure |
Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion
Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation
cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h
Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time.
cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h
Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time.
cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 8 - Prasugrel (10mg) Dosing (5 Doses)
Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h)
cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 8 - Prasugrel (10mg) Dosing (6 Doses)
Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)
cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
|---|---|---|---|---|---|
|
Day 1
STARTED
|
3
|
3
|
6
|
0
|
0
|
|
Day 1
COMPLETED
|
3
|
3
|
6
|
0
|
0
|
|
Day 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Day 8
STARTED
|
0
|
0
|
0
|
6
|
6
|
|
Day 8
COMPLETED
|
0
|
0
|
0
|
6
|
6
|
|
Day 8
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cangrelor Prasugrel Transition Study
Baseline characteristics by cohort
| Measure |
Day 8 - Prasugrel (10mg) Dosing (6 Doses)
n=6 Participants
Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)
Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 8 - Prasugrel (10mg) Dosing (5 Doses)
n=6 Participants
Prasugrel discontinued 48h prior to initiation of cangrelor infusion (2h)
Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 6.47 • n=5 Participants
|
67.3 years
STANDARD_DEVIATION 4.37 • n=7 Participants
|
64.8 years
STANDARD_DEVIATION 5.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.Population: Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.
A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence or absence of the study drugs was examined for each of the endpoints using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).
Outcome measures
| Measure |
Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h)
n=3 Participants
Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h
n=6 Participants
Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h
n=3 Participants
Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
|---|---|---|---|
|
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
Prasugrel Reference (6.0h or 5.5 h)
|
1.0 % aggregation
Standard Deviation 1.0
|
2.8 % aggregation
Standard Deviation 3.1
|
5.0 % aggregation
Standard Deviation 6.2
|
|
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
2.25 h
|
27 % aggregation
Standard Deviation 20
|
25 % aggregation
Standard Deviation 15
|
45 % aggregation
Standard Deviation 24
|
|
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
2.5 h
|
56 % aggregation
Standard Deviation 6.7
|
42 % aggregation
Standard Deviation 27
|
62 % aggregation
Standard Deviation 3.8
|
|
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
2.75 h
|
64 % aggregation
Standard Deviation 2.1
|
31 % aggregation
Standard Deviation 33
|
69 % aggregation
Standard Deviation 4.6
|
|
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
3.0 h
|
58 % aggregation
Standard Deviation 14
|
24 % aggregation
Standard Deviation 26
|
51 % aggregation
Standard Deviation 5.1
|
|
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
4.0 h
|
1.0 % aggregation
Standard Deviation 1.7
|
10 % aggregation
Standard Deviation 15
|
15 % aggregation
Standard Deviation 18
|
PRIMARY outcome
Timeframe: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusionPopulation: Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.
A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 μM adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).
Outcome measures
| Measure |
Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h)
n=6 Participants
Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h
n=6 Participants
Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h
Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
|---|---|---|---|
|
Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone
1.0 h
|
0.5 % aggregation
Standard Deviation 0.8
|
1.3 % aggregation
Standard Deviation 2.0
|
—
|
|
Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone
2.0 h
|
0.0 % aggregation
Standard Deviation 0.0
|
1.0 % aggregation
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.Population: Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.
A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence of absence of the study drugs was examined for each of the endpoints as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.
Outcome measures
| Measure |
Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h)
n=3 Participants
Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h
n=6 Participants
Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h
n=3 Participants
Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
|---|---|---|---|
|
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
Prasugrel Reference (6.0h or 5.5h) - PRU
|
7.7 platelet reaction units (PRU)
Standard Deviation 12
|
41 platelet reaction units (PRU)
Standard Deviation 42
|
74 platelet reaction units (PRU)
Standard Deviation 60
|
|
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
2.25h - PRU
|
91 platelet reaction units (PRU)
Standard Deviation 82
|
82 platelet reaction units (PRU)
Standard Deviation 39
|
151 platelet reaction units (PRU)
Standard Deviation 77
|
|
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
2.5h - PRU
|
242 platelet reaction units (PRU)
Standard Deviation 50
|
181 platelet reaction units (PRU)
Standard Deviation 70
|
269 platelet reaction units (PRU)
Standard Deviation 38
|
|
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
2.75h - PRU
|
267 platelet reaction units (PRU)
Standard Deviation 25
|
134 platelet reaction units (PRU)
Standard Deviation 94
|
285 platelet reaction units (PRU)
Standard Deviation 35
|
|
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
3.0h - PRU
|
239 platelet reaction units (PRU)
Standard Deviation 50
|
127 platelet reaction units (PRU)
Standard Deviation 124
|
242 platelet reaction units (PRU)
Standard Deviation 32
|
|
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
4.0h - PRU
|
20 platelet reaction units (PRU)
Standard Deviation 31
|
56 platelet reaction units (PRU)
Standard Deviation 68
|
117 platelet reaction units (PRU)
Standard Deviation 77
|
SECONDARY outcome
Timeframe: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusionPopulation: Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.
A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.
Outcome measures
| Measure |
Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h)
n=6 Participants
Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h
n=6 Participants
Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h
Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
|---|---|---|---|
|
Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone
1.0 h - PRU
|
6.3 platelet reaction units (PRU)
Standard Deviation 6.6
|
8.3 platelet reaction units (PRU)
Standard Deviation 5.4
|
—
|
|
Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone
2.0 h - PRU
|
4.7 platelet reaction units (PRU)
Standard Deviation 2.6
|
13 platelet reaction units (PRU)
Standard Deviation 18
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 8Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Days 1 and 8. Reports of bleeding were to be evaluated by performance of a CBC. Bleeding was to be reported as recommended and quantified in accordance with the GUSTO criteria \[The GUSTO Investigators, 1993\].
Outcome measures
| Measure |
Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h)
n=6 Participants
Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h
n=6 Participants
Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h
Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
|
|---|---|---|---|
|
Bleeding Events in Accordance With the GUSTO Scale
Mild
|
1 participants
|
0 participants
|
—
|
|
Bleeding Events in Accordance With the GUSTO Scale
Moderate
|
0 participants
|
0 participants
|
—
|
|
Bleeding Events in Accordance With the GUSTO Scale
Life-threatening/Severe
|
0 participants
|
0 participants
|
—
|
Adverse Events
Day 1 - Prasugrel (60mg) at 1.5 Hrs
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Day 1 - Prasugrel (60mg) at 1.0 hr
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Day 1 - Prasugrel (60mg) - Post Infusion (2.0 hr)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Day 8 - Prasugrel (10mg) Dosing (6 Doses)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Day 8 - Prasugrel (10mg) Dosing (5 Doses)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Day 1 - Prasugrel (60mg) at 1.5 Hrs
n=6 participants at risk
Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.5 hours after infusion start).
|
Day 1 - Prasugrel (60mg) at 1.0 hr
n=3 participants at risk
Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.0 hour after infusion start).
|
Day 1 - Prasugrel (60mg) - Post Infusion (2.0 hr)
n=3 participants at risk
Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) post infusion, \[at 2.0 hrs, (within 5 minutes of discontinuing the cangrelor infusion)\].
|
Day 8 - Prasugrel (10mg) Dosing (6 Doses)
n=6 participants at risk
Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)
Subjects were given 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
|
Day 8 - Prasugrel (10mg) Dosing (5 Doses)
n=6 participants at risk
Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)
Subjects were given 5 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • Screening through Follow-up Period
Follow-up period: Each subject was contacted by telephone 5 to 7 days after Study Day 8 to assess adverse event (AEs) / serious adverse events (SAEs) and to ensure that any previously identified AEs/SAEs had resolved.
|
0.00%
0/3 • Screening through Follow-up Period
Follow-up period: Each subject was contacted by telephone 5 to 7 days after Study Day 8 to assess adverse event (AEs) / serious adverse events (SAEs) and to ensure that any previously identified AEs/SAEs had resolved.
|
0.00%
0/3 • Screening through Follow-up Period
Follow-up period: Each subject was contacted by telephone 5 to 7 days after Study Day 8 to assess adverse event (AEs) / serious adverse events (SAEs) and to ensure that any previously identified AEs/SAEs had resolved.
|
0.00%
0/6 • Screening through Follow-up Period
Follow-up period: Each subject was contacted by telephone 5 to 7 days after Study Day 8 to assess adverse event (AEs) / serious adverse events (SAEs) and to ensure that any previously identified AEs/SAEs had resolved.
|
0.00%
0/6 • Screening through Follow-up Period
Follow-up period: Each subject was contacted by telephone 5 to 7 days after Study Day 8 to assess adverse event (AEs) / serious adverse events (SAEs) and to ensure that any previously identified AEs/SAEs had resolved.
|
|
General disorders
Infusion site hemmorrhage
|
16.7%
1/6 • Number of events 1 • Screening through Follow-up Period
Follow-up period: Each subject was contacted by telephone 5 to 7 days after Study Day 8 to assess adverse event (AEs) / serious adverse events (SAEs) and to ensure that any previously identified AEs/SAEs had resolved.
|
0.00%
0/3 • Screening through Follow-up Period
Follow-up period: Each subject was contacted by telephone 5 to 7 days after Study Day 8 to assess adverse event (AEs) / serious adverse events (SAEs) and to ensure that any previously identified AEs/SAEs had resolved.
|
0.00%
0/3 • Screening through Follow-up Period
Follow-up period: Each subject was contacted by telephone 5 to 7 days after Study Day 8 to assess adverse event (AEs) / serious adverse events (SAEs) and to ensure that any previously identified AEs/SAEs had resolved.
|
0.00%
0/6 • Screening through Follow-up Period
Follow-up period: Each subject was contacted by telephone 5 to 7 days after Study Day 8 to assess adverse event (AEs) / serious adverse events (SAEs) and to ensure that any previously identified AEs/SAEs had resolved.
|
0.00%
0/6 • Screening through Follow-up Period
Follow-up period: Each subject was contacted by telephone 5 to 7 days after Study Day 8 to assess adverse event (AEs) / serious adverse events (SAEs) and to ensure that any previously identified AEs/SAEs had resolved.
|
Additional Information
Jayne Prats, PhD - VP, Global Knowledge Management
The Medicines Company
Phone: 888-779-MDCO
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submission for publication or presentation, the Institution will provide the Sponsor thirty (30) days for review and comment, If necessary, Sponsor will be given an additional sixty (60) days to allow Sponsor to file a patent application or taking such other measures as Sponsor deems appropriate to establish and preserve its proprietary rights upon the manuscript or other material for such publication. Sponsor may remove confidential or proprietary information.
- Publication restrictions are in place
Restriction type: OTHER