Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery (FLIP-AF)

August 27, 2024 updated by: Population Health Research Institute

Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery (FLIP-AF): a Pilot Randomized Controlled Trial

Investigator-initiated pilot study of single dose oral flecainide versus no flecainide for the early conversion of perioperative atrial fibrillation to sinus rhythm after noncardiac surgery.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

FLIP-AF is a prospective, randomized, open-label trial of single dose flecainide versus no flecainide in patients with perioperative atrial fibrillation after noncardiac surgery. The primary objective is to determine whether it is feasible to conduct a large randomized controlled trial assessing the efficacy and safety of single dose flecainide in this population.

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years;
  • Noncardiac surgery in the last 30 days requiring an overnight hospital admission;
  • Presence of AF (i.e., atrial fibrillation and/or flutter) with a ventricular heart rate of ≥ 100 beats per minute at any time within 12 hours prior to randomization;
  • In AF at the time of randomization; AND,
  • Provided written informed consent.

Exclusion Criteria:

  • History of AF without normal sinus rhythm documented within 90 days prior to randomization;
  • Hemodynamic instability;

  • Have any one of the following contraindications to flecainide:

    1. known left ventricular ejection fraction ≤ 40%;
    2. myocardial infarction within the last 30 days;
    3. QRS interval >140ms;
    4. allergy to flecainide;
    5. severe uncorrected hypokalemia (<2.5 mEq/L) or hyperkalemia (>6.5 mEq/L) at the time of randomization;
    6. severe acute liver dysfunction or history of advanced cirrhosis;
    7. severe renal insufficiency (eGFR ≤ 30ml/min or dialysis); OR,
    8. second or third degree atrioventricular block within the last 30 days, in the absence of a pacemaker device;
  • Unable to take oral medication;
  • Previously enrolled in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flecainide
Participants randomized to the flecainide arm will be prescribed a single 300mg dose of oral flecainide, to be given as soon as possible after study randomization. Rate controlling drugs will be prescribed and titrated to achieve a heart rate of less than 100 beats per minute and symptom minimization.
Drug: Flecainide
Single 300mg dose of oral flecainide
No Intervention: No flecainide
Participants randomized to the no flecainide arm will not be prescribed flecainide. Rate controlling drugs will be prescribed and titrated to achieve a heart rate of less than 100 beats per minute and symptom minimization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: through study completion, an average of six months
Minimum recruitment rate of at least 1.5 patients per site per month
through study completion, an average of six months
Follow-up completion rate
Time Frame: through study completion, an average of six months
Completion rate of at least 90%
through study completion, an average of six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-FLIPAF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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