Absence of Residual Vein Thrombosis Permits to Withdrawn Oral Anticoagulants

NCT00623987 | Completed Phase 4 DMC

• 1 other identifier: 0036/99
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Background. The optimal duration of oral anticoagulant treatment in patients with idiopathic Deep Vein Thrombosis (DVT)of the lower limbs is still uncertain. Residual Vein Thrombosis (RVT) has been found able to establish the patient' risk for recurrent thrombotic events. In the present study we conducted a RVT-based therapeutic strategy, withholding OAT after 3 months in patients without RVT while continuing anticoagulants for at least additional 9 months in those in whom RVT persists. Methods Patients with a first episode of symptomatic unprovoked 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 (Group B), whereas those with RVT will continue OAT for at least additional 9 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.

Conditions

Deep Vein Thrombosis

Keywords

Residual vein thrombosis; Optimal duration; Oral anticoagulants

Outcome Measures

Primary Outcomes (1)

• Recurrent Venous Thromboembolism

  for the entire study

Secondary Outcomes (1)

• major and minor haemorrhage, death

  for the entire study

Study Arms (2)

A

ACTIVE COMPARATOR

warfarin treatment

Drug: warfarin accordingly INR value

B

NO INTERVENTION

withholding warfarin therapy

Interventions

warfarin accordingly INR value DRUG

warfarin accordingly to INR value between 2.0-3.0

Also known as: warfarin

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First episode of unprovoked 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,
• Pregnancy
• Conditions requiring anticoagulation (atrial fibrillation, etc)

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico: lead

Study Sites (1)

Sergio Siragusa

Palermo, 90127, Italy

Location

Related Publications (1)

• Siragusa S, Malato A, Saccullo G, Iorio A, Di Ianni M, Caracciolo C, Coco LL, Raso S, Santoro M, Guarneri FP, Tuttolomondo A, Pinto A, Pepe I, Casuccio A, Abbadessa V, Licata G, Battista Rini G, Mariani G, Di Fede G. Residual vein thrombosis for assessing duration of anticoagulation after unprovoked deep vein thrombosis of the lower limbs: the extended DACUS study. Am J Hematol. 2011 Nov;86(11):914-7. doi: 10.1002/ajh.22156. Epub 2011 Sep 22.

  PMID: 21953853 DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sergio Siragusa, MD

  University Hospital of Palermo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 26, 2008
• Study Start: June 1, 1999
• Primary Completion: June 1, 2006
• Study Completion: January 1, 2008
• Last Updated: March 25, 2008

Record last verified: 2008-03

Locations

IT (1)