Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A Randomized, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients with Non-ST-segment Elevation Acute Coronary Syndrome(EARLY ACS) - EARLY ACS

Conditions: Patients who present with high-risk non-ST-segment elevation acute coronary syndrome who are planned to undergo an invasive strategy no sooner than the next calendar day following randomization.
MedDRA version: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndrome

Registration Number: EUCTR2004-000120-32-CZ

Lead Sponsor: Schering-Plough Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 9500

Inclusion Criteria

1. 18 years of age or older.
2. Willing and able to give informed consent. The patient must be able to comply with study procedures and follow-up through 1 year
3. Experiencing symptoms of cardiac ischemia at rest (angina or anginal equivalent) with episode(s) lasting at least 10 minutes within 24 hours of randomisation and have at least 2 of the following:
- Electrocardiogram (ECG) changes: New or presumable new ST-segment depression =0.1 mV (=1mm) or transient (<30minutes) ST-segment elevation =0.1mV (=1mm) in at least 2 contiguous leads
- Elevated troponin I or T greater than the established criteria at site or creatine kinase-MB fraction (CK-MB) greater than the site's upper limit of normal (ULN)
- 60 years of age or older.
Or have all 3 of the following:
- Prior History of cardiovascular disease (eg, prior MI, PCI, CABG, >50% coronary artery stenosis by angiography, ischemia present on exercise-stress imaging or pharmacologic-stress imaging study, peripheral vascular disease [PVD] with symptoms and objective evidence [eg, ankle brachial index {ABI}=0.9], nonhemorrhagic CVA)
- Elevated troponin I or T greater than the established criteria at each site
or CK-MB greater than the site’s ULN
- 50-59 years of age
4. Able to be randomised within 12 hours of presentation.
5. Plan to undergo an invasive strategy after administration of study drug for 12 to 96 hours.

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

Exclusion Criteria

1. Pregnancy-known or suspected-premenopausal females must have a confirmed negative urine or serum pregnancy test before study enrolment
2. Renal dialysis within 30 days prior to randomisation
3. Other serious illness (eg, active cancer within 5 years, sepsis) or any condition that the investigator feels would pose a significiant hazard to the patient if the investigational therapy was to be initiated.
4. History of a hemorrhagic stroke at any time or non-hemorrhagic stroke of any etiology within 7 days; central nervous system structural damage (eg, neoplasm, aneurysm, intracranial surgery);any recent severe head or facial trauma.
5. History of a bleeding diathesis, including documented gastrointestinal (GI) bleeding or any history of clinically significant GI bleeding, or evidence of active abnormal bleeding within 30 days prior to randomisation or an international normalised ratio (INR) >1.8 due to treatment with an oral anticoagulant or underlying coagulopathy.
6. Major surgery, biopsy of a parenchymal organ, or significant trauma within 14 days prior to randomisation
7. History of heparin or eptifibatide induced thrombocytopenia or a platelet count of <100,000 mm3. Platelet count should be confirmed by drawing a second blood sample.
8. Intent to use a direct thrombin inhibitor (other than bivalirudin [Angiomax®]), factor Xa inhibitor (other than fondaparinux [Arixtra®]), or any other anticoagulant other than UFH or low molecular weight heparins in accordance with local standard of care. (Exception: warfarin after completion of study drug infusion is permitted in patients with an indication for oral anticoagulation.)
9. Recent therapy with a GP IIB/IIIa inhibitor; abciximab within 24 hours prior to randomisation, or eptifibatide, tirofiban, or other agent within 4 hours prior to randomisation.
10 Known hypersensitivity to any component of the products evaluated in the study.