Simplified Anti-Thrombotic Therapy for FFR (SMART-FFR)

Odessa Heart Institute

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Drug: Bivalirudin

Drug: Clopidogrel

Procedure: FFR

Drug: Aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT02384070

20095

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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 .

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

300 participants in 3 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Procedure: FFR

Drug: Clopidogrel

Drug: Aspirin

Group 2

Active Comparator group

Description:

Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation

Treatment:

Drug: Bivalirudin

Procedure: FFR

Drug: Clopidogrel