Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin In High Risk Patients Of Non-ST Elevation Acute Coronary Syndromes Intended For Early Invasive Strategy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30
研究概览
简要总结
To compare efficacy and safety of dalteparin compared to unfractionated heparin in patients of non ST elevation acute coronary syndromes who are planned to undergo coronary interventions (angioplasty or bypass surgery)
详细描述
The study was prematurely discontinued on November 30, 2008 due to delay in meeting pre-defined protocol recruitment milestones. There were no safety concerns regarding the study in the decision to terminate the trial.
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
- None
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 more than 18 years
- •Ischemic pain of more than 10 minutes within 24 hours before enrollment
- •At least two of the following three risk factors : Age more than 60 years ( or more than 50 in case of diabetics), Raised cardiac enzyme levels, abnormal ECG findings
排除标准
- •Contraindications to use of anticoagulants
- •Active bleeding or abnormal coagulation tests
- •Ischemic stroke within last 6 months or hemorrhagic stroke
- •Lumbar or spinal puncture within last 48 hours
- •S creatinine levels more than 2
研究组 & 干预措施
A
干预措施: Dalteparin ( Fragmin) (Drug)
B
干预措施: Unfractionated heparin (Drug)
结局指标
主要结局
Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30
时间窗: Baseline to Day 30
Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) on or before day 30 from baseline. Death: fatal event resulting from any cause. New MI: electrocardiographic (ECG) and or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test.
次要结局
- Number of Subjects With Stroke(End of hospitalization, Day 30)
- Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization(End of hospitalization, Day 30)
- Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days(End of hospitalization, Day 30)
- Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization(End of hospitalization, Day 30)
- Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria(End of hospitalization, Day 30)