Atrial FibrillationPhase 4NCT06108414
Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation
A Phase 4 study testing low-dose rivaroxaban and Standard-dose rivaroxaban in people with Atrial Fibrillation and Anticoagulant Adverse Reaction, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
To evaluate the efficacy and safety of low-dose versus standard-dose rivaroxaban anticoagulation therapy in elderly patients with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Atrial Fibrillation, Anticoagulant Adverse Reaction, Stroke
- What is being tested?
- low-dose rivaroxaban and Standard-dose rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,374 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥70 years
- Patients with atrial fibrillation (atrial fibrillation rhythm of at least 30 seconds duration recorded by ECG or Holter within 1 year)
- CHA2DS2-VASc score ≥2 in men and ≥3 in women
- Able to cooperate in signing ICFs
Who cannot join
- Moderate-to-severe mitral stenosis, or prior mechanical valve replacement surgery, or unresected atrial myxoma, or known left ventricular thrombus
- Prior biological valve replacement or valve repair surgery within 6 months
- Left ventricular assist device implantation status
- Severe stroke event within 3 months or any stroke within 14 days Major stroke events were defined as those with a Modified Rankin Scale score of 3-5.
- Score 3: moderately disabled, requiring some assistance but walking without assistance; Score 4: severe disability, unable to walk independently, unable to meet their own needs without the help of others; Score 5: severe disability, bedridden, incontinent, requiring ongoing care and attention
- Transient ischemic attack (TIA) occurred within 3 days
Show all 30Show fewer
- Transient atrial fibrillation due to reversible triggers (e.g., after cardiac surgery, pulmonary embolism, untreated hyperthyroidism)
- Prior or planning to undergo atrial fibrillation catheter ablation, drug cardioversion, electroconversion, or major surgery in 3 months; Prior catheter or surgical ablation > 3 months without atrial fibrillation electrocardiogram records
- Prior or planning to undergo left atrial appendage occlusion
- Active infective endocarditis
- High or increasing risk for bleeding i. Traumatic surgery that has been completed within the last 3 months or is planned within the next 3 months ii. Previous severe intracranial, intraocular, spinal cord, retroperitoneal, or nontraumatic intra-articular hemorrhage.
- Gastrointestinal bleeding within the past year iv. Symptomatic or gastroscopic peptic ulcer within the last month v. Hemorrhagic constitution or coagulopathy vi. Difficult-controlled hypertension (180mm Hg systolic and/or 100 mm Hg diastolic)
- Severe renal impairment (estimated creatinine clearance ≤ 15 mL/min)
- Active liver disease
- Including but not limited to:
- Persistent ALT, AST > 2×ULN; ii. TBil > 1.5×ULN; iii. Known active hepatitis A, B or C; iv. Cirrhosis
- Hemoglobin level <100g/L or thrombocytopenia count <100 × 10^9/L
- Having conditions warrant standard-dose or low-dose anticoagulation treatment (non-AF, such as VTE)
- Having conditions warrant warfarin anticoagulation treatment
- Daily dose of aspirin >100mg
- Having received dual antiplatelet therapy or intravenous antiplatelet drugs within 5 days (note: P2Y12 receptor antagonist alone or ≤ 100mg aspirin alone can be enrolled)
- Having received fibrinolysis treatment in 10 days or planning to use fibrinolytic drugs
- Having conditions warrant the following medications: CYP3A4 and P-gp inhibitors (itraconazole, ketoconazole, voriconazole, posaconazole, clarithromycin, erythromycin, fluconazole, ritonavir, dronedarone, etc.), selective serotonin reuptake inhibitors (SSRI)/serotonin norepinephrine reuptake inhibitors (SNRI) drugs (fluoxetine, paroxelin, etc.) CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort, etc.), long-term use of NSAIDs
- Having allergic or adverse reactions to any excipients (including but not limited to lactose, starch, etc.) in rivaroxaban tablets, including but not limited to hereditary lactose or galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.
- Having diagnosed with malignant tumors within 6 months, or receiving radiotherapy/chemotherapy, with an expected lifespan of no more than 3 years
- Antiphospholipid syndrome
- Having been enrolled in another interventional clinical trial within the past 30 days or at the same time
- Mental disorders, communication barriers, cognitive impairment, or other serious illnesses that may affect the participation in this study
- Known poor adherence to study follow-up or taking study drugs
- Other conditions deemed by the investigator to be inappropriate for enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100037
Zhe Zheng, Professor, 010-88396051, zhengzhe@fuwai.com
About this study
Official title: The Efficacy and Safety of Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation
To evaluate the efficacy and safety of low-dose versus standard-dose rivaroxaban anticoagulation therapy in elderly patients with atrial fibrillation.
- Being tested
- low-dose rivaroxaban, Standard-dose rivaroxaban
- Medical subject headings
- Atrial Fibrillation, Stroke, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose rivaroxabanDrug
Rivaroxaban 15mg q.d. (The dose should be reduced to 10mg q.d. in the following special populations: 1. Creatinine clearance <50 mL/min; 2. Body weight ≤60kg; 3. Age ≥80 years old)
Standard-dose rivaroxabanDrug
Rivaroxaban 20mg q.d. (The dose should be reduced to 15mg q.d. in the following special populations: 1. Creatinine clearance <50 mL/min; 2. Body weight ≤60kg; 3. Age ≥80 years old)
| Study group | Role | What they receive |
|---|---|---|
| Low-dose rivaroxaban | Experimental | 15mg q.d. rivaroxaban for 2 years after randomization. The dose should be reduced in the following special conditions: 1. Creatinine clearance <50 mL/min; 2. Body weight ≤60kg; 3. Age ≥80 years old. In the low-dose group, the dose was reduced from the usual 15mg q.d. to 10mg q.d. . Receives: Drug: low-dose rivaroxaban |
| Standard-dose rivaroxaban | Active comparator | 20mg q.d. rivaroxaban for 2 years after randomization. The dose should be reduced in the following special conditions: 1. Creatinine clearance <50 mL/min; 2. Body weight ≤60kg; 3. Age ≥80 years old. In the standard-dose group, the dose was reduced from the 20mg q.d. to 15mg q.d. . Receives: Drug: Standard-dose rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular and cerebrovascular events(MACCE)
A composite endpoint of clinical events including cardiovascular death, myocardial infarction, stroke, and systemic embolism was firstly recorded after randomization
Measured: Through study completion, an estimated average of 2 years
Secondary outcomes (3)
Bleeding events
A composite endpoint of ISTH major bleeding events and clinically relevant non major bleeding events was recorded after randomization
Measured: Through study completion, an estimated average of 2 years
Net clinical benefit
A composite endpoint of all-cause death, myocardial infarction, stroke, transient ischemic attack, systemic embolism, ISTH major bleeding events and clinically relevant non major bleeding events after randomization
Measured: Through study completion, an estimated average of 2 years
Components of all primary and secondary outcome measures
All-cause death, myocardial infarction, stroke, transient ischemic attack, systemic embolism, ISTH major bleeding events and clinically relevant non major bleeding events after randomization
Measured: Through study completion, an estimated average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108414
- Sponsor's protocol ID
- NCRC2022002
- Status last verified
- Sep 2024
- First submitted
- 25 Oct 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Han J, Qi W, Yuan S, Liu H, Wang Y, Zhang H, Liu J, Zhao Y, Zhang Y, Zheng L, Yao Y, Zheng Z. Efficacy and safety of low-dose rivaroxaban in elderly patients with atrial fibrillation for oral anticoagulation therapy: Rationale, design, and study protocol for a multicenter randomized controlled trial (SAFE-AF). Am Heart J. 2025 Dec;290:268-277. doi: 10.1016/j.ahj.2025.07.011. Epub 2025 Jul 15.
PubMed 40675206
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06108414
- Acronym / sponsor ID
- NCRC2022002
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,374 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of low-dose versus standard-dose rivaroxaban anticoagulation therapy in elderly patients with atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose rivaroxaban | Experimental | Drug: low-dose rivaroxaban15mg q.d. rivaroxaban for 2 years after randomization. The dose should be reduced in the following special conditions: 1. Creatinine clearance <50 mL/min; 2. Body weight ≤60kg; 3. Age ≥80 years old. In the low-dose group, the dose was reduced from the usual 15mg q.d. to 10mg q.d. . |
| Standard-dose rivaroxaban | Active comparator | Drug: Standard-dose rivaroxaban20mg q.d. rivaroxaban for 2 years after randomization. The dose should be reduced in the following special conditions: 1. Creatinine clearance <50 mL/min; 2. Body weight ≤60kg; 3. Age ≥80 years old. In the standard-dose group, the dose was reduced from the 20mg q.d. to 15mg q.d. . |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥70 years
- Patients with atrial fibrillation (atrial fibrillation rhythm of at least 30 seconds duration recorded by ECG or Holter within 1 year)
- CHA2DS2-VASc score ≥2 in men and ≥3 in women
- Able to cooperate in signing ICFs
Key exclusion criteria (30 listed)
- Moderate-to-severe mitral stenosis, or prior mechanical valve replacement surgery, or unresected atrial myxoma, or known left ventricular thrombus
- Prior biological valve replacement or valve repair surgery within 6 months
- Left ventricular assist device implantation status
- Severe stroke event within 3 months or any stroke within 14 days Major stroke events were defined as those with a Modified Rankin Scale score of 3-5.
- Score 3: moderately disabled, requiring some assistance but walking without assistance; Score 4: severe disability, unable to walk independently, unable to meet their own needs without the help of others; Score 5: severe disability, bedridden, incontinent, requiring ongoing care and attention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-dose rivaroxabanRivaroxaban 15mg q.d. (The dose should be reduced to 10mg q.d. in the following special populations: 1. Creatinine clearance <50 mL/min; 2. Body weight ≤60kg; 3. Age ≥80 years old) | Drug | Low-dose rivaroxaban |
| Standard-dose rivaroxabanRivaroxaban 20mg q.d. (The dose should be reduced to 15mg q.d. in the following special populations: 1. Creatinine clearance <50 mL/min; 2. Body weight ≤60kg; 3. Age ≥80 years old) | Drug | Standard-dose rivaroxaban |
Primary outcome
Major adverse cardiovascular and cerebrovascular events(MACCE)
Time frame: Through study completion, an estimated average of 2 years
A composite endpoint of clinical events including cardiovascular death, myocardial infarction, stroke, and systemic embolism was firstly recorded after randomization
3 secondary outcomes
Bleeding events
Time frame: Through study completion, an estimated average of 2 years
Net clinical benefit
Time frame: Through study completion, an estimated average of 2 years
Components of all primary and secondary outcome measures
Time frame: Through study completion, an estimated average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40675206Han J, Qi W, Yuan S, Liu H, Wang Y, Zhang H, Liu J, Zhao Y, Zhang Y, Zheng L, Yao Y, Zheng Z. Efficacy and safety of low-dose rivaroxaban in elderly patients with atrial fibrillation for oral anticoagulation therapy: Rationale, design, and study protocol for a multicenter randomized controlled trial (SAFE-AF). Am Heart J. 2025 Dec;290:268-277. doi: 10.1016/j.ahj.2025.07.011. Epub 2025 Jul 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing low-dose rivaroxaban and Standard-dose rivaroxaban in people with Atrial Fibrillation and Anticoagulant Adverse Reaction, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhe Zheng, MD, PhD (+86 010 88396051, zhengzhe@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular and cerebrovascular events(MACCE) (time frame: Through study completion, an estimated average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06108414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.