drugset / Trial / NCT03090880
Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)
Phase 3
Terminated
59 enrolled
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France · collabNational Cancer Institute, France · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
Prospective randomized open multicenter trial with blinded adjudication of endpoints to assess the efficacy of six-month low-dose LMWH (Low Molecular Weight Heparin) for the prevention of symptomatic or incidental VTE in patients with stage IV lung cancer and elevated D-dimer.
Timeline
- Start
- 2018-09-14
- Primary completion
- 2021-08-18
- Completion
- 2021-08-18
Outcome
Outcome not reported
Stopped: “The rate of inclusion is too low to hope to reach the target of 800 patients. 59 patients were included, and their data will not meet the research objectives. The sponsor has decided to prematurely stop inclusions on January 13, 2022.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tinzaparin | Other / unclassified | 4500 iu | Subcutaneous |