A clinical trial comparing cangrelor to clopidogrel in subjects who require percutaneous coronary intervention. - CHAMPION PCI
- Conditions
- Subjects with coronary atherosclerosis who require percutaneous coronary intervention (PCI), with or without stent.MedDRA version: 9.1Level: LLTClassification code 10011093Term: Coronary atherosclerosis
- Registration Number
- EUCTR2006-000192-14-GB
- Lead Sponsor
- The Medicines Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 9000
To be included in this study, subjects must meet the following criteria:
1. Male or non-pregnant female at least 18 years of age
2. Diagnostic coronary angiography demonstrating atherosclerosis amenable to treatment by PCI with or without stent implantation
3. Provide written informed consent before initiation of any study-related procedure
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects will be excluded from the study if they present with any of the following:
1 .Planned staged PCI procedure where the second stage will occur ? 30 days after the first intervention
2 Admission planned for <12 hrs following PCI
3 Known or suspected pregnancy, or lactating females
4.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
5.Impaired hemostasis: known International Normalized Ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand’s disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL), or history of thrombocytopenia or neutropenia associated with clopidogrel
6.Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization (systolic blood pressure>180 mm Hg or diastolic blood pressure> 110 mm Hg)
7.Receipt of fibrinolytic therapy in the 12 hours preceding randomization
8.Receipt of a clopidogrel dose exceeding the maintenance dose (ie, >75 mg) at any time in the 5 days preceding randomization (subjects receiving chronic clopidogrel therapy at a dose of 75 mg are eligible)
9.Not a candidate for PCI
10.Inability to swallow study capsules
11.Allergy, hypersensitivity, or contraindication to clopidogrel, cangrelor, mannitol, sorbitol, or microcrystalline cellulose
12.Treatment with other investigational agents or devices within the 30 days preceding randomization, planned use of investigational drugs or devices, or previous enrollment in this trial
13.Known alcohol or illicit substance abuse
14.Inability to give informed consent or high likelihood of being unavailable for follow-up.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior to that of clopidogrel in subjects requiring PCI as measured by a composite of all-cause mortality, myocardial infarction (MI) and ischaemia-driven revascularisation(IDR).;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint is the composite incidence of all-cause mortality, mycardial infarction ischaemia-driven revascularisation assessed 48 hours after randomisation.
- Secondary Outcome Measures
Name Time Method