Cangrelor Prasugrel Transition Study

The Medicines Company

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease

Treatments: Drug: Cangrelor; Drug: Prasugrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01852019

MDCO-CAN-13-01

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

12 participants in 5 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Prasugrel

Drug: Cangrelor

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

Experimental group

Description:

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

Treatment:

Drug: Prasugrel

Drug: Cangrelor

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

Experimental group

Description:

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

Treatment:

Drug: Prasugrel

Drug: Cangrelor

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

Experimental group

Description:

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

Treatment:

Drug: Prasugrel

Drug: Cangrelor

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

Experimental group

Description:

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

Treatment:

Drug: Prasugrel

Drug: Cangrelor