Trial Outcomes & Findings for Cangrelor to Clopidogrel or Prasugrel Transition Study (NCT NCT01979445)
NCT ID: NCT01979445
Last Updated: 2020-02-26
Results Overview
A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using light transmittance aggregometry (LTA). LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (sec) (final/terminal aggregation response).
COMPLETED
PHASE2
15 participants
Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion
2020-02-26
Participant Flow
Participant milestones
| Measure |
Prasugrel 30 Min After Cangrelor
Cangrelor intravenously (IV) was administered on Day 1 as a 30 microgram (μg)/kilogram (kg) bolus, followed by 4 μg/kg/minute (min) infusion for 2 hours (hrs).
Prasugrel 60 milligram (mg) was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).
|
Clopidogrel Within 5 Min After Cangrelor
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).
|
Clopidogrel 1.5 Hrs During Cangrelor
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion.
|
Clopidogrel 1 Hr During Cangrelor
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
3
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
3
|
3
|
6
|
3
|
|
Overall Study
ITT Population
|
3
|
3
|
6
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cangrelor to Clopidogrel or Prasugrel Transition Study
Baseline characteristics by cohort
| Measure |
Prasugrel
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min on Day 1 after the discontinuation of cangrelor infusion.
|
Clopidogrel
n=12 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs on Day 1.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 and 1.5 hrs after the initiation of cangrelor infusion and within 5 min after the discontinuation of the cangrelor infusion.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 6.66 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 6.18 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 6.15 • 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
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 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
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 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
|
|
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
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 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
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusionPopulation: Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.
A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using light transmittance aggregometry (LTA). LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (sec) (final/terminal aggregation response).
Outcome measures
| Measure |
Prasugrel 30 Min After Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).
|
Clopidogrel Within 5 Min After Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).
|
Clopidogrel 1.5 Hrs During Cangrelor
n=6 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion.
|
Clopidogrel 1 Hr During Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion.
|
|---|---|---|---|---|
|
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone
Prasugrel/Clopidogrel Reference (6 or 5.5 hrs)
|
1.3 % aggregation
Standard Deviation 1.5
|
21.7 % aggregation
Standard Deviation 16.4
|
50.0 % aggregation
Standard Deviation 16.8
|
50.3 % aggregation
Standard Deviation 15.9
|
|
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone
2.25 hrs
|
16.3 % aggregation
Standard Deviation 10.1
|
26.0 % aggregation
Standard Deviation 7.9
|
22.2 % aggregation
Standard Deviation 16.0
|
33.3 % aggregation
Standard Deviation 7.5
|
|
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone
2.5 hrs
|
60.0 % aggregation
Standard Deviation 7.5
|
49.7 % aggregation
Standard Deviation 7.1
|
54.3 % aggregation
Standard Deviation 11.7
|
62.0 % aggregation
Standard Deviation 3.6
|
|
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone
2.75 hrs
|
63.3 % aggregation
Standard Deviation 1.5
|
58.3 % aggregation
Standard Deviation 7.4
|
56.8 % aggregation
Standard Deviation 11.3
|
67.7 % aggregation
Standard Deviation 1.2
|
|
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone
3 hrs
|
65.0 % aggregation
Standard Deviation 2.0
|
56.0 % aggregation
Standard Deviation 8.9
|
56.2 % aggregation
Standard Deviation 16.4
|
65.0 % aggregation
Standard Deviation 9.5
|
|
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone
4 hrs
|
16.3 % aggregation
Standard Deviation 27.4
|
38.0 % aggregation
Standard Deviation 31.7
|
51.2 % aggregation
Standard Deviation 27.4
|
62.7 % aggregation
Standard Deviation 8.5
|
|
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone
5.5 hrs
|
1.3 % aggregation
Standard Deviation 1.5
|
26.7 % aggregation
Standard Deviation 20.5
|
NA % aggregation
Standard Deviation NA
Per protocol, analysis was not performed at 5.5 hrs for this arm.
|
NA % aggregation
Standard Deviation NA
Per protocol, analysis was not performed at 5.5 hrs for this arm.
|
PRIMARY outcome
Timeframe: Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusionPopulation: Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.
A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using LTA. LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was examined using LTA and expressed as % aggregation in response to 20 μM ADP at 300 sec (final/terminal aggregation response).
Outcome measures
| Measure |
Prasugrel 30 Min After Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).
|
Clopidogrel Within 5 Min After Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).
|
Clopidogrel 1.5 Hrs During Cangrelor
n=6 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion.
|
Clopidogrel 1 Hr During Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion.
|
|---|---|---|---|---|
|
Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone
Cangrelor Reference (2.5, 2, 1.5, or 1 hrs)
|
60.0 % aggregation
Standard Deviation 7.5
|
0 % aggregation
Standard Deviation 0
|
2.0 % aggregation
Standard Deviation 3.5
|
3.0 % aggregation
Standard Deviation 2.0
|
|
Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone
1.75 hrs
|
0.3 % aggregation
Standard Deviation 0.6
|
1.0 % aggregation
Standard Deviation 1.0
|
1.8 % aggregation
Standard Deviation 2.5
|
1.3 % aggregation
Standard Deviation 0.6
|
|
Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone
2 hrs
|
0.3 % aggregation
Standard Deviation 0.6
|
NA % aggregation
Standard Deviation NA
Per protocol, analysis was not performed at 2 hrs for this arm.
|
1.5 % aggregation
Standard Deviation 2.0
|
2.3 % aggregation
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusionPopulation: Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.
A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was assessed by platelet reaction units (PRU), determined by the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay is designed to directly measure the effects of drugs on the P2Y12 receptor, using prostaglandin E1 in addition to ADP to increase intraplatelet cyclic adenosine monophosphate (cAMP). Platelet reactivity was expressed in PRU.
Outcome measures
| Measure |
Prasugrel 30 Min After Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).
|
Clopidogrel Within 5 Min After Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).
|
Clopidogrel 1.5 Hrs During Cangrelor
n=6 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion.
|
Clopidogrel 1 Hr During Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion.
|
|---|---|---|---|---|
|
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay
Prasugrel/Clopidogrel Reference (6 or 5.5 hrs)
|
8.0 PRU
Standard Deviation 8.7
|
159.0 PRU
Standard Deviation 72.7
|
211.3 PRU
Standard Deviation 66.8
|
197.3 PRU
Standard Deviation 15.0
|
|
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay
2.25 hrs
|
76.7 PRU
Standard Deviation 23.7
|
99.0 PRU
Standard Deviation 27.6
|
90.3 PRU
Standard Deviation 32.3
|
98.7 PRU
Standard Deviation 19.6
|
|
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay
2.5 hrs
|
208.0 PRU
Standard Deviation 30.2
|
220.7 PRU
Standard Deviation 11.6
|
229.8 PRU
Standard Deviation 24.6
|
206.3 PRU
Standard Deviation 26.9
|
|
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay
2.75 hrs
|
225.7 PRU
Standard Deviation 42.5
|
233.0 PRU
Standard Deviation 21.7
|
255.8 PRU
Standard Deviation 43.7
|
214.3 PRU
Standard Deviation 11.9
|
|
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay
3 hrs
|
226.0 PRU
Standard Deviation 28.5
|
215.7 PRU
Standard Deviation 35.0
|
234.5 PRU
Standard Deviation 34.2
|
212.7 PRU
Standard Deviation 10.3
|
|
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay
4 hrs
|
77.0 PRU
Standard Deviation 126.5
|
182.0 PRU
Standard Deviation 82.3
|
215.5 PRU
Standard Deviation 67.4
|
203.7 PRU
Standard Deviation 11.2
|
|
Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay
5.5 hrs
|
24.5 PRU
Standard Deviation 34.6
|
155.0 PRU
Standard Deviation 69.8
|
NA PRU
Standard Deviation NA
Per protocol, analysis was not performed for this arm at 5.5 hrs.
|
NA PRU
Standard Deviation NA
Per protocol, analysis was not performed for this arm at 5.5 hrs.
|
SECONDARY outcome
Timeframe: Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusionPopulation: Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.
A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was assessed by PRU, determined by the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay is designed to directly measure the effects of drugs on the P2Y12 receptor, using prostaglandin E1 in addition to ADP to increase intraplatelet cAMP. Platelet reactivity was expressed in PRU.
Outcome measures
| Measure |
Prasugrel 30 Min After Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).
|
Clopidogrel Within 5 Min After Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).
|
Clopidogrel 1.5 Hrs During Cangrelor
n=6 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion.
|
Clopidogrel 1 Hr During Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion.
|
|---|---|---|---|---|
|
Extent of Preservation of Platelet Inhibitory Effect of Cangrelor Treatment After Prasugrel or Clopidogrel Compared to Treatment With Cangrelor Alone Determined By VerifyNow P2Y12 Assay
Cangrelor Reference (2.5, 2, 1.5, or 1 hrs)
|
208.0 PRU
Standard Deviation 30.2
|
7.3 PRU
Standard Deviation 5.1
|
17.7 PRU
Standard Deviation 18.2
|
7.0 PRU
Standard Deviation 2.0
|
|
Extent of Preservation of Platelet Inhibitory Effect of Cangrelor Treatment After Prasugrel or Clopidogrel Compared to Treatment With Cangrelor Alone Determined By VerifyNow P2Y12 Assay
1.75 hrs
|
3.3 PRU
Standard Deviation 2.3
|
3.7 PRU
Standard Deviation 2.1
|
25.0 PRU
Standard Deviation 30.5
|
6.3 PRU
Standard Deviation 1.5
|
|
Extent of Preservation of Platelet Inhibitory Effect of Cangrelor Treatment After Prasugrel or Clopidogrel Compared to Treatment With Cangrelor Alone Determined By VerifyNow P2Y12 Assay
2 hrs
|
5.3 PRU
Standard Deviation 2.1
|
NA PRU
Standard Deviation NA
Per protocol, analysis was not performed for this arm at 2 hrs.
|
28.8 PRU
Standard Deviation 18.2
|
5.7 PRU
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Screening through the follow-up period (5 to 7 days after Day 1)Population: Safety Population included all participants who received at least 1 dose of study drug.
Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Day 1. Reports of bleeding were to be evaluated by performance of a CBC. Participants were assessed for bleeding events in accordance with the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) scale. The severity of bleeding events by GUSTO Criteria is defined as the following: * Severe/life-threatening: fatal, intracranial hemorrhage, or if hemodynamic compromise results * Moderate: transfusion required * Mild: no transfusion or hemodynamic compromise A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Prasugrel 30 Min After Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Prasugrel 60 mg was administered on Day 1 as a single oral dose 30 min after the discontinuation of cangrelor infusion (2.5 hrs after initiation of cangrelor infusion).
|
Clopidogrel Within 5 Min After Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose within 5 min after the discontinuation of the cangrelor infusion (2 hrs after initiation of cangrelor infusion).
|
Clopidogrel 1.5 Hrs During Cangrelor
n=6 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1.5 hrs following the initiation of cangrelor infusion.
|
Clopidogrel 1 Hr During Cangrelor
n=3 Participants
Cangrelor IV was administered on Day 1 as a 30 μg/kg bolus, followed by 4 μg/kg/min infusion for 2 hrs.
Clopidogrel 600 mg was administered on Day 1 as a single oral dose 1 hr following the initiation of cangrelor infusion.
|
|---|---|---|---|---|
|
Bleeding Events In Accordance With GUSTO Scale
Mild
|
0 bleeding events
|
0 bleeding events
|
0 bleeding events
|
0 bleeding events
|
|
Bleeding Events In Accordance With GUSTO Scale
Moderate
|
0 bleeding events
|
0 bleeding events
|
0 bleeding events
|
0 bleeding events
|
|
Bleeding Events In Accordance With GUSTO Scale
Life-threatening/Severe
|
0 bleeding events
|
0 bleeding events
|
0 bleeding events
|
0 bleeding events
|
Adverse Events
Prasugrel 30 Min After Cangrelor
Clopidogrel Within 5 Min After Cangrelor
Clopidogrel 1.5 Hrs During Cangrelor
Clopidogrel 1 Hr During Cangrelor
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Global Health Science Center, The Medicines Company
The Medicines Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place