Maintenance of Platelet Inhibition With Cangrelor (Bridge)

The Medicines Company

Status and phase: Completed; Phase 2

Conditions: Acute Coronary Syndrome (ACS)

Treatments: Other: Placebo; Drug: cangrelor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00767507

TMC-CAN-08-02

Details and patient eligibility

About

The purpose of this study is to demonstrate that patients receiving cangrelor infusion before coronary artery bypass grafting have an acceptable safety profile and can undergo surgery without excessive bleeding peri-operatively.

Enrollment: 221 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• 18 Years of Age
• Non emergent coronary bypass graft surgery
• Received a thienopyridine within 48 hours prior to enrollment

Exclusion criteria

• Confirmed or suspected pregnancy
• Cerebrovascular accident within one yar
• Intracranial neoplasm
• History of bleeding diathesis
• Thrombocytopenia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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221 participants in 2 patient groups, including a placebo group

Cangrelor

Experimental group

Description:

Cangrelor was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days.

Treatment:

Drug: cangrelor

Placebo

Placebo Comparator group

Description:

A placebo infusion was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days, to maintain the blind.

Treatment:

Other: Placebo