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NCT Number: NCT00264277

D-dimer to Establish Duration of Anticoagulation After Venous Thromboembolism

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

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Disease Attributes Embolism Embolism and Thrombosis Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Recurrence Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Bologna, BO, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin K antagonist (Coumarin anticoagulants)

Drug

Primary outcomes

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

  2. Confirmed major bleeding events at 18 months follow up

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

D-dimer Test to Establish Duration of Anticoagulation After a First Idiopathic Episode of Venous Thromboembolism; the Prospective Randomized "Prolong" Study

Important dates

Study start
2002
Primary completion
2004
Study completion
2005
First posted
Dec 12, 2005
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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