Phase
Condition
Chest Pain
Hypercholesterolemia
Blood Clots
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be aged >=18 years at the time of randomization.
Have symptoms which include at least 10 minutes of angina or anginal equivalent thatthe investigator believes has a high likelihood of being ischemic in origin within the 24 hours prior to randomization consistent with a diagnosis of Unstable Angina/Non-STElevation Myocardial Infarction (UA/NSTEMI) (patients with symptoms atypical forcardiac ischemia should not be enrolled).
Meet at least one of the following criteria for UA/NSTEMI:
All of the following four features: *Age >= to 65 years; *aspirin taken withinthe last 7 days; *two or more episodes of angina in the last 24 hours; *three ormore of the following risk factors: hypertension, high cholesterol, familyhistory, diabetes, current smoker OR
ECG changes: New or presumably new ST-segment depression >=0.1 MV (>=1mm), ortransient (<30 minutes) ST-segment elevation >=0.1MV (>=1mm) in at least 2contiguous leads, OR
Abnormal cardiac enzymes within the 24 hours before enrollment defined aselevated troponin I, T or creatine phosphokinase-MB isoenzyme (CPK-MB) levelgreater than the site's upper limit of normal (ULN) OR
History of coronary artery disease with documentation of one of the following: *prior angiography (coronary stenosis of >50%); *prior PCI or Coronary ArteryBypass Grafting (CABG); *prior definite, documented myocardial infarction.
Provide written informed consent before initiation of any study related procedures.
Exclusion
Exclusion Criteria:
Anticipated inability to perform angiography within 72 hours of randomization andanticipated inability to perform any intervention required (PCI or CABG) within theindex hospitalization.
ST segment elevation of >1 mm in 2 contiguous ECG leads lasting for >30 minutes, ornew left bundle branch block, or a clinical syndrome consistent with acute evolvingtransmural MI requiring immediate thrombolytic or interventional reperfusion therapy.
Cardiogenic shock (systolic blood pressure <80 mmHg for >30 minutes not responding tointravenous fluids, or requiring intravenous pressor agents or an intra-aortic balloonpump).
Bleeding diathesis or any history of hemorrhagic stroke or other intra-cerebral bleed,cerebral arteriovenous malformation, cerebral aneurysm or prior ischemic stroke withinthe last 2 years, or any prior stroke with residual neurologic deficit.Gastrointestinal or genitourinary bleeding within the last 2-weeks.
Platelet count <100,000 cells/mm3 at baseline, or history of heparin inducedthrombocytopenia
Patients on warfarin or phenprocoumon, unless they can be safely discontinued and thebaseline INR is < 1.5 times control.
Allergy to pork or pork products.
Patients who have been started on and received 2 or more doses of low molecular weightheparin for the current admission prior to randomization (patients who have receivedone dose of low molecular weight heparin may still be enrolled.
Patients who have been started on bivalirudin in the 6 hours prior to randomization
Thrombolytic therapy or abciximab use within the last 24 hours.
Treatment with a GPIIb/IIIa inhibitor at the time of randomization, which cannot bediscontinued.
Patients on Arixtra (fondaparinux).
Absolute contraindication or allergy to:
any one of enoxaparin, unfractionated heparin, bivalirudin or aspirin
both abciximab and eptifibatide
both eptifibatide and tirofiban
iodinated contrast which cannot be pre-medicated
Contraindications to angiography, including but not limited to severe peripheralvascular disease.
Angina from secondary causes.
Pregnancy or nursing mothers. Women of child bearing potential must have a negativeurine or serum pregnancy test prior to enrollment.
Calculated serum creatinine clearance < 30 mL/min (Determined by the Cockcroft Gaultformula: ((140-age in yrs) x weight in kg)/(814.464 x Creatinine in mmol/l) or /(72 x [Creatinine in mg/dL]). For women, multiply by 0.85.
Previous enrollment in this study.
Patients currently enrolled in another investigational drug study that has notcompleted the follow-up phase.
Study Design
Connect with a study center
Cardiovascular Research Foundation
New York, New York 10022
United StatesSite Not Available
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