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

January 26, 2007
August 18, 2011
May 2007
June 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • 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
Complete list of historical versions of study NCT00428441 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
D-dimer to Predict Recurrence in Patients With Multiple Episodes of Venous Thromboembolism
The Negative Predictive Value of D-dimer on the Risk of Recurrent Venous Thromboembolism in Patients With Multiple Previous Events: a Prospective Cohort Study

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Thromboembolism
Drug: Warfarin
tablets, based on INR levels, according to D-dimer levels
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
73
May 2011
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00428441
2175
No
Walter Ageno, Università degli Studi dell'Insubria
Università degli Studi dell'Insubria
Not Provided
Study Chair: Gualtiero Palareti University of Bologna
Study Director: Walter Ageno Università degli Studi dell'Insubria
Study Director: Vittorio Pengo University of Padua
Università degli Studi dell'Insubria
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP