D-Dimer to Predict Recurrence in Patients With Multiple Episodes of Venous Thromboembolism - Full Text View

Sponsored by:	Università degli Studi dell'Insubria
Information provided by:	Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:	NCT00428441

Purpose

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.

Condition	Intervention
Venous Thromboembolism	Drug: Warfarin

MedlinePlus related topics: Blood Thinners Pulmonary Embolism

Drug Information available for: Warfarin Warfarin potassium Warfarin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Negative Predictive Value of D-Dimer on the Risk of Recurrent Venous Thromboembolism in Patients With Multiple Previous Events: a Prospective Cohort Study

Further study details as provided by Università degli Studi dell'Insubria:

Primary Outcome Measures:

Recurrent deep vein thrombosis or pulmonary embolism in patients with persistently negative D-dimer levels
Rate of patients with altered D-dimer levels and temporal distribution of alterations

Secondary Outcome Measures:

Recurrent deep vein thrombosis or pulmonary embolism in patients who resumed oral anticoagulant therapy
Incidence of major bleeding in patients who resumed oral anticoagulant therapy
Mortality

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428441

Contacts

Contact: Walter Ageno, MD

+39-0332-278594

agewal@yahoo.com

Locations

Italy
University Of Insubria
Varese, Italy, 21100

Sponsors and Collaborators

Università degli Studi dell'Insubria

Investigators

Study Chair:	Gualtiero Palareti	University of Bologna
Study Director:	Walter Ageno	Università degli Studi dell'Insubria
Study Director:	Vittorio Pengo	University of Padua

More Information

Publications:

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.

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.

Study ID Numbers:	2175
Study First Received:	January 26, 2007
Last Updated:	January 29, 2007
ClinicalTrials.gov Identifier:	NCT00428441
Health Authority:	Italy: Ethics Committee

Keywords provided by Università degli Studi dell'Insubria:

D-dimer
Recurrence
Venous thromboembolism

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases
Fibrin fragment D
Warfarin

Venous Thromboembolism
Thrombosis
Recurrence
Thromboembolism

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009