Simplified Anti-Thrombotic Therapy for FFR

Coronary Artery Disease Clinical Trial

— SMART-FFR  

Official title:

Evaluation of Simplified Anti-Thrombotic Therapy for Coronary Fractional Flow Reserve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384070
• Other study ID #: 20095
• Status: Completed
• Phase: N/A
• First received: February 22, 2015
• Last updated: March 4, 2015
• Start date: January 2009
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Odessa Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 .

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• FFR
Fractional flow reserve tracings were calculated using a Volcano pressure wire intra-coronary system after ensuring proper calibration of the aortic pressure transducer and the guidewire, using 6 Fr-guide catheters. Before crossing the stenosis, baseline pressure was measured by the guide catheter and the pressure guidewire were equalized according to the manufacturer's specifications. After advancing the pressure sensor across the stenosis, coronary hyperemia was induced using intravenous adenosine (140µg/kg/min until a steady state was reached for at least 3 minutes). Fractional flow reserve was considered positive if it was less than 0.80.

Drug:
• Aspirin
All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
• Clopidogrel
All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure
• Bivalirudin
Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Odessa Heart Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombotic complications		whether intra-procedural or during the hospital stay participants will be followed for the duration of hospital stay, an expected average of 2 days.	No
Secondary	TIMI (Thrombolysis in myocardial infarction) major and minor bleeding scores		whether intra-procedural or during the hospital stay participants will be followed for the duration of hospital stay, an expected average of 2 days.	No
Secondary	Sub-clinical ischemic events measured by troponin levels post-procedure		whether intra-procedural or during the hospital stay participants will be followed for the duration of hospital stay, an expected average of 2 days.	No