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

Phase 3

Completed

• Conditions: Percutaneous Coronary Intervention; Atherosclerosis; Acute Coronary Syndrome
• Interventions: Drug: Clopidogrel - 300 or 600 mg (study arm); Drug: cangrelor P2Y12 (platelet) inhibitor; Drug: Clopidogrel 600 mg post cangrelor

• Registration Number: NCT01156571
• Lead Sponsor: The Medicines Company

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-05
• Study Start: 2010-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-04-22
• Results First Submitted QC: 2013-04-22
• Results First Posted: 2013-06-18
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-02
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clopidogrel	Clopidogrel - 300 or 600 mg (study arm)	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.
cangrelor	cangrelor P2Y12 (platelet) inhibitor	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.
cangrelor	Clopidogrel 600 mg post cangrelor	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.

Primary Outcome Measures

Name	Time	Method
The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)	48 hours after randomization	Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat \[mITT\] population)

Secondary Outcome Measures

Name	Time	Method
Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)	48 hours after randomization	CEC-adjudicated results (mITT population)
Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild	48 hours after randomization	GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial

Trial Locations

Locations (1)

Anderson Area Medical Center; 🇺🇸 Anderson, South Carolina, United States