Cangrelor Ticagrelor Transition Study

The Medicines Company

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease

Treatments: Drug: Ticagrelor; Drug: cangrelor

Study type: Interventional

Funder types: Industry

Identifiers

NCT01766466

MDCO-CAN-12-03

Details and patient eligibility

About

To demonstrate that patients treated with cangrelor can be directly switched to oral ticagrelor and that patients treated with ticagrelor 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:

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

  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) surgery.

     AND

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

     Exclusion Criteria:

Trial design

12 participants in 4 patient groups

Cangrelor IV + Ticagrelor 180mg at 0.5 hr

Experimental group

Description:

On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h after the initiation of cangrelor infusion.

Treatment:

Drug: cangrelor

Drug: Ticagrelor

Cangrelor IV + Ticagrelor 90mg (7 doses)

Experimental group

Description:

On Day 1: Following completion of cangrelor and ticagrelor dosing, patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 7 doses (12, 24, 36, 48, 60, 72, and 84 h). On Day 5: 12 h post last ticagrelor dose (90 mg), patients received another open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.

Treatment:

Drug: cangrelor

Drug: Ticagrelor

Cangrelor IV + Ticagrelor 180mg at 1.5 hr

Experimental group

Description:

On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 1.5 h after the initiation of cangrelor infusion.

Treatment:

Drug: cangrelor

Drug: Ticagrelor

Cangrelor IV + Ticagrelor 90mg (6 doses)

Experimental group

Description:

On Day 1: Following completion of cangrelor and ticagrelor dosing, patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 6 doses (12, 24, 36, 48, 60, and 72 h). On Day 5: 24 h post last ticagrelor dose (90 mg), patients received another open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.

Treatment:

Drug: cangrelor

Drug: Ticagrelor