D-dimer to Establish Duration of Anticoagulation After Venous Thromboembolism

NCT00264277 | Completed Phase 4

• 1 other identifier: PROLONG STUDY
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain. The present study addresses the possible role of the D-dimer test in assessing the need for continuation of anticoagulation.The study aims at assessing whether D-dimer assay may have a role in guiding the duration of anticoagulation in these patients

Conditions

Deep Vein Thrombosis; Pulmonary Embolism

Keywords

D-dimer; Recurrence; Venous Thromboembolism; Anticoagulation; Duration

Outcome Measures

Primary Outcomes (2)

• Confirmed recurrent proximal deep vein thrombosis and/or pulmonary embolism at 18 months follow up

• Confirmed major bleeding events at 18 months follow up

Interventions

Vitamin K antagonist (Coumarin anticoagulants) DRUG

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• After a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism
• After at least 3 months of oral anticoagulation
• After written informed consent

You may not qualify if:

• If the Venous thromboembolism occurred:
• during pregnancy or puerperium
• after recent (i.e. within three months) fracture or plaster casting of a leg,
• after immobilization with confinement to bed for three consecutive days
• after surgery with general anesthesia lasting longer than 30 minutes
• Patients with:
• active cancer
• antiphospholipid antibody syndrome
• antithrombin deficiency
• serious liver disease or renal insufficiency (creatininemia \> 2 mg/dL),
• other indications for anticoagulation or contraindications for this treatment
• limited life expectation
• Patients who live too far from the clinical center

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Dept. of Angiology & Blood Coagulation, University Hospital S. Orsola-Malpighi

Bologna, BO, 40138, Italy

Location

Related Publications (7)

• 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

• Palareti G, Legnani C, Cosmi B, Valdre L, Lunghi B, Bernardi F, Coccheri S. Predictive value of D-dimer test for recurrent venous thromboembolism after anticoagulation withdrawal in subjects with a previous idiopathic event and in carriers of congenital thrombophilia. Circulation. 2003 Jul 22;108(3):313-8. doi: 10.1161/01.CIR.0000079162.69615.0F. Epub 2003 Jul 7.

  PMID: 12847064 BACKGROUND

• Eichinger S, Minar E, Bialonczyk C, Hirschl M, Quehenberger P, Schneider B, Weltermann A, Wagner O, Kyrle PA. D-dimer levels and risk of recurrent venous thromboembolism. JAMA. 2003 Aug 27;290(8):1071-4. doi: 10.1001/jama.290.8.1071.

  PMID: 12941680 BACKGROUND

• 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 RESULT

• Cosmi B, Legnani C, Pengo V, Ghirarduzzi A, Testa S, Poli D, Prisco D, Tripodi A, Palareti G; PROLONG Investigators (on behalf of FCSA, Italian Federation of Anticoagulation Clinics). The influence of factor V Leiden and G20210A prothrombin mutation on the presence of residual vein obstruction after idiopathic deep-vein thrombosis of the lower limbs. Thromb Haemost. 2013 Mar;109(3):510-6. doi: 10.1160/TH12-01-0041. Epub 2013 Jan 10.

  PMID: 23306310 DERIVED

• Cosmi B, Legnani C, Tosetto A, Pengo V, Ghirarduzzi A, Testa S, Prisco D, Poli D, Tripodi A, Palareti G; Prolong Investigators. Sex, age and normal post-anticoagulation D-dimer as risk factors for recurrence after idiopathic venous thromboembolism in the Prolong study extension. J Thromb Haemost. 2010 Sep;8(9):1933-42. doi: 10.1111/j.1538-7836.2010.03955.x.

  PMID: 20553388 DERIVED

• Cosmi B, Legnani C, Tosetto A, Pengo V, Ghirarduzzi A, Testa S, Prisco D, Poli D, Tripodi A, Palareti G; PROLONG Investigators; FCSA, Italian Federation of Anticoagulation Clinics. Comorbidities, alone and in combination with D-dimer, as risk factors for recurrence after a first episode of unprovoked venous thromboembolism in the extended follow-up of the PROLONG study. Thromb Haemost. 2010 Jun;103(6):1152-60. doi: 10.1160/TH09-11-0759. Epub 2010 Mar 29.

  PMID: 20352167 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Recurrence; Venous Thromboembolism

Condition Hierarchy (Ancestors)

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

Study Officials

• GUALTIERO PALARETI, MD

  Head of Dept. Angiology & Blood Coagulation, University Hospital S. Orsola-Malpighi, Bologna, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2005
• First Posted: December 12, 2005
• Study Start: September 1, 2002
• Primary Completion: December 1, 2004
• Study Completion: September 1, 2005
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

IT (1)