Discontinuation of Anticoagulation With Intensive Rhythm Monitoring in Post-ablation Patients With Atrial Fibrillation
Condition(s) studied
Investigational drug(s) / intervention(s)
NOAC discontinuation: Stop NOACs immediately after randomization (experimental arm)
NOAC continuation: Continue guideline-recommended NOAC therapy after randomization (control arm)
Smartwatch single-lead ECG monitoring: Continuous AF screening with a smartwatch capable of recording single-lead ECG, with ECG confirmation required for diagnosis (PPG abnormalities alone are not diagnostic).
Study 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
Primary outcome measure(s)
- A composite of all-cause death, ischemic stroke, or systemic embolism — 48 months
The primary effectiveness outcome is to determine whether NOAC discontinuation with intensified rhythm monitoring is non-inferior to continued NOAC therapy for the composite of all-cause death, ischemic stroke, or systematic embolism. Ischemic stroke is defined as an acute focal dysfunction from CNS infarction lasting ≥24h, with potential hemorrhagic transformation. Systemic embolism refers to arterial embolism or thrombosis (excluding stroke or TIA). - ISTH major bleeding or ISTH clinically relevant non-major bleeding — 48 months
The primary safety outcome is to determine whether NOAC discontinuation is superior to continued NOAC therapy in reducing the composite of ISTH major bleeding or ISTH clinically relevant non-major bleeding (CRNMB). ISTH major bleeding and CRNMB are defined per ISTH criteria (e.g., fatal bleeding; critical-site bleeding; hemoglobin drop ≥20 g/L or transfusion ≥2 units for major bleeding; and medically attended, hospitalization-escalating, or unplanned-visit bleeding for CRNMB).
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | Not Yet Recruiting |
| Beijing Anzhen Hospital | Beijing | Beijing Municipality | Recruiting |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | Not Yet Recruiting |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | Not Yet Recruiting |
| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | Not Yet Recruiting |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | Not Yet Recruiting |
| Luohe Central Hospital | Luohe | Henan | Not Yet Recruiting |
| Henan Provincial Chest Hospital | Zhengzhou | Henan | Not Yet Recruiting |
| Wuhan Asia Heart Hospital | Wuhan | Hubei | Not Yet Recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Not Yet Recruiting |
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | Not Yet Recruiting |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | Not Yet Recruiting |
| The First Hospital of Jilin University | Changchun | Jilin | Not Yet Recruiting |
| First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | Not Yet Recruiting |
| Shengjing Hospital Affiliated to China Medical University | Shenyang | Liaoning | Not Yet Recruiting |
| Qilu Hospital of Shandong University | Jinan | Shandong | Not Yet Recruiting |
| Liaocheng People's Hospital | Liaocheng | Shandong | Not Yet Recruiting |
| Liaocheng Heart Hospital | Liaocheng | Shandong | Not Yet Recruiting |
| Chengdu Fifth People's Hospital | Chengdu | Sichuan | Not Yet Recruiting |
| The First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | Not Yet Recruiting |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | Not Yet Recruiting |
| Ningbo No.2 Hospital | Ningbo | Zhejiang | Not Yet Recruiting |
More Beijing Anzhen Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06871228 on ClinicalTrials.gov ↗ ← All trials in China