Simplified Anti-Thrombotic Therapy for FFR (SMART-FFR)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FFR
Aspirin
Clopidogrel
Bivalirudin
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
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 .
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm 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
Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
Outcomes
Primary Outcome Measures
Thrombotic Complications
Secondary Outcome Measures
TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores
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.
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
Full Information
NCT ID
NCT02384070
First Posted
February 22, 2015
Last Updated
December 10, 2016
Sponsor
Odessa Heart Institute
1. Study Identification
Unique Protocol Identification Number
NCT02384070
Brief Title
Simplified Anti-Thrombotic Therapy for FFR
Acronym
SMART-FFR
Official Title
Evaluation of Simplified Anti-Thrombotic Therapy for Coronary Fractional Flow Reserve
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odessa Heart Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm 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
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
Intervention Type
Procedure
Intervention Name(s)
FFR
Other Intervention Name(s)
Fractional Flow Reserve
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Intervention Description
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
Primary Outcome Measure Information:
Title
Thrombotic Complications
Time Frame
Hospital Stay and after 30 days post PCI
Secondary Outcome Measure Information:
Title
TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores
Description
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.
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
Time Frame
Hospital Stay and after 30 days post PCI
Title
Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure
Time Frame
48 hours post procedure
10. Eligibility
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
12. IPD Sharing Statement
Learn more about this trial
Simplified Anti-Thrombotic Therapy for FFR
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