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Compares treatment options for Atrial Fibrillation
Official title Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation
ClinicalTrials.gov ID: NCT06108414
What this study is testing
What is low-dose rivaroxaban?
low-dose rivaroxaban is an investigational medicine, being studied as a potential treatment for atrial fibrillation.
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
- To evaluate the efficacy and safety of low-dose versus standard-dose rivaroxaban anticoagulation therapy in elderly patients with atrial fibrillation.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Transient ischemic attack (TIA) occurred within 3 days
- Transient atrial fibrillation due to reversible triggers (e.g., after cardiac surgery, pulmonary embolism, untreated hyperthyroidism)
See the full eligibility criteria
- 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
- 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...
- Transient ischemic attack (TIA) occurred within 3 days
- 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...
- 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...
- Severe renal impairment (estimated creatinine clearance ≤ 15 mL/min)
- Active liver disease Including but not limited to: i. 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.)...
- 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. 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.