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

Stroke Clinical Trial

Official title:

The Efficacy and Safety of Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06108414
• Other study ID #: NCRC2022002
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Zhe Zheng, MD, PhD
• Phone: +86 010 88396051
• Email: zhengzhe[@]fuwai.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of low-dose versus standard-dose rivaroxaban anticoagulation therapy in elderly patients with atrial fibrillation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4306
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion criteria:

• Age =70 years
• Patients with atrial fibrillation (atrial fibrillation rhythm of at least 30 seconds duration recorded by ECG or Holter within 6 months)
• CHA2DS2-VASc score =2 in men and =3 in women

Exclusion criteria:

• Moderate-to-severe mitral stenosis or prior valve replacement surgery
• Severe stroke event within 6 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
• 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. iii. Gastrointestinal bleeding within the past year iv. Symptomatic or gastroscopic peptic ulcer within the last month v. Hemorrhagic constitution or coagulopathy vi. Use of fibrinolytic agents within 48 hours of enrollment vii. Difficult-controlled hypertension (180mm Hg systolic and/or 100 mm Hg diastolic) viii. Diagnosis of malignancy within 6 months or radiotherapy
• Transient atrial fibrillation due to reversible triggers (e.g., after cardiac surgery, pulmonary embolism, untreated hyperthyroidism)
• Catheter ablation or surgery for AF is planned
• Severe renal impairment (estimated creatinine clearance = 30 mL/min)
• Active infective endocarditis
• Active liver disease Including but not limited to: i. Persistent ALT, AST, Alk Phos > 2×U; ii. Known active hepatitis C (HCV RNA positive); iii. Active hepatitis B (HBs antigen +, anti-HBc IgM+); iv. Active hepatitis A
• anemia (hemoglobin level <100g/L) or thrombocytopenia (thrombocytopenia count <100 × 10^9/L)
• patients enrolled in another study drug trial within the past 30 days or at the same time
• Patients whose condition warrants standard-dose anticoagulation
• Other conditions deemed by the investigator to be inappropriate for enrollment

Related Conditions & MeSH terms

• Anticoagulant Adverse Reaction
• Atrial Fibrillation
• Cardiovascular Diseases
• Major Adverse Cardiac Events
• Stroke

Intervention

Drug:
• low-dose rivaroxaban
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
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular and cerebrovascular events(MACCE)	A composite endpoint of clinical events including cardiovascular death, myocardial infarction, stroke, and systemic embolism was recorded within 2 years after randomization	At 24-month after randomization
Secondary	Net clinical benefit	All-cause death, myocardial infarction, stroke, transient ischemic attack, systemic embolism, and major bleeding events within 2 years after randomization	At 24-month after randomization