D-dimer to Predict Recurrence in Patients With Multiple Episodes of Venous Thromboembolism

NCT ID: NCT00428441

Last Updated: 2011-09-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2011-05-31

Brief Summary

Optimal duration of oral anticoagulant therapy in patients with recurrent episodes of venous thromboembolism (VTE) is a matter of debate and recommendations are based on inadequate evidence. More than 12 months of treatment are currently recommended, and the grade of recommendation is low.

The PROLONG study has recently evaluated the predictive role of D-dimer measurement after withholding oral anticoagulant treatment in patients with a first episode of VTE. Patients with a positive D-dimer had a significantly higher incidence of VTE recurrences than patients with a negative D-dimer and required resumption of the antithrombotic treatment. Based on the results of this and of previous cohort studies, it appears safe to withhold treatment in patients with negative D-dimer values and to continue treatment in patients with altered D-dimer levels.

Aim of this study is therefore to assess the negative predictive value of D-dimer also in patients with recurrent VTE and to evaluate the clinical utility of this approach in this patient setting.

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Warfarin

tablets, based on INR levels, according to D-dimer levels

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with at least two episodes of objectively documented venous thromboembolism (at least one proximal deep vein thrombosis or pulmonary embolism)
• Ongoing treatment with oral anticoagulants for at least a) 12 months in case idiopathic DVT was the last event; b) 6 months in all other cases
• Age > 18 years
• Informed consent provided

Exclusion Criteria

• Pregnancy/puerperium
• One or more episodes of massive pulmonary embolism
• Last event isolated idiopathic pulmonary embolism
• Two or more idiopathic VTE events
• First degree relatives with recurrent VTE
• Right ventricular disfunction or pulmonary hypertension
• Active cancer
• Antiphospholipid antibodies syndrome
• Antithrombin deficiency
• Homozygous Factor V Leiden or G20210A prothrombin mutation
• Heterozygous Factor V Leiden and G20210A prothrombin mutation
• Concomitant congenital thrombophilic mutations
• Concomitant indications to long term oral anticoagulant treatment
• Severe cardiorespiratory insufficiency
• Severe liver or renal disease (creatinine clearance > 2 mg/dL)
• Limited life expectancy
• Geographic inaccessibility

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi dell'Insubria

OTHER

Sponsor Role: lead

Responsible Party

Walter Ageno

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gualtiero Palareti

Role: STUDY_CHAIR

University of Bologna

Walter Ageno

Role: STUDY_DIRECTOR

Università degli Studi dell'Insubria

Vittorio Pengo

Role: STUDY_DIRECTOR

University of Padova

Locations

University Of Insubria

Varese, , Italy

Countries

Italy

References

Palareti G, Cosmi B, Legnani C, Tosetto A, Brusi C, Iorio A, Pengo V, Ghirarduzzi A, Pattacini C, Testa S, Lensing AW, Tripodi A; PROLONG Investigators. D-dimer testing to determine the duration of anticoagulation therapy. N Engl J Med. 2006 Oct 26;355(17):1780-9. doi: 10.1056/NEJMoa054444.

Reference Type: BACKGROUND

PMID: 17065639 (View on PubMed)

Palareti G, Legnani C, Cosmi B, Guazzaloca G, Pancani C, Coccheri S. Risk of venous thromboembolism recurrence: high negative predictive value of D-dimer performed after oral anticoagulation is stopped. Thromb Haemost. 2002 Jan;87(1):7-12.

Reference Type: BACKGROUND

PMID: 11848459 (View on PubMed)

Other Identifiers

2175

Identifier Type: -

Identifier Source: org_study_id