Discontinuation of Anticoagulation With Intensive Rhythm Monitoring in Post-ablation Patients With Atrial Fibrillation

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Препарат NOAC discontinuation
  Stop NOACs immediately after randomization (experimental arm)
• Препарат NOAC continuation
  Continue guideline-recommended NOAC therapy after randomization (control arm)
• Устройство 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).

Первичные конечные точки

• A composite of all-cause death, ischemic stroke, or systemic embolism [Срок оценки: 48 months]
• ISTH major bleeding or ISTH clinically relevant non-major bleeding [Срок оценки: 48 months]

Вторичные конечные точки (11)

• All-cause death [Срок оценки: 48 months]
• Ischemic stroke [Срок оценки: 48 months]
• Systemic embolism [Срок оценки: 48 months]
• Major bleeding [Срок оценки: 48 months]
• Clinically relevant non-major bleeding [Срок оценки: 48 months]
• Cardiovascular death [Срок оценки: 48 months]
• Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT) score [Срок оценки: 48 months]
• Atrial fibrillation Recurrence [Срок оценки: 48 months]
• Five-Level EuroQol Five Dimensions Questionnaire (EQ-5D-5L) score [Срок оценки: 48 months]
• Generalized Anxiety Disorder-7 item questionnaire (GAD-7) score [Срок оценки: 48 months]
• Patient Health Questionnaire-9 item questionnaire (PHQ-9) score [Срок оценки: 48 months]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 22 центра

• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• Beijing Anzhen Hospital — Пекин
• Guangdong Provincial People's Hospital — Гуанчжоу
• The Second Hospital of Hebei Medical University — Shijiazhuang
• The First Affiliated Hospital of Harbin Medical University — Харбин
• The Second Affiliated Hospital of Harbin Medical University — Харбин
• Luohe Central Hospital — Luohe
• Henan Provincial Chest Hospital — Чжэнчжоу
• … и ещё 14 центров

Идентификаторы

NCT: NCT06871228 · 2025KLS09

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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