Residual Vein Thrombosis Establishes the Optimal Duration of Oral Anticoagulants (DACUS)
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|ClinicalTrials.gov Identifier: NCT00438230|
Recruitment Status : Completed
First Posted : February 22, 2007
Last Update Posted : February 22, 2007
ABSTRACT Background The optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain . The present study addressed the possible role of the Residual Vein Thrombosis in assessing the need for a prolonged anticoagulation.
Methods Patients with a first episode of symptomatic unprovoked or provoked proximal Vein Thrombosis (VT) were given Oral Anticoagulant Treatment (OAT) for 3 months. Residual Vein Thrombosis (RVT), ultrasonographically-detected, will be then assessed. Patients without RVT did not continue OAT, whereas those with RVT will be randomized to either stop or continue OAT for 9 more months. Patients were followed-up prospectively focusing on the study outcomes: occurrence of recurrent venous thromboembolism and major bleeding over a period of at least 12 months after OAT discontinuation.
|Condition or disease||Intervention/treatment||Phase|
|Deep Vein Thrombosis||Drug: Warfarin||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Residual Vein Thrombosis (RVT) Establishes the Optimal Duration of Oral Anticoagulants After a First Episode of Deep Vein Thrombosis of the Lower Limbs|
|Study Start Date :||November 2003|
|Estimated Study Completion Date :||September 2006|
- Recurrent Venous Thromboembolism
- major and minor haemorrhage
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438230
|Study Chair:||Sergio Siragusa, MD||University Hospital of Palermo|