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

This study has been terminated.
(Insufficient evidence of the clinical effectiveness of cangrelor)
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00305162
First received: March 17, 2006
Last updated: April 22, 2014
Last verified: April 2014
Results First Received: April 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow for 3 periods

Period 1:   48 Hour Follow-up Period
    Cangrelor Arm   Clopidogrel Arm
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 2:   30-day Follow-up Period
    Cangrelor Arm   Clopidogrel Arm
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 3:   1 Year Follow-up Period
    Cangrelor Arm   Clopidogrel Arm
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) population

Reporting Groups
  Description
Cangrelor Arm 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 arm: clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
Total Total of all reporting groups

Baseline Measures
   Cangrelor Arm   Clopidogrel Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 4433   4444   8877 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.2  (11.3)   62.2  (11.5)   62.2  (11.4) 
Gender 
[Units: Participants]
     
Female   1158   1235   2393 
Male   3275   3209   6484 
Region of Enrollment 
[Units: 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 


  Outcome Measures
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1.  Primary:   Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)   [ Time Frame: randomization through 48 hours after randomization ]

2.  Secondary:   Incidence of All-cause Mortality and MI   [ Time Frame: randomization through 48 hours after randomization ]

3.  Secondary:   Individual Incidence of All-cause Mortality   [ Time Frame: randomization through 48 hours after randomization ]

4.  Secondary:   Individual Incidence of IDR   [ Time Frame: randomization through 48 hours after randomization ]

5.  Secondary:   Incidence of Stroke   [ Time Frame: randomization through 48 hours after randomization ]

6.  Secondary:   Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI   [ Time Frame: during index PCI ]

7.  Secondary:   Incidence of All-cause Mortality, MI or IDR   [ Time Frame: randomization through 30 days after randomization ]

8.  Secondary:   Incidence of All-cause Mortality or MI   [ Time Frame: randomization through 30 days after randomization ]

9.  Secondary:   Incidence of All-cause Mortality   [ Time Frame: randomization through 30 days after randomization ]

10.  Secondary:   Incidence of MI   [ Time Frame: randomization through 30 days after randomization ]

11.  Secondary:   Incidence of IDR   [ Time Frame: randomization through 30 days after randomization ]

12.  Secondary:   Incidence of Stroke   [ Time Frame: randomization through 30 days after randomization ]

13.  Secondary:   Incidence of All Cause Mortality   [ Time Frame: randomization through 1 year after randomization ]

14.  Secondary:   Incidence of GUSTO Severe / Life-threatening Bleeding   [ Time Frame: randomization through 48 hours after randomization ]

15.  Secondary:   Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding   [ Time Frame: randomization through 48 hours after randomization ]

16.  Secondary:   Incidence of ACUITY Major Bleeding   [ Time Frame: randomization through 48 hours after randomization ]

17.  Secondary:   Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)   [ Time Frame: randomization through 48 hours after randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Meredith Todd
Organization: The Medicines Company
phone: +19732906088
e-mail: meredith.todd@themedco.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00305162     History of Changes
Other Study ID Numbers: TMC-CAN-05-02
Study First Received: March 17, 2006
Results First Received: April 22, 2013
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration