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

NCT ID: NCT06657404

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-23

Study Completion Date

2024-12-31

Brief Summary

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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)

Detailed Description

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Conditions

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Atrial Fibrillation (AF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental group

use Amiodarone, Bisoprolol and Digoxin

Group Type EXPERIMENTAL

use Amiodarone, Bisoprolol and Digoxin

Intervention Type 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.

control group

use Bisoprolol and Digoxin

Group Type ACTIVE_COMPARATOR

use Amiodarone, Bisoprolol and Digoxin

Intervention Type 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.

Interventions

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use Amiodarone, Bisoprolol and Digoxin

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Jiangmen Central Hospital

OTHER

Sponsor Role collaborator

Xiamen Cardiovascular Hospital

UNKNOWN

Sponsor Role collaborator

Yan 'an Hospital of Kunming City

UNKNOWN

Sponsor Role collaborator

Yumei Xue

OTHER

Sponsor Role lead

Responsible Party

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Yumei Xue

Chief physician of the first area of the heart

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yumei Xue, phD

Role: CONTACT

13570082363

Facility Contacts

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Yumei Xue, phD

Role: primary

13570082363

Haowei Chen, master

Role: backup

13026740170

Other Identifiers

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202332

Identifier Type: -

Identifier Source: org_study_id

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