DIscontinuation of Anticoagulation With Intensive Rhythm MONitoring CompareD With Continuous Anticoagulation in Post-ablation Patients With Atrial Fibrillation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,100
- 试验地点
- 22
- 主要终点
- A composite of all-cause death, ischemic stroke, or systemic embolism
研究概览
简要总结
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.
详细描述
DIAMOND-AF is an investigator-initiated, multicenter, randomized, open-label, parallel-group trial designed to evaluate post-catheter ablation anticoagulation management in patients with atrial fibrillation (AF/AFL). The trial will enroll adults aged 18-80 years who are 60±15 to 365±15 days after AF ablation, have a CHA2DS2-VA score ≥2, have no history of ischemic stroke/transient ischemic attack/systemic embolism, have been continuously taking a non-vitamin K antagonist oral anticoagulant (NOAC), and have no documented atrial tachyarrhythmia recurrence after ablation. Eligible participants will be randomized 1:1 to (1) discontinue NOAC immediately after randomization or (2) continue NOAC therapy. The study uses a co-primary endpoint strategy: a non-inferiority assessment for the composite efficacy endpoint (all-cause death, ischemic stroke, or systemic embolism) and a superiority assessment for the composite safety endpoint (ISTH major bleeding or ISTH clinically relevant non-major bleeding). To maximize safety while testing an anticoagulation-discontinuation strategy, all participants will undergo intensified rhythm monitoring using a smartwatch capable of single-lead ECG plus scheduled Holter/single-lead ECG patch monitoring (at least every 6 months; every 2 months encouraged), with symptom-triggered and opportunistic ECGs incorporated. AF Recurrence is defined as any ECG-confirmed atrial tachyarrhythmia (AF/AFL/atrial tachycardia) lasting ≥30 seconds; once AF recurrence is confirmed, the participant will be censored and will exit further trial follow-up. Participants will have in-person/structured study visits at months 3 and 6 after randomization, then every 6 months, with additional rhythm/anticoagulation follow-up every 2 months. The planned sample size is 4,100 participants (2,050 per group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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.
排除标准
- •Participants will be excluded if any of the following criteria are present:
- •High risk of post-ablation recurrence (e.g. including premature atrial contraction burden >3% on any ambulatory ECG/Holter recording).
- •Moderate-to-severe mitral stenosis (mitral valve area ≤2.0 cm²) or mechanical heart valve.
- •Increased bleeding risk, including any of the following:
- •Current ISTH major bleeding or clinically relevant non-major bleeding (CRNMB).
- •History of non-traumatic major bleeding (e.g., intracranial, intraocular, spinal, retroperitoneal, gastrointestinal, or intra-articular) unless the reversible cause has been permanently eliminated.
- •Unresolved intracranial aneurysm/vascular malformation, or active/unhealed gastric or duodenal ulcer.
- •General anesthesia surgery within the past 3 months.
- •Planned surgery within the next 3 months.
- •Known bleeding diathesis (e.g., hemophilia).
- •Uncontrolled hypertension (SBP >180 mmHg and/or DBP >110 mmHg).
- •Hemoglobin <90 g/L or blood transfusion within 4 weeks prior to enrollment.
- •Platelet count <50 × 10⁹/L.
- •End-stage kidney disease (eGFR <15 mL/min/1.73 m²) or on dialysis.
- •Severe liver disease (e.g., esophageal variceal bleeding, ascites, hepatic encephalopathy, or jaundice).
- •Known intolerance to oral anticoagulants or contraindication to oral anticoagulation.
- •Any condition requiring continued oral anticoagulation (e.g., pulmonary embolism, deep vein thrombosis, hypertrophic cardiomyopathy, cardiac amyloidosis).
- •Conditions associated with high non-cardioembolic stroke risk, including carotid, vertebral, or intracranial arterial stenosis ≥70%.
- •Prior left atrial appendage (LAA) occlusion, surgical LAA excision/closure, or intraoperative confirmation of LAA electrical isolation.
- •Female participants who are pregnant or breastfeeding, or of childbearing potential not using effective contraception.
- •Life expectancy <2 years.
- •Current participation in another interventional clinical trial.
- •Any condition that, in the investigator's judgment, would make the participant unsuitable for the study.
研究组 & 干预措施
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.
干预措施: Smartwatch single-lead ECG monitoring (Device)
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.
干预措施: NOAC continuation (Drug)
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.
干预措施: Smartwatch single-lead ECG monitoring (Device)
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.
干预措施: NOAC discontinuation (Drug)
结局指标
主要结局
A composite of all-cause death, ischemic stroke, or systemic embolism
时间窗: 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
时间窗: 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).
次要结局
- Ischemic stroke(48 months)
- Atrial fibrillation Recurrence(48 months)
- Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT) score(48 months)
- Systemic embolism(48 months)
- Cardiovascular death(48 months)
- Major bleeding(48 months)
- All-cause death(48 months)
- Clinically relevant non-major bleeding(48 months)
- Five-Level EuroQol Five Dimensions Questionnaire (EQ-5D-5L) score(48 months)
- Generalized Anxiety Disorder-7 item questionnaire (GAD-7) score(48 months)
- Patient Health Questionnaire-9 item questionnaire (PHQ-9) score(48 months)