- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00264277
D-dimer to Establish Duration of Anticoagulation After Venous Thromboembolism
March 18, 2021 updated by: GUALTIERO PALARETI, IRCCS Azienda Ospedaliero-Universitaria di Bologna
D-dimer Test to Establish Duration of Anticoagulation After a First Idiopathic Episode of Venous Thromboembolism; the Prospective Randomized "Prolong" Study
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment
600
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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BO
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Bologna, BO, Italy, 40138
- Dept. of Angiology & Blood Coagulation, University Hospital S. Orsola-Malpighi
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Confirmed recurrent proximal deep vein thrombosis and/or pulmonary embolism at 18 months follow up
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Confirmed major bleeding events at 18 months follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: GUALTIERO PALARETI, MD, Head of Dept. Angiology & Blood Coagulation, University Hospital S. Orsola-Malpighi, Bologna, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1161/01.CIR.0000079162.69615.0F. 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. doi: 10.1001/jama.290.8.1071.
- 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. Erratum In: N Engl J Med. 2006 Dec 28;355(26):2797.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Primary Completion (ACTUAL)
December 1, 2004
Study Completion (ACTUAL)
September 1, 2005
Study Registration Dates
First Submitted
December 9, 2005
First Submitted That Met QC Criteria
December 9, 2005
First Posted (ESTIMATE)
December 12, 2005
Study Record Updates
Last Update Posted (ACTUAL)
March 19, 2021
Last Update Submitted That Met QC Criteria
March 18, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Embolism and Thrombosis
- Embolism
- Thrombosis
- Venous Thrombosis
- Thromboembolism
- Venous Thromboembolism
- Pulmonary Embolism
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Micronutrients
- Vitamins
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Vitamin K
- Anticoagulants
Other Study ID Numbers
- PROLONG STUDY
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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