Status:
COMPLETED
REduced Dose Versus Full-dose of Direct Oral Anticoagulant After uNprOvoked Venous thromboEmbolism.
Lead Sponsor:
University Hospital, Brest
Collaborating Sponsors:
University Hospital of Saint-Etienne
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Patients with unprovoked venous thromboembolism (VTE) or VTE associated with persistent risk factors have a high risk of recurrence after stopping anticoagulation. In these patients, international gui...
Detailed Description
Patients with unprovoked venous thromboembolism (VTE) or VTE associated with persistent risk factors have a high risk of recurrence after stopping anticoagulation. In the "PADIS-PE" trial comparing an...
Eligibility Criteria
Inclusion
- Patients \>18 years
- Patients with indications for long-term anticoagulation after VTE (i.e.; symptomatic PE or proximal DVT) initially treated during 6 (-15 days) to 24 months (+ 3 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.
Exclusion
- Known allergy to rivaroxaban and apixaban, allergy to any of the excipients
- Indication for therapeutic dose anticoagulant therapy
- Unable or refusal to give informed consent
- Isolated distal 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 except for patients benefiting from an anticoagulant at therapeutic doses for the initial pathology
- 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.)
- Renal insufficiency with creatinine \<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
Key Trial Info
Start Date :
November 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2023
Estimated Enrollment :
2774 Patients enrolled
Trial Details
Trial ID
NCT03285438
Start Date
November 2 2017
End Date
November 8 2023
Last Update
December 28 2023
Active Locations (39)
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1
CHU Amiens-Picardie
Amiens, France, 80054
2
CHU Angers
Angers, France
3
CH d'Arras
Arras, France, 62022
4
CHU de Besançon - Hôpital Jean Minjoz
Besançon, France, 25000