Comparison of Low-dose Heparin Versus Standard Dose Heparin During Coronary Interventions (DEDICA Trial)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- MACE + stent thrombosis + major bleeding (TIMI definition)
研究概览
简要总结
International guidelines support the use of a full-dose heparin (anticoagulants) during coronary intervention. However, a lower dose of heparin may be adequate, thanks to advances in angioplasty techniques and the widespread use of pretreatment with two antiplatelet agents.
Thus the investigators designed a study comparing safety and efficacy of standard dose heparin (100 UI/Kg) versus low-dose (50 UI/Kg) in patients undergoing coronary angioplasty who are on aspirin and clopidogrel at the time of the procedure.
详细描述
- Patients undergoing coronary angioplasty will be randomised to standard vs. low-dose heparin. the study will include "all-comers" (patients with either stable angina or acute coronary syndromes); only patients with ST-elevation myocardial infarction will be excluded.
- An ACT (activated clotting time) will be performed after the initial bolus of heparin: for the standard dose group the target ACT will be > 300 sec. (as recommended by guidelines) while for the low-dose the target ACT will be > 180 sec.
Aim of the study is to show equivalence in ischemic events between the two doses of heparin, in order to confirm the safety of lower dose of heparin in contemporary coronary interventions.
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
- Single (Participant)
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
- •Stable angina, unstable angina or Non-ST elevation myocardial infarction undergoing coronary angioplasty.
- •Mandatory pretreatment with aspirin and clopidogrel
排除标准
- •ST elevation myocardial infarction
- •Coronary interventions with rotational atherectomy
- •Coronary interventions on chronic total occlusions (CTO)
研究组 & 干预措施
Standard dose heparin
Bolus of 100 UI/Kg of heparin. Activated clotting time (ACT) > 300 sec. during the procedure
干预措施: Standard dose heparin (Drug)
Low-dose heparin
Bolus of 50 UI/Kg heparin with a target ACT during the procedure of >200 sec.
干预措施: Low-dose heparin (Drug)
结局指标
主要结局
MACE + stent thrombosis + major bleeding (TIMI definition)
时间窗: 30 days
MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition)
次要结局
- MACE(30 days)
- Major Bleeding(30 days)
- Stent thrombosis(30 days)
- CK-MB increase(30 days)
研究者
Vincenzo Pasceri
Attending Cardiologist
San Filippo Neri General Hospital