Cangrelor Prasugrel Transition Study

NCT ID: NCT01852019

Last Updated: 2015-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-07-31

Brief Summary

To demonstrate that patients treated with cangrelor can be directly switched to oral prasugrel and that patients treated with prasugrel can be switched to cangrelor without a significant decrease in the extent of inhibition of platelet aggregation.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Day 1 - Cangrelor + Prasugrel (60mg) post infusion

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

Group Type: EXPERIMENTAL

Cangrelor

Intervention Type: DRUG

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

Prasugrel

Intervention Type: DRUG

Day 1: Subjects received 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)

Group Type: EXPERIMENTAL

Cangrelor

Intervention Type: DRUG

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

Prasugrel

Intervention Type: DRUG

Day 1: Subjects received 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.

Group Type: EXPERIMENTAL

Cangrelor

Intervention Type: DRUG

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

Prasugrel

Intervention Type: DRUG

Day 1: Subjects received 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.

Group Type: EXPERIMENTAL

Cangrelor

Intervention Type: DRUG

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

Prasugrel

Intervention Type: DRUG

Day 1: Subjects received 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)

Group Type: EXPERIMENTAL

Cangrelor

Intervention Type: DRUG

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

Prasugrel

Intervention Type: DRUG

Day 1: Subjects received 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.

Interventions

Cangrelor

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

Intervention Type: DRUG

Prasugrel

Day 1: Subjects received 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. greater than / equal to 18 and less than 75 years of age

2. stable coronary artery disease defined by the following criteria

1. Previous myocardial infarction defined by admission to the hospital with elevation of markers of injury or the presence of pathologic Q waves on at least 2 contiguous electrocardiogram (ECG) leads.

OR

2. Previous revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG).

AND

3. Treatment with aspirin (ASA) 81 mg daily.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Medicines Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J. Schneider

Role: PRINCIPAL_INVESTIGATOR

University of Vermont Medical Center

Locations

Fletcher Allen Health Care

Burlington, Vermont, United States

Countries

United States

Other Identifiers

MDCO-CAN-13-01

Identifier Type: -

Identifier Source: org_study_id