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New treatment option for Atrial Fibrillation (AF)
Official title Discontinuation of Anticoagulation With Intensive Rhythm Monitoring in Post-ablation Patients With Atrial Fibrillation
ClinicalTrials.gov ID: NCT06871228
What this study is testing
What is NOAC discontinuation?
NOAC discontinuation is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for atrial fibrillation (af).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility criteria
- 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.
- 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 treatment clinical trial.
- Any condition that, in the investigator's judgment, would make the participant unsuitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Luohe, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Nanjing, Jiangsu, China
- Xuzhou, Jiangsu, China
- Changchun, Jilin, China
- Dalian, Liaoning, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Liaocheng, Shandong, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Shijiazhuang, Hebei, China; Harbin, Heilongjiang, China; Luohe, Henan, China and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.