Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,788
- 试验地点
- 6
- 主要终点
- Net adverse clinical events (NACE)
研究概览
简要总结
The use of aspirin combined with a P2Y12 inhibitor (dual antiplatelet therapy, DAPT) represents the standard of care for patients undergoing percutaneous coronary intervention (PCI) with stent implantation. The TAILOR-DAPT trial aims to investigate the benefits of a score-based decision-making algorithm to guide DAPT duration compared to a standard-of-care DAPT duration without the use of risk scores in patients undergoing PCI.
详细描述
Background:
The use of aspirin combined with a P2Y12 inhibitor (dual antiplatelet therapy, DAPT) represents the standard of care for patients undergoing percutaneous coronary intervention (PCI) with stent implantation. European guidelines recommend to implement risk scores to guide the duration of DAPT after stent implantation (class IIb, level of evidence A). However, its adoption rate remains exceedingly low in daily clinical practice in part due to the lack of direct evidence obtained from a randomized controlled trial supporting this strategy.
Aim:
Using a pragmatic study-design, the investigators aim to determine the efficacy and safety of an algorithm-guided strategy for DAPT duration compared to a standard-of-care DAPT without the use of risk scores in patients undergoing PCI with stent implantation.
Methodology:
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
- Double (Participant, Outcomes Assessor)
盲法说明
Single-blind
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
- •PCI with drug eluting stent (DES) implantation
- •Age ≥18 years
- •Ability to sign informed consent before any study-specific procedure
排除标准
- •Planned staged PCI (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop an indication for percutaneous valve intervention can undergo treatment 30 days after full coronary revascularization)
- •Indication for oral anticoagulation
- •Peri-procedural complication which affects DAPT regimen based on the operator's opinion (e.g. untreated flow-limiting angiographic complication, intraprocedural stent thrombosis, persistent vessel occlusion/no-reflow at the end of the procedure, major side-branch occlusion, puncture-site related or other relevant bleeding)
- •Treatment for stent thrombosis at qualifying PCI or within 1 year prior to qualifying PCI
- •Active bleeding requiring medical attention at qualifying PCI
- •The presence of hemodynamic instability (persistent systolic blood pressure below 90mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and/or use of percutaneous left ventricular assist devices)
- •Life expectancy less than 1 year
- •Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile)
- •Planned surgery within the next 3 months
- •Contraindication or known allergy against aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel)
- •Participation in a drug trial
结局指标
主要结局
Net adverse clinical events (NACE)
时间窗: 1 year
All-cause death, spontaneous myocardial infarction, definite stent thrombosis, stroke or Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding
次要结局
- Major or clinically relevant non-major bleeding(1 year)
- Major adverse cardiovascular events (MACE)(1 year)
- Major bleeding(1 year)
- Any Bleeding Academic Research Consortium (BARC) bleeding(1 year)
- Target vessel revascularization(1 year)
- All-cause death(1 year)
- Target vessel myocardial infarction(1 year)
- Target lesion revascularization(1 year)
- Any revascularization(1 year)
- Cardiovascular death(1 year)
- Myocardial infarction(1 year)
- Spontaneous myocardial infarction(1 year)
- Target lesion failure(1 year)
- Non-target vessel revascularization(1 year)
- Transient ischemic attack(1 year)
- Definite stent thrombosis(1 year)
- Stroke(1 year)
- Adherence to DAPT(1 year)