Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)

Venous Thromboembolism Clinical Trial

— PROVE  

Official title:

Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03090880
• Other study ID #: P150963
• Secondary ID: 2016-002546-23PH
• Status: Terminated
• Phase: Phase 3
• Start date: September 14, 2018
• Est. completion date: August 18, 2021

Study information

• Verified date: December 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: August 18, 2021
• Est. primary completion date: August 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Tinzaparin Sodium
Subcutaneous tinzaparin 4,500 IU once daily for six months.

Locations

Country	Name	City	State
France	Centre Hospitalier Annecy Genevois	Annecy	Rhône Alpes
France	Hôpital Avicenne, Hôpitaux universitaires Paris Seine-	Bobigny	Ile De France
France	CHU de Caen	Caen	Normandie
France	Hôpital d'Instruction des Armées Percy	Clamart	Ile De France
France	Hôpital Louis Mourier	Colombes	Ile De France
France	Centre Hospitalier Intercommunal de Créteil	Créteil	Ile De France
France	Centre Hospitalier de Versailles André Mignot	Le Chesnay	Ile De France
France	Hôpital Bicêtre	Le Kremlin Bicêtre	Ile De France
France	Centre Oscar Lambret	Lille	Hauts De France
France	Groupement Hospitalier Est Hospices civils de Lyon	Lyon	Rhônes Alpes
France	Centre Hospitalier régional d'Orléans	Orléans	Centre
France	Centre Hospitalier Paris Saint-Joseph	Paris	Ile De France
France	Hôpital Bichat Claude Bernard	Paris	Ile De France
France	Hôpital Européen Georges Pompidou	Paris	Ile De France
France	Hôpital Pitié Salpétrière	Paris	Ile De France
France	Hôpital Tenon	Paris	Ile De France
France	Institut Curie	Paris	Ile De France
France	Institut Mutualiste Montsouris	Paris	Ile De France
France	CHU Poitiers	Poitiers	Nouvelle-Aquitaine
France	Hôpital Pontchaillou	Rennes	Bretagne
France	CHU de Rouen, Hôpital Charles Nicolle	Rouen	Seine Maritime
France	Centre cardiologique du Nord	Saint Denis	Ile De France
France	Institut de cancérologie de l'Ouest	Saint Herblain	Pays De La Loire
France	Institut de Cancérologie Lucien Neuwirth	Saint Priest	Rhônes-Alpes
France	Hôpital Foch	Suresnes	Ile De France
France	Hôpital Larrey	Toulouse	Languedoc-Roussillon-Midi-Pyrénées
France	Gustave Roussy	Villejuif	Ile De France

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France, National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Risk factors for venous thromboembolism	Risk factors for venous thromboembolism	12 months
Primary	venous thromboembolic events	All venous thromboembolism (VTE) events during the six-month treatment period including: objectively confirmed symptomatic pulmonary embolism (PE),; objectively confirmed symptomatic lower-limb deep vein thrombosis (DVT) (including iliac and caval thrombosis),; objectively confirmed symptomatic upper extremity DVT,; objectively confirmed incidentally diagnosed PE or proximal DVT; death due to PE.	6 months
Secondary	Symptomatic VTE events	Objectively confirmed symptomatic VTE and death due to PE	6 months
Secondary	Venous thromboembolic events	Objectively confirmed symptomatic or incidental VTE during the 12-months study period	12 months
Secondary	Major bleedings	Major bleeding according to the ISTH criteria	6 months
Secondary	Death	Overall mortality and causes of death	6 months
Secondary	Death	Overall mortality and causes of death	12 months