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NCT Number: NCT06657404

The Modified "Pills-in-the-Pocket" Strategy

This is a multicentre, prospective, randomised controlled study of 328 patients with non-paroxysmal AF (within 5 years of first diagnosis of AF) with recurrent atrial arrhythmias after first catheter ablation, randomly divided in a 1:1 ratio into a study group treated with triple AADs (amiodarone + bisoprolol + digoxin) and a control group treated with conventional AADs (amiodarone + bisoprolol + digoxin). The study group was treated with triple AADs (amiodarone + bisoprolol) and the control group was treated with conventional AADs (amiodarone + bisoprolol) with the aim of comparing the efficacy and safety of the two groups in terms of reversion of SR, which may provide an effective option of pocket drug reversion for patients with recurrence of SR after AF catheter ablation.

Translated with DeepL.com (free version)

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(1) Age ≥18 years; (2) Non-valvular, non-paroxysmal AF (within 5 years of the first diagnosis of AF) with recurrent atrial arrhythmia lasting for more than 24 hours after the first catheter ablation and not self-terminating; (3) Patients who are not taking AADs such as amiodarone, dronedarone, propafenone, etc. after the procedure, and who agree to receive AADs without contraindications to AADs; or patients who are taking AADs such as amiodarone, dronedarone, propafenone, etc. after the procedure, but have been off of them for more than 1 month.

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Exclusion criteria

(1) Previous cardiac surgery, such as cardiac bypass grafting, mechanical valve or prosthetic valve replacement; (2) Combined cardiomyopathy (e.g. hypertrophic cardiomyopathy, dilated cardiomyopathy, ischaemic cardiomyopathy, etc.); (3) Cardiac ultrasound suggests that the diameter of the left atrium is ≥50mm or there are valvular changes in rheumatic heart disease; (4) Previous history of abnormal thyroid function; (5) Severe hepatic or renal insufficiency (eGFR <15, Child Class 3), or history of renal dialysis; (6) Heart rate <60 beats/minute, any degree of atrioventricular block, two-branch or three-branch block at the time of resumption of SR after catheter ablation; (7) Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III-IV after catheter ablation; (8) Participation in a clinical trial of another drug or device during the same period; (9) Abnormalities or diseases that, in the opinion of the investigator, should be excluded from enrolment in this study.

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Treatment and study plan

use Amiodarone, Bisoprolol and Digoxin

Drug

Amiodarone 200mg tid orally for 1 week, then reduced to 200mg bid orally for another week.

The dose of amiodarone will be reduced to 200mg bid orally for 1 week, and then 200mg qd maintenance treatment will be started in the 3rd week of dosing.

Bisoprolol 2.5-5mg qd oral treatment, the specific dose is decided by the investigator.

Digoxin 0.125mg qd orally.

Primary outcomes

  1. converted to sinus rhythm

    Time frame: 1 month

    Patients with recurrent atrial arrhythmia after catheter ablation for non-paroxysmal AF (within 5 years of history of first AF diagnosis) within 1 month converted to sinus rhythm using AADs

Secondary outcomes

  1. Composite endpoint event of bradycardia, cardiovascular hospitalisation or death

    Time frame: 1 month

    Bradycardia: heart rate <60 beats/minute, any degree of atrioventricular block and/or more than two-branch block, and prolonged QTc interval (>500ms).

    Cardiovascular hospitalisation: defined as hospitalisation or emergency admission due to recurrence of atrial arrhythmia, heart failure or serious adverse effects of AADs during the follow-up period after enrolment; all treatments during the period of admission or admission to an emergency clinic count as one hospitalisation.

    Heart failure: defined as an episode of left or right ventricular failure requiring hospitalisation.

    Serious adverse events of AADs: Torsade de pointes (Tdp), ventricular tachycardia or atrial fibrillation, atrial flutter (atrioventricular (AV) conduction ratio of 1:1), third-degree AV block, sick sinus node syndrome, digitalis toxicity, and drug-induced heart failure were classified as serious adverse events of AADs. All possible endpoints were adjudicated by experts not involved in the diagnosis and treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Yumei Xue, phD

CONTACT

[email protected]

13570082363

Sponsors and collaborators

Lead sponsor

Yumei Xue

Other

Collaborators

  • Beijing Anzhen Hospital
  • First Affiliated Hospital, Sun Yat-Sen University
  • Jiangmen Central Hospital
  • Nanfang Hospital, Southern Medical University
  • Sir Run Run Shaw Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Xiamen Cardiovascular Hospital
  • Yan'an Affiliated Hospital of Kunming Medical University
  • Zhongshan People's Hospital, Guangdong, China

Registry information

Official study title

The Modified "Pills-in-the-Pocket" Strategy -The Combined Effect of Amiodarone, Bisoprolol and Digoxin in the Treatment of Recurrent Atrial Arrhythmia for Non-Paroxysmal Atrial Fibrillation After Catheter Ablation: A Multicenter, Prospective, Randomized, Open-Label, Blinded Endpoint Clinical Trial

Acronym: ABD-AF

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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