Status:
COMPLETED
Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes (ACS)
Lead Sponsor:
The Medicines Company
Conditions:
Unstable Angina
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to show that, when compared with heparin (enoxaparin or unfractionated heparin) and routine GPIIb/IIIa inhibition (either started upfront or at the time of percutaneous co...
Eligibility Criteria
Inclusion
- Be aged \>=18 years at the time of randomization.
- Have symptoms which include at least 10 minutes of angina or anginal equivalent that the 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-ST Elevation Myocardial Infarction (UA/NSTEMI) (patients with symptoms atypical for cardiac 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 within the last 7 days; \*two or more episodes of angina in the last 24 hours; \*three or more of the following risk factors: hypertension, high cholesterol, family history, diabetes, current smoker OR
- ECG changes: New or presumably new ST-segment depression \>=0.1 MV (\>=1mm), or transient (\<30 minutes) ST-segment elevation \>=0.1MV (\>=1mm) in at least 2 contiguous leads, OR
- Abnormal cardiac enzymes within the 24 hours before enrollment defined as elevated troponin I, T or creatine phosphokinase-MB isoenzyme (CPK-MB) level greater 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 Artery Bypass Grafting (CABG); \*prior definite, documented myocardial infarction.
- Provide written informed consent before initiation of any study related procedures.
Exclusion
- Anticipated inability to perform angiography within 72 hours of randomization and anticipated inability to perform any intervention required (PCI or CABG) within the index hospitalization.
- ST segment elevation of \>1 mm in 2 contiguous ECG leads lasting for \>30 minutes, or new left bundle branch block, or a clinical syndrome consistent with acute evolving transmural MI requiring immediate thrombolytic or interventional reperfusion therapy.
- Cardiogenic shock (systolic blood pressure \<80 mmHg for \>30 minutes not responding to intravenous fluids, or requiring intravenous pressor agents or an intra-aortic balloon pump).
- Bleeding diathesis or any history of hemorrhagic stroke or other intra-cerebral bleed, cerebral arteriovenous malformation, cerebral aneurysm or prior ischemic stroke within the 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 induced thrombocytopenia
- Patients on warfarin or phenprocoumon, unless they can be safely discontinued and the baseline 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 weight heparin for the current admission prior to randomization (patients who have received one 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 be discontinued.
- 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 peripheral vascular disease.
- Angina from secondary causes.
- Pregnancy or nursing mothers. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.
- Calculated serum creatinine clearance \< 30 mL/min (Determined by the Cockcroft Gault formula: ((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 not completed the follow-up phase.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
13800 Patients enrolled
Trial Details
Trial ID
NCT00093158
Start Date
August 1 2003
End Date
January 1 2007
Last Update
August 21 2007
Active Locations (1)
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1
Cardiovascular Research Foundation
New York, New York, United States, 10022