Clinical trial · Interventional
Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma
Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma: A Prospective, Multicenter, Open-Label, Randomized Trial
NCT06580223CI-TRIAL-00092317not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to evaluate the efficacy and safety of aspirin and rivaroxaban in thromboprophylaxis in Chinese MM patients at high risk for MM-associated VTE.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin 100mg | Drug | Aspirin | ALIAS |
| Rivaroxaban 10mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Aspirin
- description
- Aspirin,100mg qd, for six months
- interventionNames
- Drug: Aspirin 100mg
- type
- EXPERIMENTAL
- label
- Rivaroxaban
- description
- Rivaroxaban, 10mg qd, for six months
- interventionNames
- Drug: Rivaroxaban 10mg
Primary outcomes (1)
- measure
- Incidence of VTE within 6 months
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed multiple myeloma (according to Guidelines for the diagnosis and management of multiple myeloma in China (2022 revision)) 2. High risk of VTE (according to Expert consensus on the prevention and treatment of multiple myeloma related venous thromboembolism in China (2022)) 3. Life expectancy exceeding 12 months 4. Gender: not specified, Age: 18-90 years 5. Serum HIV antigen or antibody negative 6. HCV antibody negative, or HCV antibody positive with HCV RNA negative 7. Echocardiogram shows a left ventricular ejection fraction of ≥50% 8. Ability to sign an informed consent form Exclusion Criteria: 1. Pregnant women or women who are breastfeeding 2. Active gastrointestinal ulceration 3. Active bleeding 4. When initiating treatment, platelet count below 50 G/L, or with PT prolonged by more than 3 seconds, and APTT prolonged by more than 10 seconds. 5. Abnormal liver function (ALT or AST greater than 3 times the upper limit of normal, or total bilirubin greater than 2 times the upper limit of normal) 6. Abnormal renal function (creatinine clearance \< 30 mL/min) 7. Unable to cooperate in completing the clinical trial 8. Already enrolled in other clinical studies 9. Diagnosed with smoldering multiple myeloma or plasma cell leukemia 10. Patients already on antiplatelet therapy for other cardiovascular or cerebrovascular diseases.
References
Publications (0)
Data not yet available
No reference posted for this study.