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Safety and efficacy of early use of DOACs in patients with atrial fibrillation combined with biovalve replacement: A multicenter, non-inferiority, open label, randomized controlled study

Safety and efficacy of early use of DOACs in patients with atrial fibrillation combined with biovalve replacement: A multicenter, non-inferiority, open label, randomized controlled study - Early anticoagulation study in patients with Atrial Fibrillation and bioprosthesis heart valve (EASY-AF)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093549
Enrollment
Unknown
Registered
2024-12-06
Start date
2024-12-06
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Atrial fibrillation

Interventions

Experimental group:DOACs
Control group:Warfarin

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged = 50 years, and <75 years at the time of inclusion; 2. Valvular heart disease with paroxysmal or persistent atrial fibrillation or atrial flutter more than 48 hours after biological valve replacement; 3. Sign informed consent;

Exclusion criteria

Exclusion criteria: 1. Presence of cardiovascular-related diseases, such as definite cardiac thrombosis, malignant tumor, active infective endocarditis or uncontrolled hypertension (>160/100mmHg); 2. Active internal bleeding or high risk of bleeding, such as major non-cardiac surgery or trauma in the past 30 days; 3. History of embolism with high bleeding risk, such as disabling stroke in the past 3 months, thromboembolic event, arteriovenous thrombosis or acute myocardial infarction event occurred 2 weeks before randomization; 4. Long-term use of aspirin >= 100 mg/day or bispecific antibody therapy, non-steroidal anti-inflammatory drugs or oral hormones is required for chronic medication; 5. Anemia HB 3 times the upper limit of normal, creatinine clearance rate <30 ml/min); 7. Those who participate in any kind of clinical trial of a drug that has not been officially approved for marketing by the state; 8. The investigator judged that the follow-up could not be completed;

Design outcomes

Primary

MeasureTime frame
Composite endpoints of Major cardiovascular events, haemorrhage events or deaths;

Secondary

MeasureTime frame
Composite end points of cardiac death or embolic events;Bleeding events;

Countries

China

Contacts

Public ContactHuihui Bao

The Second Affiliated Hospital of Nanchang University

huihui_bao77@126.com+86 791 86296098

Outcome results

None listed

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