An International Randomized Study Evaluating the Efficacy and Safety of Fondaparinux Versus Control Therapy in a Broad Range of Patients With ST Segment Elevation Acute Myocardial Infarction.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12,092
- 主要终点
- Death or recurrent myocardial infarction
研究概览
简要总结
This is a randomized, double blindcontrolled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI (ST segment myocardial infarction) randomized within 24 hours of the onset of symptoms.
详细描述
This is a randomized, double blind, controlled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI randomized within 24 hours of the onset of symptoms. Patients with confirmed STEMI were assigned into one of the following strata, based on local preference:
Stratum 1: No indication for UFH; it is generally accepted that patients receiving streptokinase or those not receiving a thrombolytic agent were assigned to this stratum.
Stratum 2: Indication for UFH; it is generally accepted that patients receiving a fibrin-specific agent (such as alteplase, reteplase or tenecteplase) or those undergoing primary PCI were assigned to this stratum.
Patients who were ineligible for fibrinolysis (e.g. because of late presentation or absolute contra-indication for reperfusion therapy) may fall into either stratum 1 or stratum 2 at investigator's discretion. Following allocation to one of the strata, patients were randomized to fondaparinux or control treatment. Control treatment was dependent on whether the patient was assigned to stratum 1 or stratum 2:
Stratum 1: fondaparinux sc* versus fondaparinux-placebo sc for 8 days or until hospital discharge, whichever was earlier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who presented or were admitted to hospital with:
- •Signs and symptoms of AMI
- •Were able to randomize within 12 hours of symptom onset; and-
- •Had definite ECG changes indicating STEMI: persistent ST-elevation (≥0.2mV in two contiguous precordial leads, or ≥0.1mV in at least two limb leads), or new left bundle branch block, or ECG changes indicating true posterior MI.
- •Written informed consent
- •Able to be randomized within 24 hours of symptom onset
排除标准
- •Age <21 years.
- •Was currently receiving an oral anticoagulant agent with an INR >1.
- •Had any contraindication to anticoagulation therapy such as high risk of bleeding or active bleeding.
- •Had hemorrhagic stroke within the last 12 months.
- •Had an indication for anticoagulation other than ACS.
- •Pregnant women or women of child-bearing potential who were not using an effective method of contraception.
- •Had a co-morbid condition with a life-expectancy <6 months.
- •Previous enrollment in one of the fondaparinux ACS trials.
- •Participation in another pharmacotherapeutic study within the prior 30 days or was currently receiving an experimental pharmacological agent.
- •Had a known allergy to heparin or fondaparinux.
- •Had severe renal insufficiency (i.e. serum creatinine ≥3mg/dL or ≥265μmol/L).
- •Had >5000IU UFH administered prior to randomization.
- •Had LMWH administered prior to randomization.
- •Subject had pre-randomization revascularization (PCI) for the index event.
- •Subject had pre-randomization rescue PCI.
研究组 & 干预措施
Fondaparinux - UFH not indicated
Subjects with no indication for UFH therapy: 2.5mg od, sc, (1st dose IV) x 8 days or discharge
干预措施: fondaparinux - UFH not indicated (Drug)
Control - UFH not indicated
Subjects with no indication for UFH therapy: Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
干预措施: Control - UFH not indicated (Other)
Fondaparinux - UFH indicated
Subjects indicated for UFH: 2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus + 24-48 hr infusion
干预措施: Fondaparinux - UFH indicated (Drug)
Control - unfractionated heparin
Subjects indicated for UFH: UFH IV bolus +12 IU/kg/hr infusion x 24-48 hr + fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
干预措施: Control - UFH (Drug)
结局指标
主要结局
Death or recurrent myocardial infarction
时间窗: up to day 30
the first occurrence of any component of death (all-cause mortality) or recurrent myocardial infarction
Severe hemorrhage
时间窗: up to Day 9
Severe hemorrhage (modified TIMI criteria)
次要结局
- Death or recurrent myocardial infarction(up to Day 9, 90 and 180)
- Death, recurrent myocardial infarction or refractory ischemia(up to Day 9, 30, 90 and 180)