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

This study has been terminated.
(Enrolment was halted prematurely because of the observed excess in recurrences)
ClinicalTrials.gov Identifier:
First Posted: January 30, 2007
Last Update Posted: September 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Walter Ageno, Università degli Studi dell'Insubria

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels [ Time Frame: 1 year ]
    Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis

  • Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy [ Time Frame: 3 months ]
  • Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy [ Time Frame: 3 months ]
  • Mortality [ Time Frame: 3 months ]

Enrollment: 73
Study Start Date: May 2007
Study Completion Date: May 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Warfarin
    tablets, based on INR levels, according to D-dimer levels

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428441

University Of Insubria
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
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

Responsible Party: Walter Ageno, Associate Professor of Internal Medicine, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT00428441     History of Changes
Other Study ID Numbers: 2175
First Submitted: January 26, 2007
First Posted: January 30, 2007
Results First Submitted: August 18, 2011
Results First Posted: September 26, 2011
Last Update Posted: September 26, 2011
Last Verified: August 2011

Keywords provided by Walter Ageno, Università degli Studi dell'Insubria:
Venous thromboembolism

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action