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Study on the efficacy and safety of prophylactic anticoagulation therapy in high-risk heart failure patients

Study on the efficacy and safety of prophylactic anticoagulation therapy in high-risk heart failure patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062238
Enrollment
Unknown
Registered
2022-07-31
Start date
2022-07-30
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

heart failure

Interventions

Experimental group:Rivaroxaban 2.5mg bid
Control group:None

Sponsors

China-Japan Union Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Obtain written informed consent; 2. The presence of symptoms or signs of heart failure; 3. Aged >=18 years; 4. NYHA III-IV; 5. 25% 4 points.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to rivaroxaban or any excipients in tablets; 2. Atrial fibrillation; 3. Patients with acute myocardial infarction or PCI within six months, and patients currently receiving dual antiplatelet therapy; 4. Recent stroke (within 90 days), previous history of intracranial hemorrhage (including hemorrhagic stroke); 5. Patients with imaging evidence of thrombosis or embolism at the time of enrollment; 6. Other long-term anticoagulant indications: elective hip or knee replacement surgery recently (within 2 months); Patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) diagnosed within 6 months, or who are at high risk for recurrence of DVT or PE after 6 months; 7. Patients with valvular heart disease or after artificial valve replacement; 8. Patients receiving rivaroxaban within 28 days or currently receiving other anticoagulants (including oral, subcutaneous, intravenous, etc.); 9. Patients implanted with electrophysiological devices, patients who have recently or plan to undergo surgical treatment; 10. HAS-BLED>=4 for patients at high risk of bleeding; 11. eGFR < 20ml/min or being treated with hemofiltration or dialysis; 12. Patients with liver disease with coagulation abnormalities and clinically relevant bleeding risk, including patients with cirrhosis reaching Child Pugh B and C grades; 13. Use of CYP3A4 and P-gp potent inhibitors (including the antifungal ketoconazole and the HIV protease inhibitor ritonavir) or CYP4A3 potent inducers (including rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's wort); 14. Patients with anemia (hemoglobin < 10g/dL); 15. Patients with diseases other than heart failure that limit their expected survival to less than 6 months, including active malignancies; 16. Pregnant and lactating patients or patients planning to become pregnant.

Design outcomes

Primary

MeasureTime frame
Thromboembolic events;

Secondary

MeasureTime frame
Major adverse cardiovascular events;All-cause death + stroke + myocardial infarction;Hospitalization for heart failure;

Countries

China

Contacts

Public ContactYang Ping

China-Japan Union Hospital of Jilin University

pyang@jlu.edu.cn+86 13944111519

Outcome results

None listed

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