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Trial record 20 of 27 for:    cangrelor

A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX) (CHAMPION)

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: NCT01156571
Recruitment Status : Completed
First Posted : July 5, 2010
Results First Posted : June 18, 2013
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Atherosclerosis
Percutaneous Coronary Intervention
Acute Coronary Syndrome
Interventions Drug: cangrelor P2Y12 (platelet) inhibitor
Drug: Clopidogrel - 300 or 600 mg (study arm)
Drug: Clopidogrel 600 mg post cangrelor
Enrollment 11145
Recruitment Details

Date first patient enrolled: 30 Sep 2010 Date last patient completed: 14 Nov 2012

This trial enrolled the full spectrum of patients who required PCI (SA, NSTE-ACS, STEMI). Randomization occurred after confirmation of need for PCI (after diagnostic angiogram in all cases, except for STEMI patients). Patients were followed through 30-days.

Pre-assignment Details Due to the nature of the disease, STEMI patients were permitted to be randomized upon ECG confirmation and prior to confirmation of need for PCI (prior to diagnostic angiography). Therefore in some cases, STEMI patients did not require PCI and therefore did not receive all study drug.
Arm/Group Title Cangrelor Treatment Arm Clopidogrel Treatment Arm
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Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.

Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.

Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose.

Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.

Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.

At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose.

Period Title: Overall Study
Started 5581 [1] 5564 [1]
Completed 5564 [2] 5545 [2]
Not Completed 17 19
[1]
ITT: defined as all patients randomized.
[2]
Completed = ITT patients who completed scheduled visits or developed a primary endpoint event
Arm/Group Title Cangrelor Treatment Arm Clopidogrel Treatment Arm Total
Hide Arm/Group Description

Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.

Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.

Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose.

Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.

Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.

At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose.

Total of all reporting groups
Overall Number of Baseline Participants 5581 5564 11145
Hide Baseline Analysis Population Description
ITT population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5581 participants 5564 participants 11145 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2892
  51.8%
2902
  52.2%
5794
  52.0%
>=65 years
2689
  48.2%
2662
  47.8%
5351
  48.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5581 participants 5564 participants 11145 participants
64.0  (11.0) 63.8  (11.0) 63.9  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5581 participants 5564 participants 11145 participants
Female
1599
  28.7%
1522
  27.4%
3121
  28.0%
Male
3982
  71.3%
4042
  72.6%
8024
  72.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5581 participants 5564 participants 11145 participants
United States 2099 2089 4188
Austria 302 300 602
Brazil 78 80 158
Bulgaria 169 167 336
Czech Republic 814 816 1630
Georgia 744 741 1485
Germany 243 251 494
Italy 311 310 621
New Zealand 22 23 45
Poland 352 350 702
Russian Federation 296 286 582
Thailand 151 151 302
1.Primary Outcome
Title The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)
Hide Description Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population)
Time Frame 48 hours after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cangrelor Treatment Arm Clopidogrel Treatment Arm
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 5470 5469
Measure Type: Number
Unit of Measure: participants
257 322
2.Secondary Outcome
Title Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)
Hide Description CEC-adjudicated results (mITT population)
Time Frame 48 hours after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cangrelor Treatment Arm Clopidogrel Treatment Arm
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 5470 5469
Measure Type: Number
Unit of Measure: participants
Stent Thrombosis 46 74
Death 18 18
MI (myocardial infarction) 207 255
IDR (ischemia-driven revascularization) 28 38
3.Secondary Outcome
Title Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild
Hide Description GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial
Time Frame 48 hours after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cangrelor Treatment Arm Clopidogrel Treatment Arm
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 5529 5527
Measure Type: Number
Unit of Measure: participants
GUSTO severe/life threatening 9 6
GUSTO moderate 22 13
GUSTO severe or moderate 31 19
TIMI major 5 5
TIMI minor 9 3
TIMI major or minor 14 8
Any blood transfusion 25 16
Time Frame AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cangrelor Treatment Arm Clopidogrel Treatment Arm
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Cangrelor Treatment Arm Clopidogrel Treatment Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cangrelor Treatment Arm Clopidogrel Treatment Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   122/5529 (2.21%)   105/5527 (1.90%) 
Blood and lymphatic system disorders     
Anaemia  1/5529 (0.02%)  0/5527 (0.00%) 
Hypersplenism  0/5529 (0.00%)  1/5527 (0.02%) 
Pancytopenia  0/5529 (0.00%)  1/5527 (0.02%) 
Cardiac disorders     
acute coronary syndrome  1/5529 (0.02%)  0/5527 (0.00%) 
acute myocardial infarction  2/5529 (0.04%)  3/5527 (0.05%) 
angina pectoris  1/5529 (0.02%)  1/5527 (0.02%) 
angina unstable  2/5529 (0.04%)  1/5527 (0.02%) 
Arteriospasm coronary  1/5529 (0.02%)  0/5527 (0.00%) 
atrial fibrillation  2/5529 (0.04%)  2/5527 (0.04%) 
atrioventricular block complete  3/5529 (0.05%)  3/5527 (0.05%) 
bradycardia  1/5529 (0.02%)  1/5527 (0.02%) 
cardiac arrest  5/5529 (0.09%)  8/5527 (0.14%) 
cardiac failure  1/5529 (0.02%)  3/5527 (0.05%) 
cardiac failure acute  1/5529 (0.02%)  0/5527 (0.00%) 
cardiac failure congestive  3/5529 (0.05%)  3/5527 (0.05%) 
cardiac tamponade  1/5529 (0.02%)  0/5527 (0.00%) 
cardio-respiratory arrest  3/5529 (0.05%)  1/5527 (0.02%) 
cardiogenic shock  12/5529 (0.22%)  6/5527 (0.11%) 
coronary artery disease  0/5529 (0.00%)  1/5527 (0.02%) 
coronary artery dissection  9/5529 (0.16%)  6/5527 (0.11%) 
coronary artery occlusion  0/5529 (0.00%)  4/5527 (0.07%) 
coronary artery performation  3/5529 (0.05%)  3/5527 (0.05%) 
Interventricluar septum rupture  2/5529 (0.04%)  0/5527 (0.00%) 
myocardial infarction  2/5529 (0.04%)  1/5527 (0.02%) 
mycardial rupture  0/5529 (0.00%)  3/5527 (0.05%) 
nodal arrhythmia  1/5529 (0.02%)  1/5527 (0.02%) 
percarditis  0/5529 (0.00%)  1/5527 (0.02%) 
sick sinus syndrome  1/5529 (0.02%)  1/5527 (0.02%) 
sinus arrest  1/5529 (0.02%)  0/5527 (0.00%) 
ventricular rupture  1/5529 (0.02%)  0/5527 (0.00%) 
ventricular asystole  0/5529 (0.00%)  1/5527 (0.02%) 
ventricular fibrillation  6/5529 (0.11%)  7/5527 (0.13%) 
ventricluar tachycardia  5/5529 (0.09%)  3/5527 (0.05%) 
Gastrointestinal disorders     
gastroesophageal reflux disease  0/5529 (0.00%)  1/5527 (0.02%) 
General disorders     
chest discomfort  1/5529 (0.02%)  0/5527 (0.00%) 
chest pain  5/5529 (0.09%)  2/5527 (0.04%) 
non-cardiac chest pain  2/5529 (0.04%)  0/5527 (0.00%) 
pyrexia  0/5529 (0.00%)  1/5527 (0.02%) 
thrombosis in device  3/5529 (0.05%)  3/5527 (0.05%) 
Hepatobiliary disorders     
hepatic cirrhosis  0/5529 (0.00%)  1/5527 (0.02%) 
Immune system disorders     
anaphylactic reaction  2/5529 (0.04%)  0/5527 (0.00%) 
anaphylactic shock  1/5529 (0.02%)  0/5527 (0.00%) 
hypersensitivity  0/5529 (0.00%)  2/5527 (0.04%) 
Infections and infestations     
bronchitis  1/5529 (0.02%)  0/5527 (0.00%) 
pneumonia  1/5529 (0.02%)  1/5527 (0.02%) 
septic shock  1/5529 (0.02%)  0/5527 (0.00%) 
small intestine gangrene  1/5529 (0.02%)  0/5527 (0.00%) 
urinary tract infection  0/5529 (0.00%)  1/5527 (0.02%) 
Injury, poisoning and procedural complications     
cardiac procedure complication  0/5529 (0.00%)  1/5527 (0.02%) 
fall  0/5529 (0.00%)  1/5527 (0.02%) 
head injury  0/5529 (0.00%)  1/5527 (0.02%) 
medication error  1/5529 (0.02%)  0/5527 (0.00%) 
postoperative ileus  1/5529 (0.02%)  0/5527 (0.00%) 
subdural haematoma  0/5529 (0.00%)  1/5527 (0.02%) 
vascular pseudoaneurysm  1/5529 (0.02%)  0/5527 (0.00%) 
Investigations     
blood creatinine increased  3/5529 (0.05%)  1/5527 (0.02%) 
electrocardiogram ST segment elevation  0/5529 (0.00%)  1/5527 (0.02%) 
troponin increased  1/5529 (0.02%)  2/5527 (0.04%) 
Metabolism and nutrition disorders     
diabetes mellitus  1/5529 (0.02%)  0/5527 (0.00%) 
fluid overload  0/5529 (0.00%)  1/5527 (0.02%) 
Musculoskeletal and connective tissue disorders     
compartment syndrome  1/5529 (0.02%)  0/5527 (0.00%) 
neck pain  0/5529 (0.00%)  1/5527 (0.02%) 
Nervous system disorders     
cerebrovascular accident  0/5529 (0.00%)  2/5527 (0.04%) 
embolic cerebral infarction  0/5529 (0.00%)  1/5527 (0.02%) 
ischaemic stroke  2/5529 (0.04%)  1/5527 (0.02%) 
lethargy  0/5529 (0.00%)  1/5527 (0.02%) 
migraine  1/5529 (0.02%)  0/5527 (0.00%) 
presyncope  1/5529 (0.02%)  3/5527 (0.05%) 
transient ischaemic attack  1/5529 (0.02%)  1/5527 (0.02%) 
Psychiatric disorders     
delirium  1/5529 (0.02%)  1/5527 (0.02%) 
mental status changes  0/5529 (0.00%)  3/5527 (0.05%) 
Renal and urinary disorders     
nephrolithiasis  1/5529 (0.02%)  0/5527 (0.00%) 
nephropathy toxic  1/5529 (0.02%)  2/5527 (0.04%) 
renal failure  2/5529 (0.04%)  1/5527 (0.02%) 
renal failure acute  2/5529 (0.04%)  2/5527 (0.04%) 
renal impairment  1/5529 (0.02%)  0/5527 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
aspiration  1/5529 (0.02%)  0/5527 (0.00%) 
chronic obstructive pulmonary disease  0/5529 (0.00%)  1/5527 (0.02%) 
dyspnoea  1/5529 (0.02%)  0/5527 (0.00%) 
dyspnoea exertional  1/5529 (0.02%)  0/5527 (0.00%) 
pulmonary embolism  2/5529 (0.04%)  0/5527 (0.00%) 
pulmonary oedema  6/5529 (0.11%)  3/5527 (0.05%) 
respiratory failure  2/5529 (0.04%)  0/5527 (0.00%) 
Vascular disorders     
aortic dissection  1/5529 (0.02%)  0/5527 (0.00%) 
arterial rupture  2/5529 (0.04%)  2/5527 (0.04%) 
circulatory collapse  0/5529 (0.00%)  1/5527 (0.02%) 
deep vein thrombosis  1/5529 (0.02%)  0/5527 (0.00%) 
hypertension  0/5529 (0.00%)  1/5527 (0.02%) 
hypotension  7/5529 (0.13%)  3/5527 (0.05%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cangrelor Treatment Arm Clopidogrel Treatment Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5529 (0.00%)   0/5527 (0.00%) 
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.

In general, 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 45 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 - Sr. Director Program Management
Organization: The Medicines Company
Phone: +1.973.290.6088
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: NCT01156571     History of Changes
Other Study ID Numbers: TMC-CAN-10-01
First Submitted: June 29, 2010
First Posted: July 5, 2010
Results First Submitted: April 22, 2013
Results First Posted: June 18, 2013
Last Update Posted: February 4, 2014