An interventional study of NOAC discontinuation and NOAC continuation in Atrial Fibrillation (AF), sponsored by Beijing Anzhen Hospital. Recruiting at 22 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Treatment
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.
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).
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 4,100 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Beijing Anzhen Hospital is the lead sponsor of 192 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria:
Exclusion Criteria
Participants will be excluded if any of the following criteria are present:
Increased bleeding risk, including any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: NOAC discontinuation · Device: Smartwatch single-lead ECG monitoring
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.
Drug: NOAC continuation · Device: Smartwatch single-lead ECG monitoring
Stop NOACs immediately after randomization (experimental arm)
Continue guideline-recommended NOAC therapy after randomization (control arm)
Continuous AF screening with a smartwatch capable of recording single-lead ECG, with ECG confirmation required for diagnosis (PPG abnormalities alone are not diagnostic).
A composite of all-cause death, ischemic stroke, or systemic embolism
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).
Time frame: 48 months
ISTH major bleeding or ISTH clinically relevant non-major bleeding
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).
Time frame: 48 months
All-cause death
Time frame: 48 months
Ischemic stroke
Time frame: 48 months
Systemic embolism
Time frame: 48 months
Major bleeding
Time frame: 48 months
Clinically relevant non-major bleeding
Clinically relevant non-major bleeding is defined as any sign or symptom of hemorrhage that does not meet the criteria for the ISTH definition of major bleeding, but meets at least one of the following criteria: 1. Requiring medical intervention by a healthcare professional. 2. Leading to hospitalization or increased level of care. 3. Prompting a face-to-face evaluation by a healthcare provider.
Time frame: 48 months
Cardiovascular death
Time frame: 48 months
Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT) score
The AFEQT score ranges from 0 to 100, with higher scores indicating better QoL.
Time frame: 48 months
Atrial fibrillation Recurrence
Defined as atrial tachyarrhythmia lasting ≥30s on ECG
Time frame: 48 months
Five-Level EuroQol Five Dimensions Questionnaire (EQ-5D-5L) score
The EQ-5D-5L measures health-related quality of life. It has two parts: 1) a 5-dimension descriptive system (mobility, self-care, usual activities, pain, anxiety/depression) with 5 levels per dimension, generating a utility value; 2) a Visual Analogue Scale (VAS) from 0 (worst) to 100 (best) for overall health. Higher scores indicate better health.
Time frame: 48 months
Generalized Anxiety Disorder-7 item questionnaire (GAD-7) score
Anxiety is measured by GAD-7 score, with scores ranging from 0 to 21, where higher scores indicate greater levels of anxiety.
Time frame: 48 months
Patient Health Questionnaire-9 item questionnaire (PHQ-9) score
Depression is evaluated using PHQ-9 score, which is scored from 0 to 27, with a higher score indicating greater levels of depression.
Time frame: 48 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Dec 2029, 52 months after the start.
Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 52 months is above that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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