Uninterrupted Direct-acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Rate of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5
研究概览
简要总结
Up to 20-30% of patients who are candidates for direct oral anticoagulation (DOAC) present with concomitant ischemic heart disease and often require coronary angiography with or without percutaneous coronary intervention (PCI). The decision whether to continue the DOAC throughout periprocedural period or interrupt DOAC before planned procedure represents a substantial challenge in daily clinical practice.
The objective of this study is to evaluate the safety of uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures.
详细描述
The study design is an investigator-initiated, single-arm, open-label, pilot study in patients treated with DOAC undergoing trans-radial percutaneous coronary procedures.
Because of the exploratory nature of this study, no formal sample size calculations are required. On the basis of previous pilot studies with similar designs, a sample of 200 patients is planned; with a safety stopping rule based on the occurrence of BARC type 3 or 5 bleeding. In the present trial, if during the enrollment period more than 3 cases of BARC 3 or 5 bleeding occur up to 30-day follow-up, patient recruitment will be terminated. This number is based on the reported 1.6% BARC type 3 or 5 bleeding in patients undergoing transradial percutaneous coronary procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under anticoagulation with DOAC and any indication for diagnostic or therapeutic trans-radial percutaneous coronary procedures. At least 25% of the population undergoing PCI will be included.
排除标准
- •Aged < 18 years
- •Cardiogenic shock
- •Major active bleeding at the time of the procedure
- •Use of mechanical circulatory support
- •Chronic total occlusions
- •Pre-planned vascular access different from radial artery access (i.e. femoral, brachial, ulnar)
- •Inability to provide informed consent
- •Unable to understand and follow study-related instructions or unable to comply with study protocol
- •Currently participating in another trial
- •Pregnant women
研究组 & 干预措施
Uninterruped direct-acting oral anticoagulation
Uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures
干预措施: Direct-acting oral anticoagulation (Drug)
结局指标
主要结局
Rate of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5
时间窗: 30-day follow-up
次要结局
- Rate of BARC type 3, or 5(30-day follow-up)
- Rate of definite/probable stent thrombosis(30-day follow-up)
- Rate of definite stent thrombosis(30-day follow-up)
- Rate of all-cause death(30-day follow-up)
- Rate of cardiac death(30-day follow-up)
- Rate of stroke(30-day follow-up)
- Rate of myocardial infarction(30-day follow-up)
- Rate of target-lesion revascularization(30-day follow-up)
- Rate of target-vessel revascularization(30-day follow-up)
研究者
Jorge Sanz Sanchez
Principal Investigator
Hospital Universitario La Fe