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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02384070
Recruitment Status : Completed
First Posted : March 10, 2015
Results First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Fernando Boccalandro MD, Odessa Heart Institute

Tracking Information
First Submitted Date  ICMJE February 22, 2015
First Posted Date  ICMJE March 10, 2015
Results First Submitted Date  ICMJE April 10, 2016
Results First Posted Date  ICMJE February 3, 2017
Last Update Posted Date February 3, 2017
Study Start Date  ICMJE January 2009
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2016)
Thrombotic Complications [ Time Frame: Hospital Stay and after 30 days post PCI ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
Thrombotic Complications [ Time Frame: whether intra-procedural or during the hospital stay participants will be followed for the duration of hospital stay, an expected average of 2 days. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2016)
  • TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores [ Time Frame: 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 [ Time Frame: 48 hours post procedure ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
  • TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores [ Time Frame: whether intra-procedural or during the hospital stay participants will be followed for the duration of hospital stay, an expected average of 2 days. ]
  • Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure [ Time Frame: whether intra-procedural or during the hospital stay participants will be followed for the duration of hospital stay, an expected average of 2 days. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simplified Anti-Thrombotic Therapy for FFR
Official Title  ICMJE Evaluation of Simplified Anti-Thrombotic Therapy for Coronary Fractional Flow Reserve
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • 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.
    Other Name: Fractional Flow Reserve
  • Drug: Aspirin
    All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
  • Drug: Clopidogrel
    All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure
  • Drug: 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
Study Arms  ICMJE
  • Experimental: 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
    Interventions:
    • Procedure: FFR
    • Drug: Aspirin
    • Drug: Clopidogrel
  • Active Comparator: Group 2
    Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
    Interventions:
    • Procedure: FFR
    • Drug: Aspirin
    • Drug: Clopidogrel
    • Drug: Bivalirudin
  • Experimental: Group 3
    Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
    Interventions:
    • Procedure: FFR
    • Drug: Aspirin
    • Drug: Bivalirudin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2015)
300
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 .
Sex/Gender  ICMJE Not Provided
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02384070
Other Study ID Numbers  ICMJE 20095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fernando Boccalandro MD, Odessa Heart Institute
Study Sponsor  ICMJE Odessa Heart Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Odessa Heart Institute
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP