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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

The Medicines Company

ClinicalTrials.gov Identifier:

NCT01156571

First received: June 29, 2010

Last updated: January 9, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	June 29, 2010
Last Updated Date	January 9, 2013
Start Date ^ICMJE	September 2010
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 1, 2010)	A composite incidence of all-cause mortality, myocardial infarction, ischemia-driven revascularization and stent thrombosis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01156571 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 1, 2010)	Incidence of stent thrombosis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)
Official Title ^ICMJE	A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX)
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Atherosclerosis Percutaneous Coronary Intervention Acute Coronary Syndrome
Intervention ^ICMJE	Drug: cangrelor P2Y12 (platelet) inhibitor dosage as per standard of care Drug: Clopidogrel tablet
Study Arm (s)	Experimental: cangrelor Intervention: Drug: cangrelor P2Y12 (platelet) inhibitor Active Comparator: clopidogrel Intervention: Drug: Clopidogrel
Publications *	Bhatt DL, Stone GW, Mahaffey KW, Gibson CM, Steg PG, Hamm CW, Price MJ, Leonardi S, Gallup D, Bramucci E, Radke PW, Widimský P, Tousek F, Tauth J, Spriggs D, McLaurin BT, Angiolillo DJ, Généreux P, Liu T, Prats J, Todd M, Skerjanec S, White HD, Harrington RA; CHAMPION PHOENIX Investigators. Effect of platelet inhibition with cangrelor during PCI on ischemic events. N Engl J Med. 2013 Apr 4;368(14):1303-13. doi: 10.1056/NEJMoa1300815. Epub 2013 Mar 10. PubMed PMID: 23473369. Leonardi S, Mahaffey KW, White HD, Gibson CM, Stone GW, Steg GW, Hamm CW, Price MJ, Todd M, Dietrich M, Gallup D, Liu T, Skerjanec S, Harrington RA, Bhatt DL. Rationale and design of the Cangrelor versus standard therapy to acHieve optimal Management of Platelet InhibitiON PHOENIX trial. Am Heart J. 2012 May;163(5):768-776.e2.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	11145
Completion Date	December 2012
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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): Stable angina (SA) patients with diagnostic coronary angiography within 90 days prior to randomization demonstrating atherosclerosis Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01156571
Other Study ID Numbers ^ICMJE	TMC-CAN-10-01
Has Data Monitoring Committee	Not Provided
Responsible Party	The Medicines Company
Study Sponsor ^ICMJE	The Medicines Company
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	The Medicines Company
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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