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Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation

StatusRecruiting
PhasePhase 4
Started2024-09-01
View on ClinicalTrials.gov ↗

Amendment history

2024-09-11
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-08-01→confirmed 2024-09-01
Study sites0→1
2024-07-16
Study Status v3
Start date2024-07-01→2024-08-01
2024-06-18
Study Status v2
Start date2024-06-01→2024-07-01
2024-05-27
Study Status, Study Design, Outcome Measures, Eligibility v1
Start date2024-01-01→2024-06-01
Enrollment target4306→4374
Eligibility criteria+1,836 characters
[...] least 30 seconds duration recorded by ECG or Holter within 61 monthsyear) CHA2DS2-VASc score ≥2 in men and ≥3 in women Able to cooperate in signing ICFs Exclusion criteria： 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 63 months or any stroke within 14 days Major stroke events wer [...] edridden, incontinent, requiring ongoing care and attention Tran [...] [...]
Secondary endpoints1 to 3 entries
Bleeding events Components of all primary and secondary outcome measures
2023-10-25
Original filing
To evaluate the efficacy and safety of low-dose versus standard-dose rivaroxaban anticoagulation therapy in elderly patients with atrial fibrillation.
Trial Details
NCT Number NCT06108414
Lead Sponsor China National Center for Cardiovascular Diseases
Conditions Atrial Fibrillation, Anticoagulant Adverse Reaction, Stroke, Major Adverse Cardiac Events
Enrollment 4,374 participants
Start Date 2024-09-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-09-19