Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)

NCT03090880 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2022-11-17

No results posted yet for this study

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.

Conditions

  • Venous Thromboembolism
  • Lung Neoplasm

Interventions

DRUG

Tinzaparin Sodium

Subcutaneous tinzaparin 4,500 IU once daily for six months.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV
  • National Cancer Institute, France

    collaborator OTHER_GOV
  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Guy Meyer, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-14
Primary Completion
2021-08-18
Completion
2021-08-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03090880 on ClinicalTrials.gov