NCT00077792已完成3 期
A Randomized, Double-Blind, Double-Dummy , Parallel Group, Multinational, Clinical Study to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in Patients With Acute ST-Segment Elevation Myocardial Infarction Receiving Fibrinolytic Therapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 20,506
- 试验地点
- 48
- 主要终点
- Composite of all-cause mortality and non-fatal myocardial re-infarction
研究概览
简要总结
The primary objective of the study is to determine whether enoxaparin compared to unfractionated heparin will reduce the composite endpoint of all-cause mortality and non-fatal myocardial re-infarction within 30 days after randomization in patients with acute ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ST-segment elevation acute myocardial infarction meeting all of the following criteria:
- •Male or non-pregnant female greater than or equal to 18 years of age (depending on local regulations, minimal age can vary between 18 and 21 years)
- •Onset of prolonged (greater than or equal to 20 min) ischemic symptoms at rest less than or equal to 6 hours prior to randomization
- •ST-segment elevation of 0.1 mV in 2 or more limb leads, or 0.2 mV in two (2) or more contiguous precordial leads, or left bundle-branch block
- •Planned reperfusion therapy with streptokinase, tenecteplase, alteplase or reteplase
- •Written informed consent will be obtained
排除标准
- •Cardiovascular
- •Evidence of cardiogenic shock at randomization
- •Acute pericarditis
- •History or symptoms suggestive of aortic dissection
- •MI precipitated by obvious provoking factors such as arrhythmia, infection, severe anemia, hyperthyroidism, cocaine, or amphetamine
- •Hemorrhagic Risk
- •Any minor head trauma or any other trauma occurring after the index acute myocardial infarction
- •Active or recent (< 3 months) bleeding including gastrointestinal bleeding, known presence of occult blood in the stool, or gross hematuria.
- •Any history of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia
- •Any single reliable recording of systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg prior to randomization
- •Any history of stroke or transient ischemic attack; any history of hemorrhagic cerebrovascular disease
- •Any known structural damage or other pathologic process involving the central nervous system
- •Any head trauma within 6 months prior to randomization
- •Major surgery (including CABG), any ophthalmologic surgery, or non-cutaneous biopsy, or substantial trauma within 3 months prior to randomization
- •Traumatic or prolonged cardiopulmonary resuscitation (> 2 minutes) within 2 weeks prior to randomization
- •Puncture of a non-compressible vessel (artery or vein) within the 24 hours prior to randomization
- •Acute peptic ulcer disease within 3 months prior to randomization
- •Prior or Concomitant Pharmacologic Therapy
- •Administration of abciximab (ReoPro), within the previous 7 days or eptifibatide (Integrilin), or tirofiban (Aggrastat) within the previous 24 hours prior to randomization
- •Current therapy with oral anticoagulants, or an International Normalized Ratio of >1.5
- •Administration of a low molecular weight heparin within 8 hours prior to randomization.
- •Known hypersensitivity to low molecular weight heparins, unfractionated heparin or heparin-like products; allergy to pork or pork products
- •Known hypersensitivity and/or contra-indication(s) to fibrinolytic drugs (streptokinase, tenecteplase, alteplase and reteplase)
- •Known platelet count <100,000 cells/microL or history of heparin-induced thrombocytopenia
- •Known clinically significant anemia (Hemoglobin <10 g/dL which is < 6.2 mmol/L)
- •Known renal insufficiency with serum creatinine >220 mmol/L (2.5 mg/dL) for men and >175 mmol/L (2.0 mg/dL) for women when assessed prior to baseline examination.
- •Advanced neoplastic or other life-threatening disease with a life expectancy of <12 months
- •Pregnancy or parturition within the last 90 days or currently breast feeding
- •Women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having a negative pregnancy test.
- •Treatment with other investigational agents in the last 30 days before study entry or previous enrollment in ExTRACT-TIMI 25
- •History of drug or alcohol abuse
- •Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study
- •Any patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and who are unlikely to complete the study
结局指标
主要结局
Composite of all-cause mortality and non-fatal myocardial re-infarction
次要结局
- Composite of all-cause mortality, non-fatal myocardial re-infarction, and myocardial ischemia leading to urgent revascularization and non-fatal disabling stroke
研究者
研究点 (48)
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