A randomized, double-blind, triple-dummy, dose-ranging study, including an active control of unfractionated heparin and eptifibatide, to evaluate the clinical efficacy and safety of otamixaban, in patients with non-ST elevation acute coronary syndrome and planned early invasive strategy - SEPIA-ACS 1/TIMI 42

Conditions: Coronary desease in patients with non-ST elevation acute coronary syndrome and planned early invasive strategy
MedDRA version: 6.1Level: PTClassification code 10051592

Registration Number: EUCTR2006-000506-22-IT

Lead Sponsor: Sanofi Synthelabo Recherche

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2700

Inclusion Criteria

Male or non pregnant female 18 years old or older ; or country s legal age of majority Ischemic discomfort i.e. ischemic chest pain or equivalent at rest equal or greater 10 min within 24 hours of randomization Patient meets one of the two following criteria of non-ST elevation ACS -New ST-segment depression equal or greater 0.1 mV equal or greater 1 mm , or transient 30 minutes ST-segment elevation equal or greater 0.1 mV equal or greater 1 mm in at least 2 contiguous leads on the ECG, OR - Elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin T, troponin I, or CK-MB level above upper limit of normal Patient has no ST-elevation MI Planned coronary angiography, followed, when indicated, by PCI on Day 1 day of randomization to Day 3 Informed consent obtained in writing
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

General 1. Treatment with other investigational agents or devices within 30 days prior to randomization, or planned use of investigational agents or devices prior to the Day 30 visit 2. Inability to give informed consent, or high likelihood of being unavailable for the Day 180 follow 3. Breastfeeding 4. Pregnancy, as evidenced by a positive urine pregnancy test performed prior to randomization Cardiovascular 1. Anticipated inability to undergo a coronary angiography, and, if indicated PCI, by Day 3 2. Prior recent PCI performed within 30 days prior to randomization 3. Acute ST-segment elevation MI requiring immediate thrombolytic or primary PCI 4. Cardiogenic shock Related to prior or concomitant treatments 1. Patient received anticoagulant treatment for more than 24 hours prior to randomization. 2. Treatment with UFH or bivalirudin within 2 hours prior to randomization, unless aPTT 50 sec, or ACT 180 sec at the time of randomization 3. Treatment with LMWH within 8 hours prior to randomization 4. Administration of abciximab within 48 hours preceding randomization, or administration of tirofiban or eptifibatide within 4 hours preceding randomization 5. Any prior treatment with fondaparinux since onset of ACS 6. Requirement for oral anticoagulant prior to the Day 30 visit Related to eptifibatide 1. Known hypersensitivity to eptifibatide 2. Evidence of gastrointestinal bleeding, gross genitourinary bleeding, or other active abnormal bleeding within the previous 30 days 3. History of bleeding diathesis 4. Severe hypertension SBP 200 mmHg, or DBP 110 mmHg not adequately controlled on antihypertensive therapy 5. Recent 6 weeks trauma, or major surgery, including CABG 6. History of stroke within 30 days or any history of hemorrhagic stroke 7. Known history of intracranial disease 8. Current or planned administration of another GP IIb/IIIa inhibitor 9. Known thrombocytopenia 100,000/ l at randomization 10. Known International Normalized Ratio INR or equal to 2 11. Known creatinine clearance 30 ml/min or dependency on renal dialysis Related to clopidogrel 1. Known allergy to clopidogrel 2. Treatment with daily clopidogrel cannot be initiated at the time of randomization Related to aspirin 1. Known allergy to aspirin 2. Treatment with daily aspirin cannot be initiated at the time of randomization