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

ConditionsAtrial FibrillationAnticoagulant Adverse ReactionStrokeMajor Adverse Cardiac Events
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • low-dose rivaroxaban

    Drug

    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 rivaroxaban

    Drug

    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)

Treatment groups

4,374 Participants
are divided into 2 treatment groups
Group A: Low-dose rivaroxabanExperimental treatment 1 intervention
Group B: Standard-dose rivaroxabanActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion, an estimated average of 2 years

Secondary outcomes

1

Bleeding events

A composite endpoint of ISTH major bleeding events and clinically relevant non major bleeding events was recorded after randomization

Time frame
Through study completion, an estimated average of 2 years
2

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

Time frame
Through study completion, an estimated average of 2 years
3

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

Time frame
Through study completion, an estimated average of 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

Source ClinicalTrials.gov
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