Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 27 for:    cangrelor

A Clinical Trial to Demonstrate the Efficacy of Cangrelor (PCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00305162
Recruitment Status : Terminated (Insufficient evidence of the clinical effectiveness of cangrelor)
First Posted : March 21, 2006
Results First Posted : April 23, 2014
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Myocardial Infarction (MI)
Acute Coronary Syndromes (ACS)
Interventions Drug: Cangrelor (P2Y12 inhibitor)
Drug: clopidogrel (oral P2Y12 inhibitor)
Drug: Placebo bolus & placebo infusion
Drug: Placebo capsules - end of infusion
Drug: Placebo capsules - as soon as possible after randomization
Enrollment 8882
Recruitment Details 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).
Pre-assignment Details  
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description 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 capsules (600 mg)at PCI start + placebo bolus & infusion followed by placebo capsules post infusion
Period Title: 48 Hour Follow-up Period
Started 4435 4447
Intent-to-treat (ITT): SA/UA/NSTEMI 3933 [1] 3924 [1]
Intent-to-treat (ITT): STEMI 482 [1] 507 [1]
Modified ITT (mITT): SA/UA/NSTEMI 3889 [2] 3865 [2]
Modified ITT (mITT): STEMI 446 [2] 447 [2]
Safety Population 4374 [3] 4365 [3]
Completed 4415 [4] 4431 [4]
Not Completed 20 16
[1]
Patients who completed through 48 hours
[2]
Completed through 48 hours; Excludes those who did not receive study drug or undergo index PCI.
[3]
Patients who received at least 1 dose of study drug, according to the actual treatment received.
[4]
intent-to-treat (ITT) completers at 48 hour follow-up
Period Title: 30-day Follow-up Period
Started 4435 4447
Intent-to-treat (ITT): SA/UA/NSTEMI 3902 [1] 3883 [1]
Intent-to-treat (ITT): STEMI 471 [1] 501 [1]
Modified ITT (mITT): SA/UA/NSTEMI 3860 [2] 3827 [2]
Modified ITT (mITT): STEMI 438 [2] 444 [2]
Completed 4373 [3] 4384 [3]
Not Completed 62 63
[1]
Completed through 30-days
[2]
Completed through 30-days; Excludes those who did not receive study drug or undergo index PCI.
[3]
intent-to-treat (ITT) completers at 30-day follow-up
Period Title: 1 Year Follow-up Period
Started 4435 4447
Intent-to-treat (ITT): SA/UA/NSTEMI 3900 [1] 3878 [1]
Intent-to-treat (ITT): STEMI 480 [1] 504 [1]
Modified ITT (mITT): SA/UA/NSTEMI 3851 [2] 3818 [2]
Modified ITT (mITT): STEMI 446 [2] 444 [2]
Completed 4380 [3] 4382 [3]
Not Completed 55 65
[1]
Completed through 1 year
[2]
Completed through 1 year; Excludes those who did not receive study drug or undergo index PCI.
[3]
intent-to-treat (ITT) completers at 1-year follow-up
Arm/Group Title Cangrelor Arm Clopidogrel Arm Total
Hide Arm/Group Description 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: clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion Total of all reporting groups
Overall Number of Baseline Participants 4433 4444 8877
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4433 participants 4444 participants 8877 participants
62.2  (11.3) 62.2  (11.5) 62.2  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4433 participants 4444 participants 8877 participants
Female
1158
  26.1%
1235
  27.8%
2393
  27.0%
Male
3275
  73.9%
3209
  72.2%
6484
  73.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4433 participants 4444 participants 8877 participants
United States 2629 2638 5267
Australia 233 237 470
Argentina 25 26 51
Austria 215 215 430
Brazil 111 116 227
Canada 10 5 15
Georgia 228 230 458
Germany 162 156 318
India 260 260 520
Italy 169 167 336
New Zealand 110 116 226
Poland 231 232 463
Spain 11 7 18
Ukraine 39 39 78
1.Primary Outcome
Title Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
Hide Description (composite incidence)
Time Frame randomization through 48 hours after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (excluding STEMI)
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg)at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 3889 3865
Measure Type: Number
Unit of Measure: participants
290 276
2.Secondary Outcome
Title Incidence of All-cause Mortality and MI
Hide Description (composite incidence)
Time Frame randomization through 48 hours after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (excluding STEMI)
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 3889 3865
Measure Type: Number
Unit of Measure: participants
285 261
3.Secondary Outcome
Title Individual Incidence of All-cause Mortality
Hide Description [Not Specified]
Time Frame randomization through 48 hours after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (excluding STEMI)
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 3889 3865
Measure Type: Number
Unit of Measure: participants
8 5
4.Secondary Outcome
Title Individual Incidence of IDR
Hide Description [Not Specified]
Time Frame randomization through 48 hours after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (excluding STEMI)
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 3889 3865
Measure Type: Number
Unit of Measure: participants
13 23
5.Secondary Outcome
Title Incidence of Stroke
Hide Description

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.
Time Frame randomization through 48 hours after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (excluding STEMI)
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 3889 3865
Measure Type: Number
Unit of Measure: participants
primary hemorrhagic 1 0
infarction with hemorrhagic conversion 0 0
cerebral infarction 5 7
uncertain type 0 0
6.Secondary Outcome
Title Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI
Hide Description (a patient could have multiple procedural events)
Time Frame during index PCI
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (excluding STEMI) and based on available data
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 3897 3871
Measure Type: Number
Unit of Measure: participants
127 141
7.Secondary Outcome
Title Incidence of All-cause Mortality, MI or IDR
Hide Description (composite incidence)
Time Frame randomization through 30 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (excluding STEMI), based on 30-day completers
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 3860 3827
Measure Type: Number
Unit of Measure: participants
343 327
8.Secondary Outcome
Title Incidence of All-cause Mortality or MI
Hide Description (composite incidence)
Time Frame randomization through 30 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (excluding STEMI), based on 30-day completers
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 3860 3827
Measure Type: Number
Unit of Measure: participants
321 298
9.Secondary Outcome
Title Incidence of All-cause Mortality
Hide Description [Not Specified]
Time Frame randomization through 30 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (excluding STEMI), based on 30-day completers
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 3860 3827
Measure Type: Number
Unit of Measure: participants
34 29
10.Secondary Outcome
Title Incidence of MI
Hide Description [Not Specified]
Time Frame randomization through 30 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (excluding STEMI), based on 30-day completers
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 3860 3827
Measure Type: Number
Unit of Measure: participants
297 276
11.Secondary Outcome
Title Incidence of IDR
Hide Description [Not Specified]
Time Frame randomization through 30 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (excluding STEMI), based on 30-day completers
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 3860 3827
Measure Type: Number
Unit of Measure: participants
44 52
12.Secondary Outcome
Title Incidence of Stroke
Hide Description [Not Specified]
Time Frame randomization through 30 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (excluding STEMI), based on available data
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 3860 3827
Measure Type: Number
Unit of Measure: participants
5 7
13.Secondary Outcome
Title Incidence of All Cause Mortality
Hide Description (excluding STEMI)
Time Frame randomization through 1 year after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (excluding STEMI), based on 1 year completers
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 3851 3818
Measure Type: Number
Unit of Measure: participants
116 120
14.Secondary Outcome
Title Incidence of GUSTO Severe / Life-threatening Bleeding
Hide Description Major bleeding (non-CABG-related) - Safety population
Time Frame randomization through 48 hours after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (inclusive of STEMI patients)
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 4374 4365
Measure Type: Number
Unit of Measure: participants
10 11
15.Secondary Outcome
Title Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Hide Description Major bleeding (non-CABG-related) - Safety population
Time Frame randomization through 48 hours after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (inclusive of STEMI patients)
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 4374 4365
Measure Type: Number
Unit of Measure: participants
19 14
16.Secondary Outcome
Title Incidence of ACUITY Major Bleeding
Hide Description Major bleeding (non-CABG-related) - Safety population
Time Frame randomization through 48 hours after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (inclusive of STEMI patients)
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 4374 4365
Measure Type: Number
Unit of Measure: participants
151 120
17.Secondary Outcome
Title Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)
Hide Description excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm
Time Frame randomization through 48 hours after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (inclusive of STEMI patients)
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description:
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 capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Overall Number of Participants Analyzed 4374 4365
Measure Type: Number
Unit of Measure: participants
78 65
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cangrelor Arm Clopidogrel Arm
Hide Arm/Group Description 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: clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
All-Cause Mortality
Cangrelor Arm Clopidogrel Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cangrelor Arm Clopidogrel Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   125/4374 (2.86%)   127/4365 (2.91%) 
Blood and lymphatic system disorders     
anaemia  1/4374 (0.02%)  0/4365 (0.00%) 
haemolytic anaemia  0/4374 (0.00%)  1/4365 (0.02%) 
haemorrhagic anaemia  0/4374 (0.00%)  2/4365 (0.05%) 
leukocytosis  0/4374 (0.00%)  1/4365 (0.02%) 
thrombocytopenia  0/4374 (0.00%)  2/4365 (0.05%) 
Cardiac disorders     
acute myocardial infarction  1/4374 (0.02%)  0/4365 (0.00%) 
angina pectoris  4/4374 (0.09%)  3/4365 (0.07%) 
arrhythmia  0/4374 (0.00%)  1/4365 (0.02%) 
arrhythmia supraventricular  0/4374 (0.00%)  1/4365 (0.02%) 
arteriospasm coronary  1/4374 (0.02%)  0/4365 (0.00%) 
atrial fibrillation  2/4374 (0.05%)  2/4365 (0.05%) 
atrial flutter  0/4374 (0.00%)  1/4365 (0.02%) 
atrial tachycardia  0/4374 (0.00%)  1/4365 (0.02%) 
atrioventricular block  0/4374 (0.00%)  1/4365 (0.02%) 
atrioventricular block third degree  2/4374 (0.05%)  2/4365 (0.05%) 
bradycardia  2/4374 (0.05%)  3/4365 (0.07%) 
cardiac arrest  4/4374 (0.09%)  6/4365 (0.14%) 
cardiac failure  2/4374 (0.05%)  0/4365 (0.00%) 
cardiac failure acute  1/4374 (0.02%)  1/4365 (0.02%) 
cardiac failure congestive  4/4374 (0.09%)  3/4365 (0.07%) 
cardiac tamponade  1/4374 (0.02%)  0/4365 (0.00%) 
cardiogenic shock  6/4374 (0.14%)  8/4365 (0.18%) 
coronary artery dissection  5/4374 (0.11%)  3/4365 (0.07%) 
coronary artery occlusion  0/4374 (0.00%)  3/4365 (0.07%) 
coronary artery perforation  4/4374 (0.09%)  2/4365 (0.05%) 
coronary artery thrombosis  1/4374 (0.02%)  0/4365 (0.00%) 
in-stent arterial restenosis  0/4374 (0.00%)  1/4365 (0.02%) 
myocardial infarction  0/4374 (0.00%)  1/4365 (0.02%) 
nodal rhythm  1/4374 (0.02%)  0/4365 (0.00%) 
pericardial effusion  1/4374 (0.02%)  0/4365 (0.00%) 
sick sinus syndrome  3/4374 (0.07%)  0/4365 (0.00%) 
sinus arrest  0/4374 (0.00%)  2/4365 (0.05%) 
supraventricular tachycardia  0/4374 (0.00%)  1/4365 (0.02%) 
ventricular arrhythmia  1/4374 (0.02%)  0/4365 (0.00%) 
ventricular asystole  1/4374 (0.02%)  0/4365 (0.00%) 
ventricular fibrillation  12/4374 (0.27%)  6/4365 (0.14%) 
ventricular tachycardia  4/4374 (0.09%)  5/4365 (0.11%) 
Eye disorders     
retinal artery occlusion  1/4374 (0.02%)  0/4365 (0.00%) 
Gastrointestinal disorders     
abdominal pain upper  1/4374 (0.02%)  0/4365 (0.00%) 
haematemesis  0/4374 (0.00%)  1/4365 (0.02%) 
retroperitoneal haemorrhage  1/4374 (0.02%)  0/4365 (0.00%) 
vomiting  0/4374 (0.00%)  2/4365 (0.05%) 
General disorders     
cardiac death  1/4374 (0.02%)  0/4365 (0.00%) 
chest discomfort  0/4374 (0.00%)  1/4365 (0.02%) 
chest pain  7/4374 (0.16%)  9/4365 (0.21%) 
non-cardiac chest pain  2/4374 (0.05%)  1/4365 (0.02%) 
puncture site haemorrhage  0/4374 (0.00%)  1/4365 (0.02%) 
pyrexia  1/4374 (0.02%)  0/4365 (0.00%) 
sudden cardiac death  1/4374 (0.02%)  0/4365 (0.00%) 
sudden death  0/4374 (0.00%)  1/4365 (0.02%) 
vessel puncture site haematoma  1/4374 (0.02%)  0/4365 (0.00%) 
Hepatobiliary disorders     
cholecystitis acute  1/4374 (0.02%)  2/4365 (0.05%) 
gallbladder disorder  0/4374 (0.00%)  1/4365 (0.02%) 
Infections and infestations     
bronchitis  0/4374 (0.00%)  1/4365 (0.02%) 
bronchitis viral  0/4374 (0.00%)  1/4365 (0.02%) 
cellulitis  2/4374 (0.05%)  0/4365 (0.00%) 
haematoma infection  1/4374 (0.02%)  0/4365 (0.00%) 
pneumonia  1/4374 (0.02%)  3/4365 (0.07%) 
sepsis  0/4374 (0.00%)  1/4365 (0.02%) 
urinary tract infection  3/4374 (0.07%)  0/4365 (0.00%) 
Injury, poisoning and procedural complications     
fibula fracture  0/4374 (0.00%)  1/4365 (0.02%) 
thrombosis in device  1/4374 (0.02%)  3/4365 (0.07%) 
vascular procedure complication  0/4374 (0.00%)  1/4365 (0.02%) 
Investigations     
aspartate aminotransferase increased  0/4374 (0.00%)  1/4365 (0.02%) 
cardiac enzymes increased  0/4374 (0.00%)  1/4365 (0.02%) 
liver function test abnormal  1/4374 (0.02%)  0/4365 (0.00%) 
Metabolism and nutrition disorders     
gout  1/4374 (0.02%)  0/4365 (0.00%) 
hypoglycaemia  1/4374 (0.02%)  1/4365 (0.02%) 
Musculoskeletal and connective tissue disorders     
back pain  1/4374 (0.02%)  0/4365 (0.00%) 
musculoskeletal pain  0/4374 (0.00%)  1/4365 (0.02%) 
Nervous system disorders     
cerebral haemorrhage  1/4374 (0.02%)  0/4365 (0.00%) 
diabetic neuropathy  0/4374 (0.00%)  1/4365 (0.02%) 
presyncope  2/4374 (0.05%)  2/4365 (0.05%) 
syncope  1/4374 (0.02%)  1/4365 (0.02%) 
Psychiatric disorders     
alcohol withdrawal syndrome  0/4374 (0.00%)  1/4365 (0.02%) 
depression  1/4374 (0.02%)  0/4365 (0.00%) 
mental status changes  0/4374 (0.00%)  1/4365 (0.02%) 
Renal and urinary disorders     
renal artery stenosis  0/4374 (0.00%)  1/4365 (0.02%) 
renal failure  2/4374 (0.05%)  1/4365 (0.02%) 
renal failure acute  11/4374 (0.25%)  5/4365 (0.11%) 
renal failure chronic  0/4374 (0.00%)  2/4365 (0.05%) 
Respiratory, thoracic and mediastinal disorders     
acute pulmonary oedema  4/4374 (0.09%)  0/4365 (0.00%) 
chronic obstructive pulmonary disease  1/4374 (0.02%)  1/4365 (0.02%) 
dyspnoea  0/4374 (0.00%)  1/4365 (0.02%) 
hypoxia  1/4374 (0.02%)  0/4365 (0.00%) 
pulmonary congestion  0/4374 (0.00%)  1/4365 (0.02%) 
pulmonary embolism  2/4374 (0.05%)  2/4365 (0.05%) 
pulmonary oedema  2/4374 (0.05%)  2/4365 (0.05%) 
respiratory distress  0/4374 (0.00%)  2/4365 (0.05%) 
respiratory failure  3/4374 (0.07%)  2/4365 (0.05%) 
Skin and subcutaneous tissue disorders     
angioneurotic oedema  1/4374 (0.02%)  0/4365 (0.00%) 
Surgical and medical procedures     
stent removal  0/4374 (0.00%)  1/4365 (0.02%) 
Vascular disorders     
arterial thrombosis limb  1/4374 (0.02%)  1/4365 (0.02%) 
artery dissection  0/4374 (0.00%)  1/4365 (0.02%) 
embolism  1/4374 (0.02%)  0/4365 (0.00%) 
femoral artery dissection  0/4374 (0.00%)  1/4365 (0.02%) 
femoral artery occlusion  0/4374 (0.00%)  1/4365 (0.02%) 
haemodynamic instability  0/4374 (0.00%)  1/4365 (0.02%) 
hypertension  0/4374 (0.00%)  1/4365 (0.02%) 
hypertensive emergency  0/4374 (0.00%)  2/4365 (0.05%) 
hypotension  7/4374 (0.16%)  8/4365 (0.18%) 
orthostatic hypotension  1/4374 (0.02%)  0/4365 (0.00%) 
peripheral ischaemia  1/4374 (0.02%)  1/4365 (0.02%) 
reperfusion injury  0/4374 (0.00%)  1/4365 (0.02%) 
shock haemorrhagic  0/4374 (0.00%)  1/4365 (0.02%) 
thrombosis  1/4374 (0.02%)  1/4365 (0.02%) 
vascular pseudoaneurysm  1/4374 (0.02%)  0/4365 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Cangrelor Arm Clopidogrel Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   1149/4374 (26.27%)   1159/4365 (26.55%) 
Cardiac disorders     
ventricular tachycardia  37/4374 (0.85%)  35/4365 (0.80%) 
bradycardia  29/4374 (0.66%)  35/4365 (0.80%) 
atrial fibrillation  27/4374 (0.62%)  18/4365 (0.41%) 
angina pectoris  20/4374 (0.46%)  34/4365 (0.78%) 
Gastrointestinal disorders     
nausea  112/4374 (2.56%)  145/4365 (3.32%) 
vomiting  70/4374 (1.60%)  78/4365 (1.79%) 
dyspepsia  14/4374 (0.32%)  22/4365 (0.50%) 
General disorders     
chest pain  178/4374 (4.07%)  163/4365 (3.73%) 
puncture site pain  67/4374 (1.53%)  52/4365 (1.19%) 
pyrexia  45/4374 (1.03%)  37/4365 (0.85%) 
chest discomfort  32/4374 (0.73%)  24/4365 (0.55%) 
Musculoskeletal and connective tissue disorders     
back pain  167/4374 (3.82%)  164/4365 (3.76%) 
pain in extremity  20/4374 (0.46%)  24/4365 (0.55%) 
musculoskeletal pain  17/4374 (0.39%)  23/4365 (0.53%) 
Nervous system disorders     
headache  93/4374 (2.13%)  97/4365 (2.22%) 
syncope vasovagal  17/4374 (0.39%)  26/4365 (0.60%) 
dizziness  17/4374 (0.39%)  21/4365 (0.48%) 
Psychiatric disorders     
anxiety  16/4374 (0.37%)  22/4365 (0.50%) 
Respiratory, thoracic and mediastinal disorders     
dyspnea  42/4374 (0.96%)  16/4365 (0.37%) 
Vascular disorders     
hypotension  97/4374 (2.22%)  89/4365 (2.04%) 
hypertension  32/4374 (0.73%)  34/4365 (0.78%) 
Discontinued per prespecified stopping rules after the 70% interim analyses was conducted indicating the trial was not likely to meet the goal of demonstrating superiority to clopidogrel administered as usual care. No safety issues were identified.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Meredith Todd
Organization: The Medicines Company
Phone: +19732906088
EMail: meredith.todd@themedco.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00305162     History of Changes
Other Study ID Numbers: TMC-CAN-05-02
First Submitted: March 17, 2006
First Posted: March 21, 2006
Results First Submitted: April 22, 2013
Results First Posted: April 23, 2014
Last Update Posted: May 8, 2014