Evaluation of Simplified Anti-Thrombotic Therapy for Coronary Fractional Flow Reserve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Thrombotic Complications
研究概览
简要总结
Despite the routine use of procedural anti-coagulation and anti-platelet therapy for FFR calculation, no study has evaluated the optimal anti-thrombotic regimen in patients undergoing FFR. Therefore, the aim of the Evaluation of Simplified Anti-Thrombotic Therapy for Coronary Fractional Flow Reserve (SMART-FFR) study was to evaluate the safety of using a simplified anti-thrombotic regimen with only upstream dual anti-platelet therapy (DAT) with aspirin and clopidogrel, compared with anticoagulation plus single- or- DAT therapy in patients with intermediate coronary artery stenosis undergoing FFR calculation during elective coronary angiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 接受健康志愿者
- 否
入选标准
- •All patient regardless of sex, or age were eligible for the study if they were scheduled for an elective coronary angiography using a femoral approach, and were agreeable to participate in the study after signing informed consent, and had a coronary stenosis in any major native epicardial coronary artery between 50-70% determined by quantitative angiography that was an adequate target for FFR at the discretion of the operator.
排除标准
- •Exclusion criteria included patients requiring mandatory DAT, patient undergoing radial access due to concomitant anticoagulation, patients with contra-indications or intolerant to DAT, patients with severe left ventricular hypertrophy defined as a wall thickness greater than 14 mm by echocardiography in the septal or lateral wall, patients with hypertrophic cardiomyopathy, left ventricular function less than 30%, severe aortic valvular stenosis defined as an aortic valve area of less than 1 cm2, presenting with an acute coronary syndrome in the past two weeks, hemodynamic instability, cardiogenic shock, reported allergy to clopidogrel, aspirin or bivalirudin, planned to be anticoagulated during or previous to the time of the coronary angiography, using Prasugrel or Ticagrelor, patients with coronary arteries unsuitable for FFR calculation due to severe tortuousity and/or calcification, lesions supplied by a bypass conduit, any mental condition rendering the subject incapable to understand the nature, scope, and possible consequences of the study such that the patient is unable to give appropriate informed consent or refusal or inability to sign an informed consent .
研究组 & 干预措施
Group 1
Received upstream aspirin plus clopidogrel with no intra-procedural anticoagulation for the FFR calculation with a saline bolus and drip used for placebo anticoagulation during the procedure to blind the operator
干预措施: FFR (Procedure)
Group 1
Received upstream aspirin plus clopidogrel with no intra-procedural anticoagulation for the FFR calculation with a saline bolus and drip used for placebo anticoagulation during the procedure to blind the operator
干预措施: Aspirin (Drug)
Group 1
Received upstream aspirin plus clopidogrel with no intra-procedural anticoagulation for the FFR calculation with a saline bolus and drip used for placebo anticoagulation during the procedure to blind the operator
干预措施: Clopidogrel (Drug)
Group 2
Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
干预措施: FFR (Procedure)
Group 2
Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
干预措施: Aspirin (Drug)
Group 2
Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
干预措施: Clopidogrel (Drug)
Group 2
Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
干预措施: Bivalirudin (Drug)
Group 3
Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
干预措施: FFR (Procedure)
Group 3
Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
干预措施: Aspirin (Drug)
Group 3
Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
干预措施: Bivalirudin (Drug)
结局指标
主要结局
Thrombotic Complications
时间窗: Hospital Stay and after 30 days post PCI
次要结局
- TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores(Hospital Stay and after 30 days post PCI)
- Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure(48 hours post procedure)
研究者
Fernando Boccalandro MD
MD FACC FSACI
Odessa Heart Institute