Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis.

Detailed Description
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The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin)administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants given for a similar period of time in patients with proximal venous thrombosis.

Official Title
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Phase IV, Randomized, Open-Label Trial Comparing Long-Term Subcutaneous Low-Molecular Weight Heparin With Oral Anticoagulant Therapy in the Treatment of Deep Venous Thrombosis

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Drug: tinzaparin
* Drug: acenocoumarol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive, symptomatic patients with a first or recurrent episode of acute proximal-vein thrombosis of the lower limbs. either sex and over 18 years of age referred to the Vascular Surgery Department of the hospital onset of symptoms less than 2 weeks documented by compression ultrasonography, Exclusion Criteria: received heparin, low-molecular-weight heparin or oral anticoagulant therapy for more than 2 days for the present disease pulmonary embolism requiring thrombolytic therapy Need of surgical thrombectomy or vena cava interruption receiving oral anticoagulant treatment or antiplatelet agents for other conditions contraindication to anticoagulant treatment (active bleeding, severe blood pressure or allergy to the study drugs) platelet count lower than 100x103 /μl or hemoglobin concentration lower than 7 g/dl or history of heparin-associated thrombocytopenia severe renal failure necessitating dialysis pregnancy lumbar puncture within the previous 24 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tinzaparin<br>tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months. | Drug: tinzaparin<br>* tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months<br>* Other names: innohep;|
| Active Comparator: acenocoumarol<br>tinzaparin for 1 weeks followed by acenocoumarol for 6 months | Drug: acenocoumarol<br>* tinzaparin subcutaneously 175 IU anti-Xa/kg of body weight once daily for 7 days followed by acenocoumarol for 6 months<br>* Other names: Vitamin K antagonists;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic recurrent venous thromboembolism |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of major bleeding |  | 6 month treatment interval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous thromboembolism, low molecular weight heparin, Vitamin K antagonist, Longterm