PROLONG Study
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Official Title
D-Dimer Test to Establish Duration of Anticoagulation After a First Idiopathic Episode of Venous Thromboembolism; the Prospective Randomized “Prolong” Study
Objective
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.
Sponsor
St. Orsola Hospital
Timeline
| Timeline | |
| Start Date | September 2002 |
| End Date | Not provided |
| Status | Completed |
The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00264277.
Study Description
| Study Description | |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | |
| Allocation | Randomised |
| Endpoint | Safety/Efficacy Study |
| Interventional Model | Parallel Assignment |
| Masking | Open Label |
| Study Details | |
| Primary Purpose | Treatment |
| Condition | Deep Vein Thrombosis Pulmonary Embolism |
| Intervention | Vitamin K antagonist (Coumarin anticoagulants) |
| Study Arms | Not provided |
| Population Size | 600 |
The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT-----.
Eligibility 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
Outcomes
Primary Outcomes
- Confirmed recurrent proximal deep vein thrombosis and/or pulmonary embolism at 18 months follow up
- Confirmed major bleeding events at 18 months follow up
Secondary Outcomes
Not provided