DIscontinuation of Anticoagulation With Intensive Rhythm MONitoring CompareD With Continuous Anticoagulation in Post-ablation Patients With Atrial Fibrillation: A Randomized Controlled Trial

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

DIAMOND-AF is a multicenter, randomized, open-label trial evaluating whether discontinuing oral anticoagulation after successful atrial fibrillation ablation can reduce bleeding risk without increasing death or thromboembolism risks. Adults aged 18-80 years, 60-365 days post-ablation, with CHA2DS2-VA ≥2, no prior stroke/TIA/systemic embolism, continuous NOAC use, and no documented atrial tachyarrhythmia recurrence will be randomized 1:1 to stop NOACs immediately or to continue NOAC therapy. All participants use intensified rhythm surveillance including smartwatch ECG and Holter/patch monitoring (at least every 6 months; every 2 months encouraged) to detect recurrence. Co-primary endpoints are (1) non-inferiority for the composite of all-cause death, ischemic stroke, or systemic embolism and (2) superiority for the composite of ISTH major bleeding or ISTH clinically relevant non-major bleeding. The planned sample size is 4,100 participants.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ Participants must meet all of the following criteria:

• Age 18 to 80 years.

• 60±15 to 365±15 days after atrial fibrillation/atrial flutter (AF/AFL) ablation.

• CHA2DS2-VA score ≥2.

• No history of stroke, transient ischemic attack (TIA), or systemic embolism.

• Continuous use of a NOAC since AF/AFL ablation.

• No documented atrial tachyarrhythmia recurrence since ablation.

• No antiarrhythmic drug (AAD) use within the past 2 months.

• Able and willing to provide written informed consent.

• Able and willing to comply with study procedures and follow-up.

Locations
Other Locations
China
Beijing Anzhen Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Chengdu Fifth People's Hospital
NOT_YET_RECRUITING
Chengdu
First Affiliated Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
The Second Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Liaocheng Heart Hospital
NOT_YET_RECRUITING
Liaocheng
Liaocheng People's Hospital
NOT_YET_RECRUITING
Liaocheng
Luohe Central Hospital
NOT_YET_RECRUITING
Luohe
The First Affiliated Hospital of Nanjing Medical University
NOT_YET_RECRUITING
Nanjing
Shengjing Hospital Affiliated to China Medical University
NOT_YET_RECRUITING
Shenyang
The Second Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Wuhan Asia Heart Hospital
NOT_YET_RECRUITING
Wuhan
The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING
Xuzhou
Henan Provincial Chest Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Liu He, PhD
theliu@139.com
13810720787
Backup
Caihua Sang, MD
Time Frame
Start Date: 2025-08-05
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 4100
Treatments
Experimental: Discontinuation of NOACs
Participants randomized to the experimental arm will stop oral anticoagulation (NOACs) immediately after randomization. All participants in this trial (including this arm) will undergo intensified rhythm surveillance using a smartwatch capable of single-lead ECG plus scheduled Holter or single-lead ECG patch monitoring (at least every 6 months; every 2 months encouraged), with symptom-triggered and opportunistic ECGs. AF recurrence is defined as ECG-documented AF/AFL/atrial tachycardia lasting ≥30 seconds.
Active_comparator: Continuation of NOACs
Participants randomized to the control arm will continue NOAC therapy after randomization. The same intensified rhythm monitoring approach (smartwatch ECG plus scheduled Holter/patch and symptom/opportunistic ECG confirmation) applies.
Related Therapeutic Areas
Sponsors
Leads: Beijing Anzhen Hospital

This content was sourced from clinicaltrials.gov