Maintenance of Platelet Inhibition With Cangrelor (Bridge)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00767507
First received: October 6, 2008
Last updated: February 21, 2014
Last verified: February 2014
Results First Received: April 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute Coronary Syndrome (ACS)
Interventions: Drug: cangrelor
Other: Placebo

  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
This study enrolled patients with acute coronary syndrome (ACS) or who had previously received stents, who were required to discontinue maintenance oral P2Y12 therapy before cardiac surgery. Patients who had discontinued oral therapy within the previous 72 hours were eligible. Patients were hospitalized during the enrollment period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Stage I was an open-label, dose-finding stage to identify the dose of cangrelor that achieved a level of antiplatelet effect after discontinuation of oral P2Y12 therapy equivalent to the previous oral P2Y12 maintenance therapy. These patients were not enrolled in Stage II.

Stage II was randomized, double-blind, placebo-controlled.


Reporting Groups
  Description
Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
Stage II - Cangrelor Arm (0.75 mcg/kg/Min ) Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
Stage II - Placebo Arm Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.

Participant Flow:   Overall Study
    Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor     Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor     Stage II - Cangrelor Arm (0.75 mcg/kg/Min )     Stage II - Placebo Arm  
STARTED     5     6     106     104  
COMPLETED     5     6     106     101  
NOT COMPLETED     0     0     0     3  



  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.
This is the Safety Population: Includs both Stage I and Stage II patients who received any study drug and were classified according to the actual treatment received. Stage I (open-label) patients were analyzed based on the dose they received; Stage II (randomized) patients were analyzed based on the actual treatment, cangrelor or placebo, received.

Reporting Groups
  Description
Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
Stage II Cangrelor Arm (0.75 mcg/kg/Min) Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
Stage II Placebo Arm Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
Total Total of all reporting groups

Baseline Measures
    Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor     Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor     Stage II Cangrelor Arm (0.75 mcg/kg/Min)     Stage II Placebo Arm     Total  
Number of Participants  
[units: participants]
  5     6     106     101     218  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     3     3     52     59     117  
>=65 years     2     3     54     42     101  
Gender  
[units: participants]
         
Female     0     2     26     27     55  
Male     5     4     80     74     163  
Region of Enrollment [1]
[units: participants]
         
United States     5     6     66     59     136  
Netherlands     0     0     5     6     11  
Czech Republic     0     0     26     29     55  
United Kingdom     0     0     8     4     12  
Austria     0     0     1     6     7  
[1] This population in Region of Enrollment, represents the total number of subjects enrolled/randomized, and does not exclude any patients. Therefore there are more patients represented here versus in the Safety Population.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay.   [ Time Frame: During study drug infusion up to 1-6 hours prior to surgery ]

2.  Primary:   Stage II: The Percentage of Patients That Maintained Platelet Reaction Units (PRU) < 240, as Determined by the VerifyNow P2Y12 Point of Care Assay, Measured During Study Drug Infusion Pre-surgery.   [ Time Frame: During study drug infusion up to 1-6 hours prior to surgery ]

3.  Secondary:   Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU   [ Time Frame: baseline until just prior to surgery (post infusion) ]

4.  Secondary:   Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding   [ Time Frame: Randomization through Hospital discharge ]

5.  Secondary:   Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild   [ Time Frame: Randomization until start of CABG surgery ]

6.  Secondary:   Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner   [ Time Frame: Through 7 days or hospital discharge, whichever was sooner ]


  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
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  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 - Sr. Director Program Management
Organization: The Medicines Company
phone: +1.973.290.6088
e-mail: meredith.todd@themedco.com


No publications provided by The Medicines Company

Publications automatically indexed to this study:

Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00767507     History of Changes
Other Study ID Numbers: TMC-CAN-08-02
Study First Received: October 6, 2008
Results First Received: April 23, 2013
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration