The Modified "Pills-in-the-Pocket" Strategy
ABD-AF
1 other identifier
interventional
328
1 country
1
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2024
CompletedStudy Start
First participant enrolled
October 23, 2024
CompletedFirst Posted
Study publicly available on registry
October 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 24, 2024
October 1, 2024
2 months
October 23, 2024
October 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
converted to sinus rhythm
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
1 month
Secondary Outcomes (1)
Composite endpoint event of bradycardia, cardiovascular hospitalisation or death
1 month
Study Arms (2)
experimental group
EXPERIMENTALuse Amiodarone, Bisoprolol and Digoxin
control group
ACTIVE COMPARATORuse Bisoprolol and Digoxin
Interventions
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yumei Xuelead
- Beijing Anzhen Hospitalcollaborator
- Sir Run Run Shaw Hospitalcollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
- Zhongshan People's Hospital, Guangdong, Chinacollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Jiangmen Central Hospitalcollaborator
- Xiamen Cardiovascular Hospitalcollaborator
- Yan 'an Hospital of Kunming Citycollaborator
Study Sites (1)
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief physician of the first area of the heart
Study Record Dates
First Submitted
October 23, 2024
First Posted
October 24, 2024
Study Start
October 23, 2024
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
October 24, 2024
Record last verified: 2024-10