Residual Vein Thrombosis Establishes the Optimal Duration of Oral Anticoagulants
DACUS
Residual Vein Thrombosis (RVT) Establishes the Optimal Duration of Oral Anticoagulants After a First Episode of Deep Vein Thrombosis of the Lower Limbs
1 other identifier
interventional
250
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2003
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 20, 2007
CompletedFirst Posted
Study publicly available on registry
February 22, 2007
CompletedFebruary 22, 2007
February 1, 2007
February 20, 2007
February 21, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Recurrent Venous Thromboembolism
major and minor haemorrhage
death
Interventions
Eligibility Criteria
You may qualify if:
- First episode of unprovoked and provoked proximal DVT of the lower limbs and treated for 3 month with oral anticoagulants
You may not qualify if:
- Active cancer,
- Limited life expectancy,
- Antiphospholipid antibody syndrome, or an other known thrombophilic status (such as antithrombin deficiency),
- Serious liver disease,
- Renal insufficiency (serum creatinine \> 2 mg/dL).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Siragusa S, Malato A, Anastasio R, Cigna V, Milio G, Amato C, Bellisi M, Attanzio MT, Cormaci O, Pellegrino M, Dolce A, Casuccio A, Bajardi G, Mariani G. Residual vein thrombosis to establish duration of anticoagulation after a first episode of deep vein thrombosis: the Duration of Anticoagulation based on Compression UltraSonography (DACUS) study. Blood. 2008 Aug 1;112(3):511-5. doi: 10.1182/blood-2008-01-131656. Epub 2008 May 22.
PMID: 18497320DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sergio Siragusa, MD
University Hospital of Palermo
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 20, 2007
First Posted
February 22, 2007
Study Start
November 1, 2003
Study Completion
September 1, 2006
Last Updated
February 22, 2007
Record last verified: 2007-02