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

The Medicines Company

Status and phase: Completed; Phase 3

Conditions: Percutaneous Coronary Intervention; Acute Coronary Syndrome; Atherosclerosis

Treatments: Drug: Clopidogrel 600 mg post cangrelor; Drug: cangrelor P2Y12 (platelet) inhibitor; Drug: Clopidogrel - 300 or 600 mg (study arm)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01156571

TMC-CAN-10-01

Details and patient eligibility

About

The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (PCI).

Enrollment: 11,145 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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11,145 participants in 2 patient groups

cangrelor

Experimental group

Description:

Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. Following the discontinuation of the cangrelor infusion, 600mg of clopidogrel was administered.

Treatment:

Drug: cangrelor P2Y12 (platelet) inhibitor

Drug: Clopidogrel 600 mg post cangrelor

clopidogrel

Active Comparator group

Description:

Clopidogrel 300 mg or 600 mg administered pre or post PCI. Selection of dose and timing of dose were per investigator discretion. During the PCI a placebo infusion was given to maintain the blinding of the trial. In addition, placebo capsules were administered at the end of the infusion mimic the 600mg post infusion dose provided in the cangrelor arm.

Treatment:

Drug: Clopidogrel - 300 or 600 mg (study arm)