Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age70+
SponsorChina National Center for Cardiovascular Diseases
About this trial
To evaluate the efficacy and safety of low-dose versus standard-dose rivaroxaban anticoagulation therapy in elderly patients with atrial fibrillation.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- low-dose rivaroxaban
- Standard-dose rivaroxaban
Treatment groups
4,374 Participants
are divided into 2 treatment groupsLocations
1National 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 College100037, BeijingBeijing Municipality, China
Sponsors and collaborators
China National Center for Cardiovascular Diseases
Lead sponsor
Source ClinicalTrials.gov