REduced dose versus full-dose of direct oral anticoagulant after uNprOvoked Venous thromboEmbolism.

Phase 1

• Conditions: symptomatic PE or proximal DVT) initially treated during 6 to 12 months with anticoagulant therapy; MedDRA version: 20.0Level: PTClassification code 10047249Term: Venous thrombosisSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Patients with indications for long-term anticoagulation after VTE (i.e.

• Registration Number: EUCTR2017-002433-31-FR
• Lead Sponsor: CHRU de BREST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-29
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

- Patients >18 years
- Patients with indications for long-term anticoagulation after VTE (i.e.; symptomatic PE or proximal DVT) initially treated during 6 to 24 months:
•Patients with multiple episodes of VTE, or
•Patients with a first episode of unprovoked VTE
•Patients with VTE associated with persistent risk factor, or
•Patients for whom clinicians feel that indefinite anticoagulation is warranted.
- Social security affiliation.

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 1100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1100

Exclusion Criteria

-Known allergy to rivaroxaban and apixaban
-Unable or refusal to give informed consent
-Isolated DVT
-HERDOO2 score = 1
-Indication for anticoagulation other than DVT or PE (e.g.; atrial fibrillation, mechanic valves…)
-Treatment with investigational drug in the past 1 month
-Interruption of anticoagulation for 14 days or more before the inclusion
-Chronic liver disease or chronic hepatitis
-Patient considered at high risk of bleeding (eg: previous gastro-intestinal tract bleeding in the past three months, uncontrolled hypertension, etc.)
-Creatinine clearance <25 ml/min on Cockcroft and Gault Formula
-Antiphospholipid syndrome
-Dual anti-platelet therapy or aspirin at dosage >100 mg per day
-Concomitant use of a strong inhibitor of cytochrome P-450 3A4 (CYP3A4) (e.g., a protease inhibitor for human immunodeficiency virus infection or azole-antimycotics agents ketoconazole, itraconazole, voriconazole, posaconazole) or a CYP3A4 inducer (e.g., rifampin, carbamazepine, or phenytoin),
-Active cancer of less than 6 months
-Active pregnancy or expected pregnancy
-No effective contraception in women of childbearing age
-Life expectancy <12 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified