A Clinical Trial Comparing Cangrelor To Clopidogrel In Subjects WhoRequire Percutaneous Coronary Intervention - Champion PCI
- Conditions
- Subjects with coronary atherosclerosis who require PCI (with orwithout stent).MedDRA version: 8.1Level: LLTClassification code 10011093Term: Coronary atherosclerosis
- Registration Number
- EUCTR2006-000192-14-DE
- Lead Sponsor
- The Medicines Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 9000
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 and one of the following:
2a. NSTEMI: Troponin I or T > upper limit of normal within 24-hours of randomization [or if troponin results are unavailable at that time, creatine kinase– myocardial band isoenzyme (CK-MB) > upper limit of normal]
2b. UA: Ischemic chest discomfort (angina or anginal equivalent) occurring at rest and lasting = 10 minutes within the 24 hours prior to randomization AND dynamic ECG changes† WITH either age= 65 years old and/or diabetes. 2c. STEMI: ECG changes including persistent [>20 minutes] ST-segment elevation in 2 or more contiguous leads
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
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
15. Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours (applicable to UA and NSTEMI patients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method