Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 27 for:    cangrelor

Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition. (Platform)

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: NCT00385138
Recruitment Status : Terminated (Insufficient evidence of the clinical effectiveness of cangrelor)
First Posted : October 6, 2006
Results First Posted : April 21, 2014
Last Update Posted : May 5, 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 Atherosclerosis
Acute Coronary Syndrome (ACS)
Interventions Drug: Cangrelor
Drug: clopidogrel
Drug: Placebo bolus & placebo infusion
Drug: Placebo capsules - end of PCI
Drug: Placebo capsules - end of infusion
Enrollment 5364
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 confirm by angiography.

Pre-assignment Details  
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description 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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Period Title: Overall Study
Started 2695 2669
Intent-to-treat (ITT) 2693 [1] 2669
Modified Intent-to-treat (mITT) 2656 [2] 2645 [3]
Safety Population 2662 [4] 2650 [4]
Completed 2665 [5] 2641 [5]
Not Completed 30 28
[1]
All patients randomized excluding two (2) who withdrew consent for using study data.
[2]
Excludes 37 patients who either did not receive study drug or have PCI.
[3]
Excludes 24 patients who either did not received study drug or have PCI.
[4]
Includes all randomized patients who received at least one dose of study drug.
[5]
"Completed" means patient completed scheduled visits or developed a primary endpoint event.
Arm/Group Title Cangrelor Clopidogrel Total
Hide Arm/Group Description 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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion Total of all reporting groups
Overall Number of Baseline Participants 2656 2645 5301
Hide Baseline Analysis Population Description
mITT population
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2656 participants 2645 participants 5301 participants
62.5  (11.4) 62.5  (11.3) 62.5  (11.4)
[1]
Measure Description: mITT population
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2656 participants 2645 participants 5301 participants
Female
747
  28.1%
782
  29.6%
1529
  28.8%
Male
1909
  71.9%
1863
  70.4%
3772
  71.2%
[1]
Measure Description: mITT population
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2656 participants 2645 participants 5301 participants
United States 815 809 1624
Argentina 39 42 81
Brazil 48 49 97
Bulgaria 403 394 797
Canada 3 2 5
Czech Republic 342 345 687
Georgia 47 43 90
India 235 236 471
Lithuania 54 55 109
New Zealand 22 20 42
Belarus 33 31 64
Russian Federation 215 218 433
Slovakia 33 27 60
South Africa 102 100 202
Korea, Republic of 159 166 325
Spain 17 21 38
Thailand 58 58 116
Netherlands 31 29 60
[1]
Measure Description: The analysis by region was performed on the mITT population.
1.Primary Outcome
Title Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
Hide Description mITT population; (composite incidence)
Time Frame randomization through 48 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2654 2641
Measure Type: Number
Unit of Measure: participants
185 210
2.Secondary Outcome
Title Incidence of All-cause Mortality or MI
Hide Description mITT population
Time Frame randomization through 48 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2654 2641
Measure Type: Number
Unit of Measure: participants
180 204
3.Secondary Outcome
Title Incidence of All-cause Mortality
Hide Description mITT population
Time Frame randomization through 48 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2654 2641
Measure Type: Number
Unit of Measure: participants
6 18
4.Secondary Outcome
Title Incidence of MI
Hide Description mITT population
Time Frame randomization through 48 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2654 2641
Measure Type: Number
Unit of Measure: participants
177 191
5.Secondary Outcome
Title Incidence of IDR
Hide Description mITT population
Time Frame randomization through 48 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2654 2641
Measure Type: Number
Unit of Measure: participants
19 24
6.Secondary Outcome
Title Incidence of Stent Thrombosis
Hide Description mITT population
Time Frame randomization through 48 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2654 2641
Measure Type: Number
Unit of Measure: participants
5 16
7.Secondary Outcome
Title Incidence of Stroke
Hide Description mITT
Time Frame randomization through 48 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2654 2641
Measure Type: Number
Unit of Measure: participants
7 5
8.Secondary Outcome
Title Incidence of All-cause Mortality
Hide Description mITT population
Time Frame randomization through 1 year post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2628 2618
Measure Type: Number
Unit of Measure: participants
94 113
9.Secondary Outcome
Title Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis]
Hide Description mITT population A patient could have multiple procedural events.
Time Frame During index PCI
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2656 2645
Measure Type: Number
Unit of Measure: participants
122 142
10.Secondary Outcome
Title Incidence of GUSTO Severe / Life-threatening
Hide Description Major bleeding (non-CABG-related) - Safety population
Time Frame randomization through 48 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2662 2650
Measure Type: Number
Unit of Measure: participants
9 6
11.Secondary Outcome
Title Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major
Hide Description Major bleeding (non-CABG-related) - Safety population
Time Frame randomization through 48 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2662 2650
Measure Type: Number
Unit of Measure: participants
4 9
12.Secondary Outcome
Title Incidence of ACUITY Major Bleeding
Hide Description Major bleeding (non-CABG-related) - Safety population
Time Frame randomization through 48 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2662 2650
Measure Type: Number
Unit of Measure: participants
145 91
13.Secondary Outcome
Title Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm
Hide Description Major bleeding (non-CABG-related) - Safety population excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm.
Time Frame randomization through 48 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2662 2650
Measure Type: Number
Unit of Measure: participants
43 29
14.Secondary Outcome
Title Incidence of All-cause Mortality, MI, or IDR
Hide Description mITT population
Time Frame randomization through 30 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2647 2629
Measure Type: Number
Unit of Measure: participants
227 249
15.Secondary Outcome
Title Incidence of All-cause Mortality or MI
Hide Description mITT population
Time Frame randomization through 30 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2647 2629
Measure Type: Number
Unit of Measure: participants
213 233
16.Secondary Outcome
Title Incidence of All-cause Mortality
Hide Description mITT population
Time Frame randomization through 30 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2647 2629
Measure Type: Number
Unit of Measure: participants
35 45
17.Secondary Outcome
Title Incidence of MI
Hide Description mITT population
Time Frame randomization through 30 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2647 2629
Measure Type: Number
Unit of Measure: participants
189 201
18.Secondary Outcome
Title Incidence of IDR
Hide Description mITT population
Time Frame randomization through 30 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2647 2629
Measure Type: Number
Unit of Measure: participants
37 46
19.Secondary Outcome
Title Incidence of Stent Thrombosis
Hide Description mITT population
Time Frame randomization through 30 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2647 2629
Measure Type: Number
Unit of Measure: participants
15 28
20.Secondary Outcome
Title Incidence of Stroke
Hide Description mITT population
Time Frame randomization through 30 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population, based on available data
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description:
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Overall Number of Participants Analyzed 2647 2629
Measure Type: Number
Unit of Measure: participants
6 5
Time Frame Adverse events were collected through 48 hours after study drug initiation
Adverse Event Reporting Description The analysis population used for adverse event reporting is the Safety Population.
 
Arm/Group Title Cangrelor Clopidogrel
Hide Arm/Group Description 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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
All-Cause Mortality
Cangrelor Clopidogrel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cangrelor Clopidogrel
Affected / at Risk (%) Affected / at Risk (%)
Total   48/2662 (1.80%)   55/2650 (2.08%) 
Cardiac disorders     
atrial fibrillation  2/2662 (0.08%)  1/2650 (0.04%) 
atrioventricular block  0/2662 (0.00%)  1/2650 (0.04%) 
cardiac arrest  1/2662 (0.04%)  3/2650 (0.11%) 
cardiac failure acute  1/2662 (0.04%)  0/2650 (0.00%) 
cardiac failure congestive  3/2662 (0.11%)  1/2650 (0.04%) 
cardiac tamponade  0/2662 (0.00%)  1/2650 (0.04%) 
cardiogenic shock  6/2662 (0.23%)  11/2650 (0.42%) 
coronary artery dissection  0/2662 (0.00%)  2/2650 (0.08%) 
coronary artery occlusion  0/2662 (0.00%)  1/2650 (0.04%) 
coronary artery perforation  1/2662 (0.04%)  0/2650 (0.00%) 
coronary artery thrombosis  0/2662 (0.00%)  1/2650 (0.04%) 
electromechanical dissociation  1/2662 (0.04%)  3/2650 (0.11%) 
ischaemic cardiomyopathy  0/2662 (0.00%)  1/2650 (0.04%) 
left ventricular failure  0/2662 (0.00%)  1/2650 (0.04%) 
myocardial infarction  1/2662 (0.04%)  0/2650 (0.00%) 
myocardial rupture  0/2662 (0.00%)  1/2650 (0.04%) 
pericardial effusion  1/2662 (0.04%)  0/2650 (0.00%) 
sick sinus syndrome  1/2662 (0.04%)  0/2650 (0.00%) 
torsade de pointes  0/2662 (0.00%)  2/2650 (0.08%) 
ventricular arrhythmia  1/2662 (0.04%)  0/2650 (0.00%) 
ventricular fibrillation  4/2662 (0.15%)  2/2650 (0.08%) 
ventricular tachycardia  1/2662 (0.04%)  1/2650 (0.04%) 
Gastrointestinal disorders     
Barrett's oesophagus  0/2662 (0.00%)  1/2650 (0.04%) 
retroperitoneal haemorrhage  1/2662 (0.04%)  0/2650 (0.00%) 
General disorders     
chest discomfort  1/2662 (0.04%)  1/2650 (0.04%) 
chest pain  2/2662 (0.08%)  1/2650 (0.04%) 
non-cardiac chest pain  1/2662 (0.04%)  0/2650 (0.00%) 
pyrexia  2/2662 (0.08%)  0/2650 (0.00%) 
Infections and infestations     
bacterial sepsis  0/2662 (0.00%)  1/2650 (0.04%) 
lung infection  0/2662 (0.00%)  1/2650 (0.04%) 
Injury, poisoning and procedural complications     
arterial injury  0/2662 (0.00%)  1/2650 (0.04%) 
brain contusion  1/2662 (0.04%)  0/2650 (0.00%) 
head injury  1/2662 (0.04%)  0/2650 (0.00%) 
thrombosis in device  0/2662 (0.00%)  2/2650 (0.08%) 
Investigations     
anticoagulation drug level below therapeutic  1/2662 (0.04%)  0/2650 (0.00%) 
cardiac enzymes increased  1/2662 (0.04%)  0/2650 (0.00%) 
troponin increased  0/2662 (0.00%)  1/2650 (0.04%) 
Nervous system disorders     
dizziness  1/2662 (0.04%)  0/2650 (0.00%) 
dizziness postural  0/2662 (0.00%)  1/2650 (0.04%) 
haemorrhage intracranial  1/2662 (0.04%)  0/2650 (0.00%) 
migraine  1/2662 (0.04%)  0/2650 (0.00%) 
myelitis  0/2662 (0.00%)  1/2650 (0.04%) 
transient ischaemic attack  0/2662 (0.00%)  2/2650 (0.08%) 
Renal and urinary disorders     
nephropathy toxic  2/2662 (0.08%)  0/2650 (0.00%) 
renal failure chronic  1/2662 (0.04%)  0/2650 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
acute pulmonary oedema  3/2662 (0.11%)  0/2650 (0.00%) 
atelectasis  0/2662 (0.00%)  1/2650 (0.04%) 
dyspnoea  1/2662 (0.04%)  0/2650 (0.00%) 
pulmonary embolism  0/2662 (0.00%)  1/2650 (0.04%) 
pulmonary oedema  2/2662 (0.08%)  4/2650 (0.15%) 
respiratory failure  1/2662 (0.04%)  0/2650 (0.00%) 
Skin and subcutaneous tissue disorders     
angioneurotic oedema  1/2662 (0.04%)  0/2650 (0.00%) 
Vascular disorders     
hypertension  1/2662 (0.04%)  2/2650 (0.08%) 
hypertensive emergency  1/2662 (0.04%)  0/2650 (0.00%) 
hypotension  1/2662 (0.04%)  4/2650 (0.15%) 
peripheral ischaemia  0/2662 (0.00%)  1/2650 (0.04%) 
vascular pseudoaneurysm  0/2662 (0.00%)  1/2650 (0.04%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Cangrelor Clopidogrel
Affected / at Risk (%) Affected / at Risk (%)
Total   596/2662 (22.39%)   530/2650 (20.00%) 
Cardiac disorders     
angina pectoris  11/2662 (0.41%)  17/2650 (0.64%) 
bradycardia  10/2662 (0.38%)  15/2650 (0.57%) 
Gastrointestinal disorders     
nausea  71/2662 (2.67%)  66/2650 (2.49%) 
vomiting  37/2662 (1.39%)  31/2650 (1.17%) 
General disorders     
chest pain  73/2662 (2.74%)  69/2650 (2.60%) 
pyrexia  36/2662 (1.35%)  20/2650 (0.75%) 
puncture site pain  21/2662 (0.79%)  29/2650 (1.09%) 
pain  14/2662 (0.53%)  8/2650 (0.30%) 
chest discomfort  13/2662 (0.49%)  11/2650 (0.42%) 
Musculoskeletal and connective tissue disorders     
back pain  91/2662 (3.42%)  85/2650 (3.21%) 
pain in extremity  14/2662 (0.53%)  14/2650 (0.53%) 
Nervous system disorders     
headache  60/2662 (2.25%)  68/2650 (2.57%) 
syncope vasovagal  13/2662 (0.49%)  4/2650 (0.15%) 
Psychiatric disorders     
anxiety  13/2662 (0.49%)  3/2650 (0.11%) 
insomnia  10/2662 (0.38%)  15/2650 (0.57%) 
Respiratory, thoracic and mediastinal disorders     
dyspnea  38/2662 (1.43%)  15/2650 (0.57%) 
Vascular disorders     
hypotension  43/2662 (1.62%)  38/2650 (1.43%) 
hypertension  28/2662 (1.05%)  22/2650 (0.83%) 
Discontinued per prespecified stopping rules after the 70% interim analyses was conducted indicating the trial was not likely not 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: 973.290.6088
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: NCT00385138     History of Changes
Other Study ID Numbers: TMC-CAN-05-03
First Submitted: October 4, 2006
First Posted: October 6, 2006
Results First Submitted: April 22, 2013
Results First Posted: April 21, 2014
Last Update Posted: May 5, 2014