An exploratory study of antithrombotic therapy with novel oral anticoagulants for atrial fibrillation patients with bioprosthetic valves

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000033729

Enrollment

Unknown

Registered

2020-06-11

Start date

2018-11-20

Completion date

Unknown

Last updated

2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation/flutter and bioprosthetic heart valves

Interventions

rivaroxaban:rivaroxaban 20mgQd or 15mg Qd

warfarin:warfarin(INR1.8-3.0)

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged >18 years at time of inclusion; 2. Patients with Persistent or Paroxysmal Atrial Fibrillation or flutter with bioprosthetic valves; 3. CHA2DS2-VAS>=1 in men or CHA2DS2-VAS>=2 in women; 4. The patient must be able to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Contraindications for anticoagulant therapy; 2. Ischemic stroke within one month; 3. History of hemorrhagic stroke; 4. Active hepatopathy or known significant liver disease or alanine aminotransferase N3× the upper limit of normal; 5. Severe renal dysfunction(Creatinine clearance <15ml/min) 6. Thrombolytic therapy within 48 hours prior to randomization; 7. Cardiac shock; 8. Major bleeding or active bleeding within one month; 9. History of hemorrhagic disorders; 10. Anemia(hemoglobin<10g/dl or platelet<100x10^9); 11. Pregnancy or breastfeeding or women of reproductive age not using effective contraceptive methods; 12. Life expectancy less than one year; 13. Participation in other ongoing study; 14. Difficulty in completing one-year follow-up; 15. Plans for radiofrequency ablation to remove atrial fibrillation; 16. Other conditions that investigators found not eligible for this trial; 17. Refusal to sign informed consent.

Design outcomes

Primary

Measure	Time frame
safety end point(includes all bleeding events during 12-month follow-up, including major bleeding,intracranial bleeding,clinically relevant non-major bleeding);	—

Secondary

Measure	Time frame
effectiveness end point(includes stroke and non-central nervous system systemic embolism during 12-month follow-up);	—

Countries

China

Contacts

Public ContactYang Yanmin

Fuwai Hospital, Chinese Academy of Medical Sciences

yymfuwai@163.com+86 13501241275

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026