Status:
TERMINATED
Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition.
Lead Sponsor:
The Medicines Company
Conditions:
Atherosclerosis
Acute Coronary Syndrome (ACS)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to demonstrate that the efficacy of cangrelor (combined with usual care) is superior to that of usual care, in subjects requiring percutaneous coronary intervent...
Eligibility Criteria
Inclusion
- Angiography demonstrating atherosclerosis amenable to treatment by percutaneous coronary intervention (PCI) with or without stent implantation and diagnosis of Acute Coronary Syndrome (ACS) by elevated cardiac markers or ischemic chest discomfort w/electrocardiogram changes + age \> 65 or diabetes.
Exclusion
- Not a candidate for PCI
- ST-segment elevation myocardial infarction (STEMI) within 48 hours of randomization
- Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, intra-cranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (\<1 month) trauma or major surgery \[including coronary artery bypass graft (CABG) surgery\]; currently receiving warfarin, active bleeding
- Impaired hemostasis: known International Normalized Ratio (INR) \>1.5 at screening; 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) at screening
- Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization
- Receipt of fibrinolytic therapy in the 12 hours preceding randomization
- Receipt of any thienopyridine (clopidogrel or ticlopidine) in the 7 days preceding randomization
- Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours \[applicable to unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) patients\]
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
5364 Patients enrolled
Trial Details
Trial ID
NCT00385138
Start Date
September 1 2006
End Date
June 1 2010
Last Update
May 5 2014
Active Locations (1)
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1
Innovis Health
Fargo, North Dakota, United States, 58104