Condition: Atrial Fibrillation (AF) · Sponsor: Beijing Anzhen Hospital
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.
This description comes directly from the study's public registry record.
Liu He, PhD · 13810720787 · theliu@139.com
Caihua Sang, MD
Always discuss trial participation with your own doctor first.
| The First Affiliated Hospital of Anhui Medical University | Hefei, Anhui, China | Not Yet Recruiting |
| Beijing Anzhen Hospital | Beijing, Beijing Municipality, China | Recruiting |
| Guangdong Provincial People's Hospital | Guangzhou, Guangdong, China | Not Yet Recruiting |
| The Second Hospital of Hebei Medical University | Shijiazhuang, Hebei, China | Not Yet Recruiting |
| The First Affiliated Hospital of Harbin Medical University | Harbin, Heilongjiang, China | Not Yet Recruiting |
| The Second Affiliated Hospital of Harbin Medical University | Harbin, Heilongjiang, China | Not Yet Recruiting |
| Luohe Central Hospital | Luohe, Henan, China | Not Yet Recruiting |
| Henan Provincial Chest Hospital | Zhengzhou, Henan, China | Not Yet Recruiting |
| Wuhan Asia Heart Hospital | Wuhan, Hubei, China | Not Yet Recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan, Hubei, China | Not Yet Recruiting |
| The First Affiliated Hospital of Nanjing Medical University | Nanjing, Jiangsu, China | Not Yet Recruiting |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou, Jiangsu, China | Not Yet Recruiting |
+ 10 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06871228