Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,270
- 试验地点
- 1
- 主要终点
- Major Bleeding
研究概览
简要总结
A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural DOAC use.
详细描述
Rationale: Patients with atrial fibrillation (AF) often have coexisting coronary artery disease (CAD). An estimated 5 to 15% of all AF patients will require coronary stenting. Direct Oral Anticoagulants (DOAC) are more commonly used in preventing thromboembolic complications in patients with AF, thereby substituting the use of Vitamin-K Antagonists (VKA). Therefore, many patients undergoing invasive coronary angiography (ICA) and percutaneous coronary intervention (PCI) are taking direct oral anticoagulants (DOAC). In patients using VKA it is recommended to defer elective coronary angiography until international Normalized Ratio (INR) is <2.2 when radial artery access is used. However, no large clinical trials have proven the safety of continuing DOAC use when undergoing ICA or PCI. The current guidelines recommend interrupting DOAC treatment at least 24 before ICA or PCI; however, this recommendation is only based on limited data. Clinical decisions on DOAC use must therefore be based on clinical trials in which substantial numbers of patients with Acute Coronary Syndrome (ACS) were included.
Objective: To study the safety of DOAC continuation in patients undergoing ICA or PCI.
Study design: A prospective, multicenter, 1:1 randomized, investigator initiated study.
Study population: Patients aged >18 years using DOAC and undergoing elective ICA or PCI.
Intervention: The intervention group will continue using DOAC as usual. No adjustments of DOAC use will be made before and after ICA or PCI. The control group will receive standard care. DOAC use will be interrupted at least 24-48 hours in advance of ICA or PCI, based on renal clearance and DOAC specimen.
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
- 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 aged >18 years using DOAC and undergoing elective ICA or PCI.
- •Provided signed informed consent
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Any of the following:
- •Patients initially presenting with Acute Coronary Syndrome (STEMI, NSTEMI, UA)
- •Patients <18 years old
- •Calculated creatinine clearance <30 mL/min
- •Patients simultaneously participating in another clinical trial
- •History or condition associated with increased bleeding risk, as listed below:
- •Major surgical procedure within 30 days before the procedure
- •Known inaccessible radial artery during previous procedure
- •History of GI bleeding in the previous 6 months
- •History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
- •Chronic bleeding disorder
- •Known intracranial neoplasm, arteriovenous malformation, or aneurysm
- •Known anemia with last measured haemoglobin value <6 mmol/L [9.67 g/dL]
- •Current pregnancy or breast-feeding
- •Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis), or Alanine aminotransferase (ALT) >3 x the upper limit of normal.
- •Participation in another clinical trial
结局指标
主要结局
Major Bleeding
时间窗: 30 days
Non-CABG related in-hospital bleeding (BARC 2, 3 or 5)
次要结局
未报告次要终点
