D-Dimer to Establish Duration of Anticoagulation After Venous Thromboembolism - Full Text View

Purpose

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

Condition	Intervention	Phase
Deep Vein Thrombosis Pulmonary Embolism	Drug: Vitamin K antagonist (Coumarin anticoagulants)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	D-Dimer Test to Establish Duration of Anticoagulation After a First Idiopathic Episode of Venous Thromboembolism; the Prospective Randomized “Prolong” Study

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis Pulmonary Embolism Vitamin K

Drug Information available for: Menadione

U.S. FDA Resources

Further study details as provided by St. Orsola Hospital:

Primary Outcome Measures:

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

Estimated Enrollment:	600
Study Start Date:	September 2002
Estimated Study Completion Date:	September 2005

Detailed Description:

This is a multicenter prospective follow-up study in patients with a first episode of symptomatic idiopathic venous thromboembolism (proximal deep vein thrombosis and/or pulmonary embolism) who are treated with vitamin K antagonists (either warfarin or acenocoumarol) for a minimum of 3 months. Eligible patients who give informed consent are instructed to immediately stop oral anticoagulation and refrain from taking any other antithrombotic drugs until the next visit, scheduled after 3010 days. At that visit, venous blood is sampled to perform D-dimer assay and thrombophilia tests. D-dimers are assessed using the Clearview Simplify D-dimer assay (Agen Biomedical Limited, Brisbane, Australia). Patients with normal D-dimer results do not continue anticoagulation, whereas those with elevated D-dimer results are randomized using a computer program to either stop or resume anticoagulation with vitamin K antagonists (INR 2.0-3.0). All patients are followed-up for 18 months. The study outcome are the composite of confirmed recurrent venous thromboembolism and major bleeding events. All suspected outcome events and all deaths are evaluated by a central adjudication committee whose members are unaware of the D-dimer and thrombophilia results and of the group assignments.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264277

Locations

Italy
Dept. of Angiology & Blood Coagulation, University Hospital S. Orsola-Malpighi
Bologna, BO, Italy, 40138

Sponsors and Collaborators

St. Orsola Hospital

Investigators

Study Chair:

GUALTIERO PALARETI, MD

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

More Information

Publications:

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.

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.

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. Epub 2003 Jul 7.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 5;109(3):510-6. doi: 10.1160/TH12-01-0041. Epub 2013 Jan 10.

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.

Cosmi B, Legnani C, Tosetto A, Pengo V, Ghirarduzzi A, Testa S, Prisco D, Poli D, Tripodi A, Palareti G; PROLONG Investigators. 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 1;103(6):1152-60. Epub 2010 Mar 29.

ClinicalTrials.gov Identifier:	NCT00264277 History of Changes
Other Study ID Numbers:	PROLONG STUDY
Study First Received:	December 9, 2005
Last Updated:	December 1, 2006
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by St. Orsola Hospital:

D-dimer
Recurrence
Venous Thromboembolism
Anticoagulation
Duration

Additional relevant MeSH terms:

Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Coumarin
Anticoagulants
Coumarins

Vitamin K
Vitamins
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on May 19, 2013