None listed
Conditions
Brief 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.
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) 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 proced
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.
Sponsors
The Medicines Company
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnostic coronary angiography demonstrating atherosclerosis amenable to treatment by PCI with or without stent implantation and one of the following: 1. Non ST segment myocardial infarction with Troponin I or T greater than upper limit of normal within 24 hours of randomisation. 2. 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 criteria
Glycoprotein IIb/IIIa (GPI) Inhibitor usuage within the previous 12 hours.
Outcome results
None listed