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

NCT00428441 | Terminated Results

• 1 other identifier: 2175
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Keywords

D-dimer; Recurrence; Venous thromboembolism

Outcome Measures

Primary Outcomes (2)

• Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels

  Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis

  1 year

• Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations

  3 months

Secondary Outcomes (3)

• Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy

  3 months

• Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy

  3 months

• Mortality

  3 months

Interventions

Warfarin DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

University Of Insubria

Varese, 21100, Italy

Location

Related Publications (2)

• 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.

  PMID: 17065639 BACKGROUND

• 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.

  PMID: 11848459 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism; Recurrence

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Walter Ageno
• Organization: University of Insubria

agewal@yahoo.com

+39 0332 278831

Study Officials

• Gualtiero Palareti

  University of Bologna

  STUDY CHAIR

• Walter Ageno

  Università degli Studi dell'Insubria

  STUDY DIRECTOR

• Vittorio Pengo

  University of Padova

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: January 26, 2007
• First Posted: January 30, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: May 1, 2011
• Last Updated: September 26, 2011
• Results First Posted: September 26, 2011

Record last verified: 2011-08

Locations

IT (1)