Simplified Anti-Thrombotic Therapy for FFR

NCT02384070 | Completed Results DMC

• 1 other identifier: 20095
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Thrombotic Complications

  Hospital Stay and after 30 days post PCI

Secondary Outcomes (2)

• TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores

  Hospital Stay and after 30 days post PCI

• Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure

  48 hours post procedure

Study Arms (3)

Group 1

EXPERIMENTAL

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

Procedure: FFR; Drug: Aspirin; Drug: Clopidogrel

Group 2

ACTIVE COMPARATOR

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

Procedure: FFR; Drug: Aspirin; Drug: Clopidogrel; Drug: Bivalirudin

Group 3

EXPERIMENTAL

Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin

Procedure: FFR; Drug: Aspirin; Drug: Bivalirudin

Interventions

FFR PROCEDURE

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.

Also known as: Fractional Flow Reserve

Group 1; Group 2; Group 3

Aspirin DRUG

All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure

Group 1; Group 2; Group 3

Clopidogrel DRUG

All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure

Group 1; Group 2

Bivalirudin DRUG

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

Group 2; Group 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Odessa Heart Institute: lead

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Fractional Flow Reserve, Myocardial; Aspirin; Clopidogrel; bivalirudin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Coronary Circulation; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Fernando Boccalandro MD FACC FSCAI
• Organization: Odessa Heart Institute / Permian Research Foundation

Fboccalandro@echd.org

432-3373117

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FACC FSACI

Study Record Dates

• First Submitted: February 22, 2015
• First Posted: March 10, 2015
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: February 3, 2017
• Results First Posted: February 3, 2017

Record last verified: 2016-12