Cangrelor Prasugrel Transition Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT01852019
First received: May 6, 2013
Last updated: May 27, 2015
Last verified: May 2015
Results First Received: August 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Coronary Artery Disease
Interventions: Drug: Cangrelor
Drug: Prasugrel

  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
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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
Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion

Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation

cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h

Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time.

cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h

Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time.

cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Day 8 - Prasugrel (10mg) Dosing (5 Doses)

Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h)

cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Day 8 - Prasugrel (10mg) Dosing (6 Doses)

Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)

cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.


Participant Flow for 2 periods

Period 1:   Day 1
    Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion     Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h     Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h     Day 8 - Prasugrel (10mg) Dosing (5 Doses)     Day 8 - Prasugrel (10mg) Dosing (6 Doses)  
STARTED     3     3     6     0     0  
COMPLETED     3     3     6     0     0  
NOT COMPLETED     0     0     0     0     0  

Period 2:   Day 8
    Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion     Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h     Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h     Day 8 - Prasugrel (10mg) Dosing (5 Doses)     Day 8 - Prasugrel (10mg) Dosing (6 Doses)  
STARTED     0     0     0     6     6  
COMPLETED     0     0     0     6     6  
NOT COMPLETED     0     0     0     0     0  



  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
Day 8 - Prasugrel (10mg) Dosing (6 Doses)

Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)

Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Day 8 - Prasugrel (10mg) Dosing (5 Doses)

Prasugrel discontinued 48h prior to initiation of cangrelor infusion (2h)

Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8

Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Total Total of all reporting groups

Baseline Measures
    Day 8 - Prasugrel (10mg) Dosing (6 Doses)     Day 8 - Prasugrel (10mg) Dosing (5 Doses)     Total  
Number of Participants  
[units: participants]
  6     6     12  
Age  
[units: years]
Mean (Standard Deviation)
  62.3  (6.47)     67.3  (4.37)     64.8  (5.87)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     6     6     12  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     6     6     12  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     6     6     12  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     6     6     12  



  Outcome Measures
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1.  Primary:   Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)   [ Time Frame: Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures. ]

2.  Primary:   Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone   [ Time Frame: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion ]

3.  Secondary:   Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)   [ Time Frame: Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures. ]

4.  Secondary:   Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone   [ Time Frame: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion ]

5.  Secondary:   Bleeding Events in Accordance With the GUSTO Scale   [ Time Frame: Day 1 through Day 8 ]


  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: Jayne Prats, PhD - VP, Global Knowledge Management
Organization: The Medicines Company
phone: 888-779-MDCO ext 1510
e-mail: jayne.prats@themedco.com


No publications provided


Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01852019     History of Changes
Other Study ID Numbers: MDCO-CAN-13-01
Study First Received: May 6, 2013
Results First Received: August 1, 2014
Last Updated: May 27, 2015
Health Authority: United States: Food and Drug Administration