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: 8.1Level: LLTClassification code 10051592

Registration Number: EUCTR2006-000506-22-HU

Lead Sponsor: sanofi-aventis recherche&developpement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3240

Inclusion Criteria

• Male or non pregnant female = 18 years old (or = country’s legal age of majority)
• Ischemic discomfort (i.e. ischemic chest pain or equivalent) at rest = 10 min within 24 hours of randomization
• Patient meets one of the two following criteria of non-ST elevation ACS :
- New ST-segment depression = 0.1 mV (= 1 mm), or transient (< 30 minutes) ST-segment elevation = 0.1 mV (= 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
5. Known creatinine clearance < 30 ml/min or dependency on renal dialysis
6. Patients with body weight > 180 Kg
7. Any other condition, which, in the opinion of the Investigator may pose a significant hazard to the patients if he or she is enrolled in the trial
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(SBP <90 mmHg for at least 30 minutes or the need for supportive measures to maintain a SBP =90 mmHg AND either (a) end-organ hypoperfusion (cool extremities or urine output < 30ml/hour and a heart rate = 60 bpm) or (b) Cardiac Index = 2.2 l/min per square meter body surface area and a pulmonary capillary wedge pressure of at least 15 mmHg.).
Related to prior or concomitant treatments
1. Patient received anticoagulant treatment for more than 24 hours prior to randomization.
4. Inability to discontinue current anticoagulation in order to transition to study medication
according to the specified transition timing.
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/µl) at randomization
10. Known International Normalized Ratio (INR) = 2
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
Related to unfractionated heparin
1. History of heparin-induced thrombocytopenia syndrome