Pinede study - description and results

Short oral anticoagulant course (3 months for proximal DVT and/or PE; 6 weeks for isolated calf DVT) by fluindione adjusted for INR range of 2.0 to 3.0

Remarks

randomization at the end of heparin therapy

Patients

Inclusion criteria

symptomatic thrombus below popliteal vein or proximal deep vein thrombosis and/or pulmonary embolism confirmed by positive Doppler ultrasonography or venography

Exclusion criteria

Pregnancy, breast feeding, previous venous thromboembolism, vena cava filter implantation, surgical thrombectomy, free-floating thrombus in the inferior vena cava lumen, deep vein thrombosis or pulmonary embolism whose diagnosis did not fulfill the predefined criteria, evolutionary cancer or malignant hematological disease, known biological thrombophilia, severe pulmonary embolism, pulmonary embolism treated by thrombolysis, myocardiopathy or other diseases justifying prolonged anticoagulation therapy, and liver insufficiency

Baseline characteristics

time of randomization

after heparin therapy

Method and design

Randomized effectives

NA / NA (studied vs. control)

Design

Parallel groups

Blinding

open

Follow-up duration

15 months after randomization�

Lost to follow-up

n=22

Number of centre

Geographic area

France

Primary endpoint

Recurrent VTE

Reference(s)

Trials register #

Pinede L, Ninet J, Duhaut P, Chabaud S, Demolombe-Rague S, Durieu I, Nony P, Sanson C, Boissel JP. Comparison of 3 and 6 months of oral anticoagulant therapy after a first episode of proximal deep vein thrombosis or pulmonary embolism and comparison of 6 and 12 weeks of therapy after isolated calf deep vein thrombosis.. Circulation 2001;103:2453-60

Pubmed | Hubmed | Fulltext

Pinede study, 2001

Treatments

Patients

Method and design

Results

Reference(s)