Ultrasound Findings to Adjust the Duration of Anticoagulation

NCT00380120 | Completed Phase 3 DMC

• 1 other identifier: 10/98
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective controlled randomized clinical trial. Consecutive patients with acute proximal deep vein thrombosis (DVT) of the lower extremities, with or without contemporary manifestations of pulmonary embolism, are randomized to receive either a fixed duration of anticoagulant therapy (three months in patients with DVT secondary to transitory risk factors, six months in patients with idiopathic DVT) or a flexible duration of anticoagulant therapy, according to the persistence of residual thrombi, as shown by leg veins ultrasonography (up to 1 year in patients with secondary DVT, up to 2 years in those with idiopathic DVT). All patients are followed up to three years to assess the development of (objectively documented) recurrent thromboembolism. The rate of recurrent thromboembolism is compared between the two study groups, as well as the rate of major bleeding complications occurring during anticoagulation.

Conditions

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• The main efficacy outcome is objectively confirmed recurrent thromboembolism from randomization up to completion of 33 months of follow-up.

  33 months

Secondary Outcomes (1)

• To establish clinical and/or laboratory parameters associated with the development of recurrent thromboembolism

  33 months

Study Arms (2)

1

EXPERIMENTAL

Tailoring the duration of anticoagulation according to the ultrasound persistence of residual vein thrombosis

Drug: sodium warfarin

2

ACTIVE COMPARATOR

Administering a fixed duration of anticoagulation (i.e., discontinue it at the time of randomization in patients with secondary DVT, and prolong it for 3 additional months in patients with idiopathic DVT)

Drug: sodium warfarin

Interventions

Sodium warfarin DRUG

dosage: as much as it is required to prolong the international normalized ratio, checked every 2-3 weeks, between 2.0 and 3.0

1; 2

Eligibility Criteria

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

You may qualify if:

• acute proximal DVT associated or not with clinically symptomatic pulmonary embolism

You may not qualify if:

• history of previous VTE
• active cancer
• indications for permanent anticoagulation
• contraindications to anticoagulation
• pregnancy
• geographical inaccessibility for long-term follow-up
• life expectancy shorter than 1 year
• refusal of informed consensus

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua

Padua, Padua, 35128, Italy

Location

Related Publications (1)

• Prandoni P, Prins MH, Lensing AW, Ghirarduzzi A, Ageno W, Imberti D, Scannapieco G, Ambrosio GB, Pesavento R, Cuppini S, Quintavalla R, Agnelli G; AESOPUS Investigators. Residual thrombosis on ultrasonography to guide the duration of anticoagulation in patients with deep venous thrombosis: a randomized trial. Ann Intern Med. 2009 May 5;150(9):577-85. doi: 10.7326/0003-4819-150-9-200905050-00003.

  PMID: 19414836 DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Vitamin B 6

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paolo Prandoni, MD, PhD

  Department of Medical and Surgical Sciences, University of Padua, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 22, 2006
• First Posted: September 25, 2006
• Study Start: January 1, 1999
• Primary Completion: June 1, 2003
• Study Completion: June 1, 2006
• Last Updated: March 18, 2008

Record last verified: 2008-03

Locations

IT (1)