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

Acute Coronary Syndrome Clinical Trial

— CHAMPION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156571
• Other study ID #: TMC-CAN-10-01
• Status: Completed
• Phase: Phase 3
• First received: June 29, 2010
• Last updated: January 2, 2014
• Start date: September 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: The Medicines Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11145
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atherosclerosis
• Percutaneous Coronary Intervention

Intervention

Drug:
• cangrelor P2Y12 (platelet) inhibitor

• Clopidogrel - 300 or 600 mg (study arm)
Over encapsulated tablets.
• Clopidogrel 600 mg post cangrelor
over-encapsulated clopidogrel (600 mg)

Locations

Country	Name	City	State
United States	Anderson Area Medical Center	Anderson	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
The Medicines Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)	Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population)	48 hours after randomization	No
Secondary	Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)	CEC-adjudicated results (mITT population)	48 hours after randomization	No
Secondary	Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild	GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial	48 hours after randomization	Yes