Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)

Assistance Publique - Hôpitaux de Paris

Status and phase: Terminated; Phase 3

Conditions: Venous Thromboembolism; Lung Neoplasm

Treatments: Drug: Tinzaparin Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT03090880

PHRC

2016-002546-23 (EudraCT Number)

P150963

Details and patient eligibility

About

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.

Full description

Adult patients aged ≥ 18 years with stage IV lung cancer and elevated D-dimer will be randomized to the experimental or control group.Patients in the control group will receive usual care, patients in the experimental group will receive subcutaneous tinzaparin once daily for six months. Follow-up visit will take place in outpatient clinic at day 90, day 180 and day 360. Blood sampling for biomarkers will be performed at inclusion visit and day 90.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Social security affiliation
• Written informed consent
• Histologically confirmed stage IV (M1a or M1b) non-small-cell lung cancer, including recurrent non-small-cell lung cancer after a period of complete remission
• D-dimer > 1,500 µg/L
• First line of systemic cancer treatment (chemotherapy, immunotherapy or targeted therapy), or new line of systemic cancer treatment for cancer progression (chemotherapy, immunotherapy or targeted therapy), introduced during the month preceding inclusion or planned within one month after inclusion
• ECOG (Eastern Cooperative Oncology Group) score 0-2
• Life expectancy >3 months

Exclusion criteria

• Hypersensitivity to heparin or to any excipients
• Septic endocarditis
• History of heparin-induced thrombocytopenia
• Ongoing anticoagulant treatment at therapeutic dosage
• VTE at inclusion
• Creatinin clearance <30 mL/min
• Active bleeding
• Platelet count < 100 G/L at inclusion
• Severe hepatic insufficiency
• Cancer treated exclusively with supportive care
• Aspirin at daily dosage > 160 mg
• Pregnancy
• Patient under tutorship or curatorship

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 2 patient groups

Control

No Intervention group

Description:

usual care,

Experimental

Experimental group

Description:

tinzaparin sodium

Treatment:

Drug: Tinzaparin Sodium