Trial Outcomes & Findings for A Clinical Trial to Demonstrate the Efficacy of Cangrelor (NCT NCT00305162)
NCT ID: NCT00305162
Last Updated: 2014-05-08
Results Overview
(composite incidence)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
8882 participants
Primary outcome timeframe
randomization through 48 hours after randomization
Results posted on
2014-05-08
Participant Flow
Patients were selected for randomization based on the need for percutaneous coronary intervention (PCI). Randomization could only occur after the need for PCI was confirmed by angiography, with the exception of ST-segment elevation myocardial infarction (STEMI) patients, who could be enrolled upon confirmation of STEMI by electrocardiogram (ECG).
Participant milestones
| Measure |
Cangrelor Arm
cangrelor arm: placebo capsules at PCI start + cangrelor bolus(30 mcg/kg) \& infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
|
Clopidogrel Arm
clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion followed by placebo capsules post infusion
|
|---|---|---|
|
48 Hour Follow-up Period
STARTED
|
4435
|
4447
|
|
48 Hour Follow-up Period
Intent-to-treat (ITT): SA/UA/NSTEMI
|
3933
|
3924
|
|
48 Hour Follow-up Period
Intent-to-treat (ITT): STEMI
|
482
|
507
|
|
48 Hour Follow-up Period
Modified ITT (mITT): SA/UA/NSTEMI
|
3889
|
3865
|
|
48 Hour Follow-up Period
Modified ITT (mITT): STEMI
|
446
|
447
|
|
48 Hour Follow-up Period
Safety Population
|
4374
|
4365
|
|
48 Hour Follow-up Period
COMPLETED
|
4415
|
4431
|
|
48 Hour Follow-up Period
NOT COMPLETED
|
20
|
16
|
|
30-day Follow-up Period
STARTED
|
4435
|
4447
|
|
30-day Follow-up Period
Intent-to-treat (ITT): SA/UA/NSTEMI
|
3902
|
3883
|
|
30-day Follow-up Period
Intent-to-treat (ITT): STEMI
|
471
|
501
|
|
30-day Follow-up Period
Modified ITT (mITT): SA/UA/NSTEMI
|
3860
|
3827
|
|
30-day Follow-up Period
Modified ITT (mITT): STEMI
|
438
|
444
|
|
30-day Follow-up Period
COMPLETED
|
4373
|
4384
|
|
30-day Follow-up Period
NOT COMPLETED
|
62
|
63
|
|
1 Year Follow-up Period
STARTED
|
4435
|
4447
|
|
1 Year Follow-up Period
Intent-to-treat (ITT): SA/UA/NSTEMI
|
3900
|
3878
|
|
1 Year Follow-up Period
Intent-to-treat (ITT): STEMI
|
480
|
504
|
|
1 Year Follow-up Period
Modified ITT (mITT): SA/UA/NSTEMI
|
3851
|
3818
|
|
1 Year Follow-up Period
Modified ITT (mITT): STEMI
|
446
|
444
|
|
1 Year Follow-up Period
COMPLETED
|
4380
|
4382
|
|
1 Year Follow-up Period
NOT COMPLETED
|
55
|
65
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial to Demonstrate the Efficacy of Cangrelor
Baseline characteristics by cohort
| Measure |
Cangrelor Arm
n=4433 Participants
cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
|
Clopidogrel Arm
n=4444 Participants
clopidogrel arm: clopidogrel capsules (600 mg) at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
Total
n=8877 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
62.2 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1158 Participants
n=5 Participants
|
1235 Participants
n=7 Participants
|
2393 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3275 Participants
n=5 Participants
|
3209 Participants
n=7 Participants
|
6484 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2629 participants
n=5 Participants
|
2638 participants
n=7 Participants
|
5267 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
233 participants
n=5 Participants
|
237 participants
n=7 Participants
|
470 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
215 participants
n=5 Participants
|
215 participants
n=7 Participants
|
430 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
111 participants
n=5 Participants
|
116 participants
n=7 Participants
|
227 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Georgia
|
228 participants
n=5 Participants
|
230 participants
n=7 Participants
|
458 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
162 participants
n=5 Participants
|
156 participants
n=7 Participants
|
318 participants
n=5 Participants
|
|
Region of Enrollment
India
|
260 participants
n=5 Participants
|
260 participants
n=7 Participants
|
520 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
169 participants
n=5 Participants
|
167 participants
n=7 Participants
|
336 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
110 participants
n=5 Participants
|
116 participants
n=7 Participants
|
226 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
231 participants
n=5 Participants
|
232 participants
n=7 Participants
|
463 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
39 participants
n=5 Participants
|
39 participants
n=7 Participants
|
78 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: randomization through 48 hours after randomizationPopulation: mITT (excluding STEMI)
(composite incidence)
Outcome measures
| Measure |
Cangrelor Arm
n=3889 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=3865 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
|
290 participants
Interval 0.89 to 1.24
|
276 participants
Interval 0.98 to 1.24
|
SECONDARY outcome
Timeframe: randomization through 48 hours after randomizationPopulation: mITT (excluding STEMI)
(composite incidence)
Outcome measures
| Measure |
Cangrelor Arm
n=3889 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=3865 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of All-cause Mortality and MI
|
285 participants
|
261 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours after randomizationPopulation: mITT (excluding STEMI)
Outcome measures
| Measure |
Cangrelor Arm
n=3889 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=3865 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Individual Incidence of All-cause Mortality
|
8 participants
|
5 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours after randomizationPopulation: mITT (excluding STEMI)
Outcome measures
| Measure |
Cangrelor Arm
n=3889 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=3865 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Individual Incidence of IDR
|
13 participants
|
23 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours after randomizationPopulation: mITT (excluding STEMI)
Stroke is defined as a sudden, focal neurological defect resulting from a cerebrovascular cause that is not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or trauma. All suspected strokes were reviewed and adjudicated by the Clinical Events Committee (CEC) who considered all clinically relevant information and imaging studies to classify all strokes as: * primary hemorrhagic - stroke with focal collections of intracranial blood * ischemic cerebral infarction - stroke without focal collections of intracranial blood * infarction with hemorrhagic conversion - cerebral infarction with blood thought to represent hemorrhagic conversion and not primary bleeding * uncertain - no imaging or autopsy data are available.
Outcome measures
| Measure |
Cangrelor Arm
n=3889 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=3865 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of Stroke
primary hemorrhagic
|
1 participants
|
0 participants
|
|
Incidence of Stroke
infarction with hemorrhagic conversion
|
0 participants
|
0 participants
|
|
Incidence of Stroke
cerebral infarction
|
5 participants
|
7 participants
|
|
Incidence of Stroke
uncertain type
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: during index PCIPopulation: mITT (excluding STEMI) and based on available data
(a patient could have multiple procedural events)
Outcome measures
| Measure |
Cangrelor Arm
n=3897 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=3871 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI
|
127 participants
|
141 participants
|
SECONDARY outcome
Timeframe: randomization through 30 days after randomizationPopulation: mITT (excluding STEMI), based on 30-day completers
(composite incidence)
Outcome measures
| Measure |
Cangrelor Arm
n=3860 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=3827 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of All-cause Mortality, MI or IDR
|
343 participants
|
327 participants
|
SECONDARY outcome
Timeframe: randomization through 30 days after randomizationPopulation: mITT (excluding STEMI), based on 30-day completers
(composite incidence)
Outcome measures
| Measure |
Cangrelor Arm
n=3860 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=3827 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of All-cause Mortality or MI
|
321 participants
|
298 participants
|
SECONDARY outcome
Timeframe: randomization through 30 days after randomizationPopulation: mITT (excluding STEMI), based on 30-day completers
Outcome measures
| Measure |
Cangrelor Arm
n=3860 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=3827 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of All-cause Mortality
|
34 participants
|
29 participants
|
SECONDARY outcome
Timeframe: randomization through 30 days after randomizationPopulation: mITT (excluding STEMI), based on 30-day completers
Outcome measures
| Measure |
Cangrelor Arm
n=3860 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=3827 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of MI
|
297 participants
|
276 participants
|
SECONDARY outcome
Timeframe: randomization through 30 days after randomizationPopulation: mITT (excluding STEMI), based on 30-day completers
Outcome measures
| Measure |
Cangrelor Arm
n=3860 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=3827 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of IDR
|
44 participants
|
52 participants
|
SECONDARY outcome
Timeframe: randomization through 30 days after randomizationPopulation: mITT (excluding STEMI), based on available data
Outcome measures
| Measure |
Cangrelor Arm
n=3860 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=3827 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of Stroke
|
5 participants
|
7 participants
|
SECONDARY outcome
Timeframe: randomization through 1 year after randomizationPopulation: mITT (excluding STEMI), based on 1 year completers
(excluding STEMI)
Outcome measures
| Measure |
Cangrelor Arm
n=3851 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=3818 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of All Cause Mortality
|
116 participants
Interval 0.75 to 1.2
|
120 participants
Interval 0.75 to 1.2
|
SECONDARY outcome
Timeframe: randomization through 48 hours after randomizationPopulation: Safety Population (inclusive of STEMI patients)
Major bleeding (non-CABG-related) - Safety population
Outcome measures
| Measure |
Cangrelor Arm
n=4374 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=4365 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of GUSTO Severe / Life-threatening Bleeding
|
10 participants
|
11 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours after randomizationPopulation: Safety Population (inclusive of STEMI patients)
Major bleeding (non-CABG-related) - Safety population
Outcome measures
| Measure |
Cangrelor Arm
n=4374 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=4365 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
|
19 participants
|
14 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours after randomizationPopulation: Safety Population (inclusive of STEMI patients)
Major bleeding (non-CABG-related) - Safety population
Outcome measures
| Measure |
Cangrelor Arm
n=4374 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=4365 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of ACUITY Major Bleeding
|
151 participants
|
120 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours after randomizationPopulation: Safety Population (inclusive of STEMI patients)
excludes ACUITY major bleeding for which the only qualifying event was hematoma \>/= 5 cm
Outcome measures
| Measure |
Cangrelor Arm
n=4374 Participants
placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
|
Clopidogrel Arm
n=4365 Participants
clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)
|
78 participants
|
65 participants
|
Adverse Events
Cangrelor Arm
Serious events: 125 serious events
Other events: 1149 other events
Deaths: 0 deaths
Clopidogrel Arm
Serious events: 127 serious events
Other events: 1159 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cangrelor Arm
n=4374 participants at risk
cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
|
Clopidogrel Arm
n=4365 participants at risk
clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
anaemia
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Blood and lymphatic system disorders
haemolytic anaemia
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Blood and lymphatic system disorders
haemorrhagic anaemia
|
0.00%
0/4374
|
0.05%
2/4365
|
|
Blood and lymphatic system disorders
leukocytosis
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/4374
|
0.05%
2/4365
|
|
Cardiac disorders
acute myocardial infarction
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Cardiac disorders
angina pectoris
|
0.09%
4/4374
|
0.07%
3/4365
|
|
Cardiac disorders
arrhythmia
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Cardiac disorders
arrhythmia supraventricular
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Cardiac disorders
arteriospasm coronary
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Cardiac disorders
atrial fibrillation
|
0.05%
2/4374
|
0.05%
2/4365
|
|
Cardiac disorders
atrial flutter
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Cardiac disorders
atrial tachycardia
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Cardiac disorders
atrioventricular block
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Cardiac disorders
atrioventricular block third degree
|
0.05%
2/4374
|
0.05%
2/4365
|
|
Cardiac disorders
bradycardia
|
0.05%
2/4374
|
0.07%
3/4365
|
|
Cardiac disorders
cardiac arrest
|
0.09%
4/4374
|
0.14%
6/4365
|
|
Cardiac disorders
cardiac failure
|
0.05%
2/4374
|
0.00%
0/4365
|
|
Cardiac disorders
cardiac failure acute
|
0.02%
1/4374
|
0.02%
1/4365
|
|
Cardiac disorders
cardiac failure congestive
|
0.09%
4/4374
|
0.07%
3/4365
|
|
Cardiac disorders
cardiac tamponade
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Cardiac disorders
cardiogenic shock
|
0.14%
6/4374
|
0.18%
8/4365
|
|
Cardiac disorders
coronary artery dissection
|
0.11%
5/4374
|
0.07%
3/4365
|
|
Cardiac disorders
coronary artery occlusion
|
0.00%
0/4374
|
0.07%
3/4365
|
|
Cardiac disorders
coronary artery perforation
|
0.09%
4/4374
|
0.05%
2/4365
|
|
Cardiac disorders
coronary artery thrombosis
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Cardiac disorders
in-stent arterial restenosis
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Cardiac disorders
nodal rhythm
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Cardiac disorders
pericardial effusion
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Cardiac disorders
sick sinus syndrome
|
0.07%
3/4374
|
0.00%
0/4365
|
|
Cardiac disorders
sinus arrest
|
0.00%
0/4374
|
0.05%
2/4365
|
|
Cardiac disorders
supraventricular tachycardia
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Cardiac disorders
ventricular arrhythmia
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Cardiac disorders
ventricular asystole
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Cardiac disorders
ventricular fibrillation
|
0.27%
12/4374
|
0.14%
6/4365
|
|
Cardiac disorders
ventricular tachycardia
|
0.09%
4/4374
|
0.11%
5/4365
|
|
Eye disorders
retinal artery occlusion
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Gastrointestinal disorders
abdominal pain upper
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Gastrointestinal disorders
haematemesis
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Gastrointestinal disorders
retroperitoneal haemorrhage
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/4374
|
0.05%
2/4365
|
|
General disorders
cardiac death
|
0.02%
1/4374
|
0.00%
0/4365
|
|
General disorders
chest discomfort
|
0.00%
0/4374
|
0.02%
1/4365
|
|
General disorders
chest pain
|
0.16%
7/4374
|
0.21%
9/4365
|
|
General disorders
non-cardiac chest pain
|
0.05%
2/4374
|
0.02%
1/4365
|
|
General disorders
puncture site haemorrhage
|
0.00%
0/4374
|
0.02%
1/4365
|
|
General disorders
pyrexia
|
0.02%
1/4374
|
0.00%
0/4365
|
|
General disorders
sudden cardiac death
|
0.02%
1/4374
|
0.00%
0/4365
|
|
General disorders
sudden death
|
0.00%
0/4374
|
0.02%
1/4365
|
|
General disorders
vessel puncture site haematoma
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Hepatobiliary disorders
cholecystitis acute
|
0.02%
1/4374
|
0.05%
2/4365
|
|
Hepatobiliary disorders
gallbladder disorder
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Infections and infestations
bronchitis
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Infections and infestations
bronchitis viral
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Infections and infestations
cellulitis
|
0.05%
2/4374
|
0.00%
0/4365
|
|
Infections and infestations
haematoma infection
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Infections and infestations
pneumonia
|
0.02%
1/4374
|
0.07%
3/4365
|
|
Infections and infestations
sepsis
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Infections and infestations
urinary tract infection
|
0.07%
3/4374
|
0.00%
0/4365
|
|
Injury, poisoning and procedural complications
fibula fracture
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Injury, poisoning and procedural complications
thrombosis in device
|
0.02%
1/4374
|
0.07%
3/4365
|
|
Injury, poisoning and procedural complications
vascular procedure complication
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Investigations
aspartate aminotransferase increased
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Investigations
cardiac enzymes increased
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Investigations
liver function test abnormal
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Metabolism and nutrition disorders
gout
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
0.02%
1/4374
|
0.02%
1/4365
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Nervous system disorders
cerebral haemorrhage
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Nervous system disorders
diabetic neuropathy
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Nervous system disorders
presyncope
|
0.05%
2/4374
|
0.05%
2/4365
|
|
Nervous system disorders
syncope
|
0.02%
1/4374
|
0.02%
1/4365
|
|
Psychiatric disorders
alcohol withdrawal syndrome
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Psychiatric disorders
depression
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Psychiatric disorders
mental status changes
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Renal and urinary disorders
renal artery stenosis
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Renal and urinary disorders
renal failure
|
0.05%
2/4374
|
0.02%
1/4365
|
|
Renal and urinary disorders
renal failure acute
|
0.25%
11/4374
|
0.11%
5/4365
|
|
Renal and urinary disorders
renal failure chronic
|
0.00%
0/4374
|
0.05%
2/4365
|
|
Respiratory, thoracic and mediastinal disorders
acute pulmonary oedema
|
0.09%
4/4374
|
0.00%
0/4365
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.02%
1/4374
|
0.02%
1/4365
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary congestion
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.05%
2/4374
|
0.05%
2/4365
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary oedema
|
0.05%
2/4374
|
0.05%
2/4365
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
0.00%
0/4374
|
0.05%
2/4365
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.07%
3/4374
|
0.05%
2/4365
|
|
Skin and subcutaneous tissue disorders
angioneurotic oedema
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Surgical and medical procedures
stent removal
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Vascular disorders
arterial thrombosis limb
|
0.02%
1/4374
|
0.02%
1/4365
|
|
Vascular disorders
artery dissection
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Vascular disorders
embolism
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Vascular disorders
femoral artery dissection
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Vascular disorders
femoral artery occlusion
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Vascular disorders
haemodynamic instability
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Vascular disorders
hypertension
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Vascular disorders
hypertensive emergency
|
0.00%
0/4374
|
0.05%
2/4365
|
|
Vascular disorders
hypotension
|
0.16%
7/4374
|
0.18%
8/4365
|
|
Vascular disorders
orthostatic hypotension
|
0.02%
1/4374
|
0.00%
0/4365
|
|
Vascular disorders
peripheral ischaemia
|
0.02%
1/4374
|
0.02%
1/4365
|
|
Vascular disorders
reperfusion injury
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Vascular disorders
shock haemorrhagic
|
0.00%
0/4374
|
0.02%
1/4365
|
|
Vascular disorders
thrombosis
|
0.02%
1/4374
|
0.02%
1/4365
|
|
Vascular disorders
vascular pseudoaneurysm
|
0.02%
1/4374
|
0.00%
0/4365
|
Other adverse events
| Measure |
Cangrelor Arm
n=4374 participants at risk
cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) \& infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
|
Clopidogrel Arm
n=4365 participants at risk
clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus \& infusion (to match) followed by placebo capsules post infusion
|
|---|---|---|
|
General disorders
chest pain
|
4.1%
178/4374
|
3.7%
163/4365
|
|
Musculoskeletal and connective tissue disorders
back pain
|
3.8%
167/4374
|
3.8%
164/4365
|
|
Gastrointestinal disorders
nausea
|
2.6%
112/4374
|
3.3%
145/4365
|
|
Vascular disorders
hypotension
|
2.2%
97/4374
|
2.0%
89/4365
|
|
Nervous system disorders
headache
|
2.1%
93/4374
|
2.2%
97/4365
|
|
Gastrointestinal disorders
vomiting
|
1.6%
70/4374
|
1.8%
78/4365
|
|
General disorders
puncture site pain
|
1.5%
67/4374
|
1.2%
52/4365
|
|
General disorders
pyrexia
|
1.0%
45/4374
|
0.85%
37/4365
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.96%
42/4374
|
0.37%
16/4365
|
|
Cardiac disorders
ventricular tachycardia
|
0.85%
37/4374
|
0.80%
35/4365
|
|
Vascular disorders
hypertension
|
0.73%
32/4374
|
0.78%
34/4365
|
|
General disorders
chest discomfort
|
0.73%
32/4374
|
0.55%
24/4365
|
|
Cardiac disorders
bradycardia
|
0.66%
29/4374
|
0.80%
35/4365
|
|
Cardiac disorders
atrial fibrillation
|
0.62%
27/4374
|
0.41%
18/4365
|
|
Cardiac disorders
angina pectoris
|
0.46%
20/4374
|
0.78%
34/4365
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.46%
20/4374
|
0.55%
24/4365
|
|
Nervous system disorders
syncope vasovagal
|
0.39%
17/4374
|
0.60%
26/4365
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.39%
17/4374
|
0.53%
23/4365
|
|
Nervous system disorders
dizziness
|
0.39%
17/4374
|
0.48%
21/4365
|
|
Psychiatric disorders
anxiety
|
0.37%
16/4374
|
0.50%
22/4365
|
|
Gastrointestinal disorders
dyspepsia
|
0.32%
14/4374
|
0.50%
22/4365
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI communications regarding trial results are prohibited until after the communication and publication of the multi-center results by Sponsor, but no more than 12 months after conclusion of the trial at all sites. PI must submit results communications to sponsor for review at least 40 days prior to submission for publication and Sponsor may embargo such communications for a period that is less than or equal to 135 days solely to seek appropriate patent protection.
- Publication restrictions are in place
Restriction type: OTHER