EUCTR2006-000506-22-PT进行中（未招募）不适用
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
Sanofi aventis recherche & développement0 个研究点目标入组 2,700 人开始时间: 2006年10月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •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.
- •2. Any prior treatment with fondaparinux since onset of ACS
- •3. Requirement for oral anticoagulant prior to the Day 30 visit
- •4. Inability to discontinue current anticoagulation in order to transition to study medication according to the specified transition timing.
- •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
研究者
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