Simplified Anti-Thrombotic Therapy for FFR

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: FFR; Drug: Aspirin; Drug: Clopidogrel; Drug: Bivalirudin

• Registration Number: NCT02384070
• Lead Sponsor: Odessa Heart Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Study First Submitted: 2015-02-22
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Results First Submitted: 2016-04-10
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-10
• Last Update Submitted: 2016-12-10
• Results First Posted: 2017-02-03
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 300

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.

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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 .

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	FFR	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
Group 1	Aspirin	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
Group 2	FFR	Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
Group 2	Bivalirudin	Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
Group 3	FFR	Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
Group 1	Clopidogrel	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
Group 2	Aspirin	Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
Group 2	Clopidogrel	Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
Group 3	Aspirin	Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
Group 3	Bivalirudin	Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin

Primary Outcome Measures

Name	Time	Method
Thrombotic Complications	Hospital Stay and after 30 days post PCI

Secondary Outcome Measures

Name	Time	Method
TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores	Hospital Stay and after 30 days post PCI	1. Major: Intracranial bleeding, Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in haematocrit or Fatal bleeding.; 2. Minor: Clinically overt (including imaging), resulting in hemoglobin drop of 3 to \<5 g/dL or ≥10% decrease in haematocrit. No observed blood loss: ≥4 g/dL decrease in the haemoglobin concentration or ≥12% decrease in haematocrit Any overt sign of hemorrhage that meets one of the following criteria and does not meet criteria for a major or minor bleeding event, as defined above Requiring intervention
Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure	48 hours post procedure