Overview

A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
Summary
The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (PCI).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Medicines Company
Treatments:
Cangrelor
Clopidogrel
Ticlopidine
Criteria
Inclusion Criteria:

Patients may be included in the study if they meet all of the following criteria:

- Male or non-pregnant female at least 18 years of age

- Patients undergoing percutaneous coronary intervention (PCI):

1. Stable angina (SA) patients with diagnostic coronary angiography within 90 days
prior to randomization demonstrating atherosclerosis

2. Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with
diagnostic coronary angiography within 72 hours prior to randomization
demonstrating atherosclerosis

3. ST-segment elevation myocardial infarction (STEMI) patients (diagnostic
angiography not required)

- Provide written informed consent

Exclusion Criteria:

Patients will be excluded from the study if any of the following exclusion criteria apply
prior to randomization:

- Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization

- Eptifibatide and tirofiban usage within 12 hours preceding randomization (most recent
dose must have been administered ≥12 hours prior to randomization)

- Abciximab usage within 7 days preceding randomization

- Receipt of fibrinolytic therapy in the 12 hours preceding randomization

- Increased bleeding risk: ischemic stroke within the last year or any previous
hemorrhagic stroke; tumor, cerebral arteriovenous malformation, or intracranial
aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery);
currently receiving warfarin; active bleeding