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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)
Sponsor:
Information provided by (Responsible Party):
Walter Ageno, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT00428441
First received: January 26, 2007
Last updated: August 18, 2011
Last verified: August 2011
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

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
  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

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:

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
Study First Received: January 26, 2007
Results First Received: August 18, 2011
Last Updated: August 18, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Università degli Studi dell'Insubria:
D-dimer
Recurrence
Venous thromboembolism

Additional relevant MeSH terms:
Recurrence
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Disease Attributes
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Warfarin
 Fibrin fragment D
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on May 16, 2013