RecruitingPhase 3ACTRN12606000343505

CHAMPION PCI

A Clinical trial comparing Cangrelor to Clopidogrel in subjects who require percutaneous coronary intervention (PCI) to demonstrate that cangrelor is superior, or at least non-inferior, to that of clopidogrel as measured by a composite of all-cause mortality, myocardial infarction (MI) and ischaemia driven revascularisation (IDR).

Sponsor

The Medicines Company

Enrollment

9,000 participants

Start Date

May 23, 2006

Study Type

Interventional

Conditions

Myocardial Infarction Acute Coronary Syndromes Unstable Angina

Summary

Each year over 1 million patients globally undergo diagnostic angiography and are discovered to have atherosclerotic plaque amenable to percutaneous coronary intervention (PCI). This area has been extensively researched and benefit shown with the use of aspirin, and more recently 300mg loading dose and 75mg maintenance dose of clopidogrel. Despite the apparent benefit, many patients still do not receive a loading dose (either deliberately – as there is a reasonable probability of being triaged to CABG) or because there is insufficient time (stable patients undergoing diagnostic angiogram who proceed immediately to PCI). Cangrelor is a new drug being developed, which in early phase trials appears to be safe and well tolerated & will provide platelet inhibition throughout the infusion with full recovery of platelet function within 60min of stopping the infusion. This trial aims to demonstrate the efficacy of cangrelor compared to clopidogrel in patients requiring PCI. The primary endpoints to be measured will be all cause mortality, myocardial infarction (MI) and ischemia driven reinfarction (IDR) at 48hrs and 1 month, then mortality at 1year. This study will employ double blind and double dummy tachniques in addition to an active control. Subjects, Investigators, Study Monitor, Data Analyst and the sponsor The Medicines Company will be blinded.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

Diagnostic coronary angiography demonstrating atherosclerosis amenable to treatment by PCI with or without stent implantation and one of the following:
Non ST segment myocardial infarction with Troponin I or T greater than upper limit of normal within 24 hours of randomisation.
Unstable angina with ischaemic chest discomfort occurring at rest and lasting longer than 10 minutes within 24 hours of randomisation and with dynamic ECG changes with age greater than 65 years or diabetes.

Exclusion Criteria1

Glycoprotein IIb/IIIa (GPI) Inhibitor usuage within the previous 12 hours.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Subjects who fulfill the criteria and are to under go PCI will be randomised on a 1:1 randomisation to receive either 4 placebo capsules orally plus Cangrelor bolus (30ug/kg) & infusion (4 ug/kg/min)

Subjects who fulfill the criteria and are to under go PCI will be randomised on a 1:1 randomisation to receive either 4 placebo capsules orally plus Cangrelor bolus (30ug/kg) & infusion (4 ug/kg/min) for at least 2 hours or the duration of the procedure, whichever is longer. Post infusion be administered 4 Clopidogrel capsules (600mg) orally once. The other group would receive 4 Clopidogrel capsules (600mg) plus Placebo bolus (30 ug/kg) and infusion (4 ug/kg/min) for the duration of the procedure or 2 hours whichever is longer. At the end of the infusion they will receive 4 placebo capsules once. Clopidogrel maintenance is at the physicians discretion.