Reassessment of Anti-Platelet Therapy Using InDividualized Strategies -Ticagrelor in Patients With Acute Coronary Syndromes Treated by Coronary Artery Bypass Graft Surgery - A Pharmacodynamic and Clinical Study to Decrease Bleeding Risks and Ischemic Complications - The RAPID-TITRATE CABG Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 4
- 主要终点
- Severe-massive bleeding
研究概览
简要总结
Ticagrelor, a more potent P2Y12 inhibitor, has been shown to reduce major adverse cardiac events (MACE) in acute coronary syndromes (ACS). It is increasingly used as a first line therapy in ACS. However, more potent P2Y12 inhibition has been associated with increased bleeding. This may be of particular concern for patients with ACS who require coronary artery bypass surgery (CABG). In particular, the timing for cessation of ticagrelor before proceeding to CABG is unclear. RAPID TITRATE CABG is a randomized vanguard study to evaluate the feasibility and preliminary safety of a strategy of early versus delayed CABG in ACS patients initially treated with ticagrelor and to identify potential mechanisms underlying benefits or complications of early bypass surgery.
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 (Investigator, Outcomes Assessor)
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
- •ACS patient referred for CABG and have received >= 1 dose of ticagrelor before decision for CABG made
排除标准
- •Patients are excluded if they:
- •refuse consent for enrollment
- •are deemed to require immediate CABG (Day 0 or day 1)
- •have a ST-elevation myocardial infarction (STEMI )initially treated with primary PCI
- •are undergoing concurrent valve surgery
- •are intolerant or allergic to aspirin
- •have been on an oral anticoagulant (including a vitamin K antagonist or a NOAC)
- •received adjuvant therapy with a glycoprotein IIbIIIa inhibitor
- •have a co-morbidity with life-expectancy of < 1 year
- •have active bleeding
结局指标
主要结局
Severe-massive bleeding
时间窗: 24 hours post CABG
Class 3 or 4 UDPB (universal definition for peri-operative bleeding)
12-hour chest tube drainage
时间窗: 12 hours post CABG
Chest tube drainage in the first 12 hours after bypass surgery
次要结局
- Transfusion (RBC)(48 hours post CABG)
- P2Y12 Reactivity Units (PRU) as a continuous variable(Baseline (at CABG), 24, 48, 72 hours post CABG)
- Other major bleeding criteria (BARC)(48 hours post CABG)
- Other major bleeding criteria (TIMI)(48 hours post CABG)
- Other major bleeding criteria (CABG related life threatening bleed)(48 hours post CABG)
- Transfusion (Platelet)(48 hours post CABG)
- Number of Patients with Major Adverse Cardiovascular Events (MACE) (To be collected but blinded to investigators,as this data will be carried from the vanguard study into a future definitive clinical trial).(6 months and 1 year)
- Peri-operative biomarker rise(48 hours post CABG)
- Number of Patients with Individual Components of Major Adverse Cardiovascular Events (MACE) (To be collected but blinded to investigators,as this data will be carried from the vanguard study into a future definitive clinical trial).(6 months and 1 year)
- ADP-induced Aggregation (AU) as a continuous variable(Baseline (at CABG), 24, 48, 72 hours post CABG)