A randomized controlled trial of testing and no testing for thrombophilia in patients with a first episode of venous thrombosis or pulmonary embolism (venous thromboembolism, VTE) will be performed. Subsequent additional anticoagulant treatment for a predefined period will be installed in those in whom thrombophilia is detected in the testing group, while others will receive a standard predefined duration of treatment. MedDRA version: 8.1 Level: LLT Classification code 10047249 Term: Venous thr
Conditions
Interventions
Pharmaceutical Form:
INN or Proposed INN: ACENOCOUMAROL
CAS Number: 152727
Other descriptive name: vitamin K antagonist
Concentration unit: mg milligram(s)
Concentration type: range
Concentration num
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects must be willing and able to give written informed consent 2) Confirmed symptomatic DVT, i.e., proximal vein or extensive calf-vein thrombosis, involving at least the upper third part of the deep calf veins (trifurcation, AND/OR confirmed symptomatic PE, no longer than 2 months prior to randomization 3) age 18 years or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Target Disease Exceptions 1. Previous episodes of DVT or PE 2. Active bleeding or high risk for bleeding contraindicating treatment with LMWH, fondaparinux or VKA 3. Insertion of a caval filter to treat the episode of VTE Medical History and Concurrent Diseases 4. Active cancer or anti-cancer treatment in the 6 months prior to the acute episode of VTE 5. Life expectancy < 18 months 6. Arterial thrombotic events in the context of a confirmed antiphospholipid antibody syndrome Prohibited Therapies and/or Medications 7. Indications for VKA other than DVT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary efficacy outcomes are: •recurrent VTE at the end of the study. •a composite endpoint of recurrent VTE and bleeding at the end of the study •quality of life •costs of testing and subsequent predefined prolongation of anticoagulant therapy ;Main Objective: This study aims to assess efficacy and safety of testing for thrombophilia in patients with a first episode of VTE and subsequent additional anticoagulant treatment in those in whom thrombophilia is detected as compared to no testing and standard duration of therapy in all patients. The primary efficacy outcome consists of: •recurrent VTE 18 months after the acute episode of VTE. ;Primary end point(s): The primary efficacy outcome consists of: • recurrent VTE 18 months after the acute episode of VTE. | — |
Countries
Netherlands
Outcome results
None listed