Current partner codePEPTIDESDE
NCT02384070·Not applicable·INTERVENTIONAL

Simplified Anti-Thrombotic Therapy for FFR

Status

Completed

Phase

Not applicable

Enrollment

300

Locations

0

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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

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

Timeline

From registration to results.

  1. First posted

    Mar 10, 2015

  2. Study start

    Jan 2009

  3. Primary completion

    Dec 2013

  4. Study completion

    Dec 2014

  5. Results posted

    Feb 3, 2017

  6. Registry updated

    Feb 3, 2017

Outcomes

What the study measures.

Primary outcomes

Thrombotic Complications

Time frame · Hospital Stay and after 30 days post PCI

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.