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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  
Number of Participants  
[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:

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