Phase
Condition
Atherosclerosis
Myocardial Ischemia
Coronary Artery Disease
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Angiography demonstrating atherosclerosis amenable to treatment by percutaneous coronaryintervention (PCI) with or without stent implantation and diagnosis of Acute CoronarySyndrome (ACS) by elevated cardiac markers or ischemic chest discomfort w/electrocardiogramchanges + age > 65 or diabetes.
Exclusion
Exclusion Criteria:
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 previoushemorrhagic stroke, intra-cranial tumor, cerebral arteriovenous malformation, orintracranial aneurysm; recent (<1 month) trauma or major surgery [including coronaryartery 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 vonWillebrand's disease or hemophilia, acquired bleeding disorders, and unexplainedclinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL) at screening
Severe hypertension not adequately controlled by antihypertensive therapy at the timeof randomization
Receipt of fibrinolytic therapy in the 12 hours preceding randomization
Receipt of any thienopyridine (clopidogrel or ticlopidine) in the 7 days precedingrandomization
Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours [applicableto unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) patients]
Study Design
Connect with a study center
Innovis Health
Fargo, North Dakota 58104
United StatesSite Not Available
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