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Efficacy and Safety of rivaroxaban or warfarin on venous thromboembolic disease: A Randomized controlled trial

Study for efficacy and Safety of rivaroxaban or warfarin on venous thromboembolic disease

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14005223
Enrollment
Unknown
Registered
2014-09-12
Start date
2014-09-12
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

venous thromboembolic disease

Interventions

Warfarin group:Warfarin

Sponsors

State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Diseases, First Affiliated Hospital of Guangzhou Medical University, Guangzhou,Guangdong, China
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with non-high-risk pulmonary thromboembolism with/without deep vein thrombosis; 2.Patients volunteered for this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with active bleeding or the high risk for bleeding complications; 2. Patients who were considered to be high-risk pulmonary thromboembolism; 3. With both aspartate aminotransferase (AST) and glutamic-pyruvic transaminase (ALT) more than three times of the upper limit of normal in liver function test and Ccr less than 30ml/min in kidney function test; 4. Those with systemic blood pressure lower than 90/50 mmHg, or those uncontrolled dangerous hypertension(BP higher than 170/110 mmHg); 5. Patients who have to take azole antifungals, HIV protease inhibitors or strong CYP3A4 inducers during the period of treatment; 6. Pregnant, lactational women or may be pregnant during the period of treatment.

Design outcomes

Primary

MeasureTime frame
Computed Tomography Pulmonary Angiography;Bleeding events;Thromboembolic events;Warfarin VKORC1 and CYP2C9 gen;

Secondary

MeasureTime frame
liver and kidney functions;echocardiography;Lower extremity venous ultrasound;Ventilation/perfusion scan;

Countries

China

Contacts

Public ContactChunli Liu
chunli@gird.cn+86 13560158649

Outcome results

None listed

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