D-dimer to Establish Duration of Anticoagulation After Venous Thromboembolism

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264277
• Other study ID #: PROLONG STUDY
• Status: Completed
• Phase: Phase 4
• Start date: September 2002
• Est. completion date: September 2005

Study information

• Verified date: March 2021
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• Vitamin K antagonist (Coumarin anticoagulants)

Locations

Country	Name	City	State
Italy	Dept. of Angiology & Blood Coagulation, University Hospital S. Orsola-Malpighi	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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 — View Citation

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. — View Citation

Palareti G, Legnani C, Cosmi B, Valdré 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed recurrent proximal deep vein thrombosis and/or pulmonary embolism at 18 months follow up
Primary	Confirmed major bleeding events at 18 months follow up