Atrial FibrillationPhase 4FLIP-AFNCT06142604
Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery
A Phase 4 study testing Flecainide in people with Atrial Fibrillation and Surgery, run by Population Health Research Institute.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Surgery
- What is being tested?
- Flecainide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- known left ventricular ejection fraction ≤ 40%;
- myocardial infarction within the last 30 days;
- QRS interval >140ms;
Show all 13Show fewer
- allergy to flecainide;
- severe uncorrected hypokalemia (<2.5 mEq/L) or hyperkalemia (>6.5 mEq/L) at the time of randomization;
- severe acute liver dysfunction or history of advanced cirrhosis;
- severe renal insufficiency (eGFR ≤ 30ml/min or dialysis); OR,
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation, Surgery
- Being tested
- Flecainide
- Keywords
- Flecainide
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlecainideDrug
Single 300mg dose of oral flecainide
| Study group | Role | What they receive |
|---|---|---|
| Flecainide | Experimental | 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. Receives: Drug: Flecainide |
| No flecainide | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Minimum recruitment rate of at least 1.5 patients per site per month
Measured: through study completion, an average of six months
Follow-up completion rate
Completion rate of at least 90%
Measured: through study completion, an average of six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142604
- Sponsor's protocol ID
- 2023-FLIPAF
- Acronym
- FLIP-AF
- Status last verified
- Aug 2024
- First submitted
- 10 Nov 2023
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery (FLIP-AF): a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06142604
- Acronym / sponsor ID
- FLIP-AF / 2023-FLIPAF
- Conditions
- Atrial Fibrillation, Surgery
- Keywords
- Flecainide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flecainide | Experimental | Drug: FlecainideParticipants 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. |
| No flecainide | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
- Unable to take oral medication;
- Previously enrolled in the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlecainideSingle 300mg dose of oral flecainide | Drug | Flecainide |
Primary outcome
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
Follow-up completion rate
Time frame: through study completion, an average of six months
Completion rate of at least 90%
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flecainide in people with Atrial Fibrillation and Surgery, run by Population Health Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: through study completion, an average of six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.