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REduced Dose Versus Full-dose of Direct Oral Anticoagulant After uNprOvoked Venous thromboEmbolism. (RENOVE)

Primary Purpose

Venous Thromboembolism

Status
Active
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Reduced dose of DOAC
Full dose of DOAC
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Venous Thromboembolism, Anticoagulant, Direct oral anticoagulant, risk of recurrent venous thromboembolism, anticoagulant-related bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (-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 Criteria:

  • 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

Sites / Locations

  • CHU Amiens-Picardie
  • CHU Angers
  • CH d'Arras
  • CHU de Besançon - Hôpital Jean Minjoz
  • CH Bordeaux
  • HIA Brest
  • CHRU de Brest
  • Clinique de Clapiers
  • HIA Percy
  • Cabinet médical
  • CHU de Clermont Ferrand - Hôpital Gabriel Montpied
  • APHP Hôpital Louis Mourier
  • CHU de Dijon
  • CHU de Grenoble - Hôpital Nord Michallon
  • GH Le Havre
  • CH Le Mans
  • CHU de Limoges - Hôpital de Dupuytren
  • CH Morlaix
  • Chru Nancy
  • CHU de Nantes
  • CHU de Nice - Hôpital Pasteur
  • CHU Nîmes
  • CHR Orléans
  • Hôpital de Cochin
  • HEGP
  • CHU Paris Nord Val de Seine
  • HEGP
  • Kremlin Bicêtre
  • CH de Périgueux
  • CH de Quimper
  • CHU de Rennes - Hôpital Sud
  • CHU de ROUEN
  • CH de Saint Brieuc - Hôpital Yves Le Foll
  • CHU de Saint Etienne - Hôpital Nord
  • CH de Toulon - Hôpital Sainte-Musse
  • HIA Sainte-Anne
  • CHU de Toulouse - Hôpital de Rangueil
  • CHU de Tours - Hôpital Trousseau
  • CH Valenciennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reduced dose of DOAC

Full dose of DOAC

Arm Description

A reduced dose of DOAC (apixaban 2.5 mg twice daily or rivaroxaban 10 mg once daily) during a mean follow-up period of 36 months (12 to 65 months)

A full dose of DOAC (Apixaban 5 mg twice daily or Rivaroxaban 20 mg once daily) during a mean follow-up period of 36 months (12 to 65 months).

Outcomes

Primary Outcome Measures

Recurrent VTE
Adjudicated symptomatic objectively confirmed recurrent VTE (non fatal or fatal VTE) during the study treatment period.

Secondary Outcome Measures

Major and clinically relevant non major bleeding
Adjudicated major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis) or clinically relevant non major bleeding during the study treatment period
The composite of recurrent VTE or major bleeding or non major clinically relevant bleeding
The composite of adjudicated recurrent VTE or major bleeding or non major clinically relevant bleeding during the study treatment period will be adjudicated
Mortality
Mortality of other cause than recurrent VTE or major or clinically relevant non major bleeding during the study treatment period will be adjudicated
Compliance
Treatment compliance will be evaluated
Treatment effect
The heterogeneity of the treatment effect on predefined strata will be evaluated
Arterial cardio-vascular events
The arterial cardio-vascular events (myocardial infarction, stroke, cardio-vascular complication other than VTE) will be evaluated

Full Information

First Posted
September 14, 2017
Last Updated
September 11, 2023
Sponsor
University Hospital, Brest
Collaborators
University Hospital of Saint-Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT03285438
Brief Title
REduced Dose Versus Full-dose of Direct Oral Anticoagulant After uNprOvoked Venous thromboEmbolism.
Acronym
RENOVE
Official Title
REduced Dose Versus Full-dose of Direct Oral Anticoagulant After uNprOvoked Venous thromboEmbolism. The RENOVE Open-label, Randomized, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2, 2017 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
University Hospital of Saint-Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 guidelines recommend indefinite anticoagulation. However, prolonged use of warfarin or DOAC at therapeutic dose is associated with a significant risk of bleeding. Consequently, it has been hypothesized that extended anticoagulation at lower dosage might be as effective as and safer than full dose of anticoagulation. However, low-dose warfarin (INR 1.5-2) was less effective and not safer than conventional dose warfarin (INR 2-3). Low dose of DOAC has the potential to validate this hypothesis. In a first randomized trial comparing full-dose or low-dose apixaban with a placebo during an additional one year of anticoagulation in patients where physicians were uncertain for prolonging anticoagulation ("Amplify-extension trial"), low-dose apixaban was more effective than placebo without any major concern regarding safety and possibly as effective as and safer than full-dose apixaban; in a second randomized trial comparing full-dose or low-dose rivaroxaban with aspirin, during an additional one year of anticoagulation in patients where physicians were uncertain for prolonging anticoagulation ("Einstein-Choice trial"), low-dose rivaroxaban was more effective than aspirin without any major concern regarding safety and possibly as effective as and safer than full-dose rivaroxaban. However, these two studies were not designed and powered to demonstrate non-inferiority on efficacy and superiority on safety of a reduced dose of DOAC versus a full dose DOAC and the selected population did not have strong indications for indefinite anticoagulation. Thus, there is currently no evidence to recommend a reduced dose rather than a full dose of DOAC for extended therapy in patients at high risk of recurrent VTE. Consequently, a randomized trial comparing low-dose DOAC with full-dose DOAC therapy in patients at high risk of recurrent VTE is needed and justified. Main hypothesis: After VTE at high risk of recurrence initially treated during 6 (-15 days) to 24 (+ 3 months) uninterrupted months, a reduced dose of DOAC will be non-inferior to a full dose of DOAC in terms of recurrent VTE during extended anticoagulation phase.
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 additional 18 months of warfarin (target international normalized ratio (INR) from 2 to 3) versus placebo in 371 patients who have completed 6 months of anticoagulation for a first unprovoked pulmonary embolism, the PADIS-PE trial confirmed that prolonged warfarin therapy was highly effective for preventing recurrent VTE but that benefit was lost after stopping anticoagulation. In another trial, similar findings had been reported using direct oral anticoagulants (DOAC) at therapeutic dose. These results reinforce international recommendation for indefinite anticoagulation in patients at high risk of recurrent VTE (unprovoked VTE, recurrent VTE or persistent risk factors). However, prolonged use of warfarin or DOAC at therapeutic dose is associated with a significant risk of bleeding. Consequently, it has been hypothesized that extended anticoagulation at lower dosage might be as effective as and safer than full dose of anticoagulation. However, low-dose warfarin (INR 1.5-2) was less effective and not safer than conventional dose warfarin (INR 2-3). Low dose of DOAC has the potential to validate this hypothesis. First, DOACs have been shown to be as effective as and safer than warfarin (INR 2-3) during the first 6 months of anticoagulation after an acute VTE. Second, in a first randomized trial comparing full-dose or low-dose apixaban with a placebo during an additional one year of anticoagulation in patients where physicians were uncertain for prolonging anticoagulation ("Amplify-extension trial"), low-dose apixaban was more effective than placebo without any major concern regarding safety and possibly as effective as and safer than full-dose apixaban; in a second randomized trial comparing full-dose or low-dose rivaroxaban with aspirin, during an additional one year of anticoagulation in patients where physicians were uncertain for prolonging anticoagulation ("Einstein-Choice trial"), low-dose rivaroxaban was more effective than aspirin without any major concern regarding safety and possibly as effective as and safer than full-dose rivaroxaban. However, these two studies were not designed and powered to demonstrate non-inferiority on efficacy and superiority on safety of a reduced dose of DOAC versus a full dose DOAC and the selected population did not have strong indications for indefinite anticoagulation. Thus, there is currently no evidence to recommend a reduced dose rather than a full dose of DOAC for extended therapy in patients at high risk of recurrent VTE. Consequently, a randomized trial comparing low-dose DOAC with full-dose DOAC therapy in patients at high risk of recurrent VTE is needed and justified. Main hypothesis: After VTE at high risk of recurrence initially treated during 6 (-15 days) to 24 (+3 months) uninterrupted months, a reduced dose of DOAC will be non-inferior to a full dose of DOAC in terms of recurrent VTE during extended anticoagulation phase. Design The "RENOVE" trial is designed as an academic, multicenter, open, with blind evaluation (PROBE), randomized, parallel arm, controlled, trial sponsored by the Brest University Hospital Center. Patients meeting the inclusion criteria will be randomized at visit 1 (day 0) and allocated to receive: either a reduced dose of DOAC (apixaban 2.5 mg twice daily or rivaroaxaban 10 mg once daily) during a mean follow-up period of 36 months. or a full dose of DOAC (Apixaban 5 mg twice daily or Rivaroxaban 20 mg once daily) during a mean follow-up period of 36 months. The study is powered to demonstrate the following hypotheses using a three steps hierarchical analysis: Primary hypothesis: non-inferiority of a reduced dose of DOAC as compared to a full dose of DOAC on the risk of recurrent VTE; Secondary hypothesis: in case of the confirmation of the previous hypothesis, superiority of a reduced dose of DOAC on the risk of major or clinically relevant non-major bleeding. Third hypothesis: in case of the confirmation of the previous hypothesis, superiority of a reduced dose of DOAC on the risk of the composite of recurrent VTE, major bleeding or clinically relevant non major bleeding. Randomization will be centralized and stratified on: Center Type of DOAC antiplatelet agent taking At visit 1, patients will have a therapeutic education and they will be instructed to call research team in case of any medical event during the study treatment period. Follow-up visits will be planned at 3, 6, 12 months and every 6 months until study end (i.e.; after the last included patient has achieved 12-month of study treatment period). All critical events will be adjudicated by an independent adjudication committee blinded from the treatment allocation. A data safety board will be constituted and will meet on a regular basis. Duration of each patient's participation will be on average 36 months (12 months for the last included patient) and a total duration of the study is expected for 65 months. Objectives: Main Objective • To demonstrate that a reduced dose of DOAC is non-inferior to a full dose of DOAC for the risk of recurrent VTE during the during a mean study treatment period of 36 months in patients with VTE that warrants indefinite anticoagulation and who have been initially treated for 6 (-15 days) to 24 (+3 months) uninterrupted months. Secondary Objectives • Key secondary objectives: if the main objective is verified, key secondary objectives are to demonstrate the superiority of a reduced dose of DOAC over a full dose of DOAC during a mean study treatment period of 36 months : on the risk of major or CRNMB and, if confirmed, on the composite of recurrent VTE, major bleeding or CRNMB. • Other secondary objectives: To evaluate the benefit of a reduced dose of DOAC on the risk of major bleeding during a mean study treatment period of 36 months To evaluate the benefit of a reduced dose of DOAC on the composite outcome of recurrent VTE and major bleeding during a mean study treatment period of 36 months To determine the impact of a reduced dose of DOAC on deaths of all causes and deaths related to recurrent VTE or major bleeding during a mean study treatment period of 36 months To evaluate dyspnea and post-thrombotic syndrome (villalta score)(65). To evaluate compliance treatment using the Morisky auto-questionnaire (66,67) To analyse the treatment effect on recurrent VTE and major bleeding and CRNM among predefined sub-groups (screening for heterogeneity among predefined strata). Sample size justification A- Initial hypothesis before starting enrolment in the RENOVE study: The study is powered to demonstrate the following hypotheses using a three steps hierarchical analysis: Primary hypothesis: non-inferiority of a reduced dose of DOAC as compared to a full dose of DOAC on the risk of recurrent VTE. Based on an expected rate of recurrent VTE of 2%/year (4% during the entire study period) in each group and a requirement that the study would have 90% power to exclude a hazard ratio of 1.7 for the primary outcome with a reduced dose of DOAC, at a two-sided alpha level of 0.05, 1030 patients need to be included in each treatment group. Secondary hypothesis: in case of the confirmation of the previous hypothesis, superiority of a reduced dose of DOAC on the risk of major or clinically relevant non-major bleeding. Assuming an estimated incidence in the warfarin group of 10% in the entire study period and a reduction in the relative risk of at least 35% with a reduced dose of DOAC as compared with a full dose of DOAC, 966 patients in each group for the study to have 80% power to show the superiority of a reduced dose of DOAC over a full dose of DOAC, at a two-sided alpha level of 0.05. Third hypothesis: in case of the confirmation of the previous hypothesis, superiority of a reduced dose of DOAC on the risk of the composite of recurrent VTE, major bleeding or clinically relevant non major bleeding. Assuming an estimated incidence in the full dose DOAC group of 14% and 10% in the a reduced dose of DOAC group in the entire study period, 1029 patients in each group for the study to have 80% power to show the superiority of a reduced dose of DOAC over a full dose of DOAC, at a two-sided alpha level of 0.05. Taking in account 5% of loss to follow-up, a total of 2200 patients are required in order to be able to confirm these three conditional hypotheses. All estimates were calculated based on major randomized trials on extended anticoagulation in VTE patients. B- New hypothesis based on observed primary endpoint at 2147 included patients: On February, 12th 2021, 27 recurrent VTE, all adjudicated, occurred on 2147 included patients, during a mean follow-up of 12 months. From 0 to 12 months, there were 15 recurrent VTE in 2147 patients during this period (0.7%); and from 12 to 24 months, there were 12 recurrent VTE in 1551 patients during this period (0.8%). The incidence of recurrence seems to be linear, with 0.75% patients with recurrent VTE during a mean follow-up of 12 months. Consequently, the expected proportion of recurrent VTE during 24 months will be 1.5% and not 4% as previously expected before study started. The scientific committee, blinded of treatment group, decided to increase both the number of sample size and the follow-up with a new "first" hypothesis on recurrent VTE: New First hypothesis: same non inferiority of a reduced dose of DOAC compared to a full dose of DOAC on the risk of recurrent VTE. Based on a new expected rate of recurrent VTE of 3% in each group during the entire study period for the same power (90%) and the same alpha level (two-side alpha level of 0.05), with a similar hazard ratio non-inferiority margin, i.e., 1.7, 1387 patients need to be included in each treatment group. Thus, a total of 2774 patients need to be recruited, which correspond to 574 patients in addition to 2200. Keeping in mind that the recruitment is 60 patients per months, the time to recruit 574 additional patients will take 6 months. We will stop the study after the last included patient has been followed at least 12 months. Thus, the study is prolonged by 18 additional months (6 to 8 months recruitment + 12-month follow up of the last patient).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
Venous Thromboembolism, Anticoagulant, Direct oral anticoagulant, risk of recurrent venous thromboembolism, anticoagulant-related bleeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The trial is designed as an academic, multicenter, open, with blind evaluation (PROBE), randomized, parallel arm, controlled.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2774 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reduced dose of DOAC
Arm Type
Experimental
Arm Description
A reduced dose of DOAC (apixaban 2.5 mg twice daily or rivaroxaban 10 mg once daily) during a mean follow-up period of 36 months (12 to 65 months)
Arm Title
Full dose of DOAC
Arm Type
Active Comparator
Arm Description
A full dose of DOAC (Apixaban 5 mg twice daily or Rivaroxaban 20 mg once daily) during a mean follow-up period of 36 months (12 to 65 months).
Intervention Type
Drug
Intervention Name(s)
Reduced dose of DOAC
Intervention Description
The patient will receive apixaban 2.5 mg twice daily or rivaroxaban 10 mg once daily during a mean follow-up period of 36 months (12 to 65 months)
Intervention Type
Drug
Intervention Name(s)
Full dose of DOAC
Intervention Description
The patient will receive apixaban 5 mg twice daily or Rivaroxaban 20 mg once daily during a mean follow-up period of 36 months (12 to 65 months)
Primary Outcome Measure Information:
Title
Recurrent VTE
Description
Adjudicated symptomatic objectively confirmed recurrent VTE (non fatal or fatal VTE) during the study treatment period.
Time Frame
during a mean study treatment period of 36 months
Secondary Outcome Measure Information:
Title
Major and clinically relevant non major bleeding
Description
Adjudicated major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis) or clinically relevant non major bleeding during the study treatment period
Time Frame
during a mean study treatment period of 36 months
Title
The composite of recurrent VTE or major bleeding or non major clinically relevant bleeding
Description
The composite of adjudicated recurrent VTE or major bleeding or non major clinically relevant bleeding during the study treatment period will be adjudicated
Time Frame
during a mean study treatment period of 36 months
Title
Mortality
Description
Mortality of other cause than recurrent VTE or major or clinically relevant non major bleeding during the study treatment period will be adjudicated
Time Frame
during a mean study treatment period of 36 months
Title
Compliance
Description
Treatment compliance will be evaluated
Time Frame
during a mean study treatment period of 36 months
Title
Treatment effect
Description
The heterogeneity of the treatment effect on predefined strata will be evaluated
Time Frame
during a mean study treatment period of 36 months
Title
Arterial cardio-vascular events
Description
The arterial cardio-vascular events (myocardial infarction, stroke, cardio-vascular complication other than VTE) will be evaluated
Time Frame
during a mean study treatment period of 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 (-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 Criteria: 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
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Angers
City
Angers
Country
France
Facility Name
CH d'Arras
City
Arras
ZIP/Postal Code
62022
Country
France
Facility Name
CHU de Besançon - Hôpital Jean Minjoz
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
CH Bordeaux
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
HIA Brest
City
Brest
ZIP/Postal Code
29240
Country
France
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Clinique de Clapiers
City
Castelnau le Lez
ZIP/Postal Code
34170
Country
France
Facility Name
HIA Percy
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
Cabinet médical
City
Clapiers
ZIP/Postal Code
34830
Country
France
Facility Name
CHU de Clermont Ferrand - Hôpital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
APHP Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU de Grenoble - Hôpital Nord Michallon
City
Grenoble
ZIP/Postal Code
38700
Country
France
Facility Name
GH Le Havre
City
Le Havre
ZIP/Postal Code
76290
Country
France
Facility Name
CH Le Mans
City
Le Mans
ZIP/Postal Code
72 000
Country
France
Facility Name
CHU de Limoges - Hôpital de Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CH Morlaix
City
Morlaix
ZIP/Postal Code
29 672
Country
France
Facility Name
Chru Nancy
City
Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
CHU de Nice - Hôpital Pasteur
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
CHU Nîmes
City
Nîmes
ZIP/Postal Code
30 029
Country
France
Facility Name
CHR Orléans
City
Orléans
ZIP/Postal Code
45100
Country
France
Facility Name
Hôpital de Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
HEGP
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CHU Paris Nord Val de Seine
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
HEGP
City
Paris
Country
France
Facility Name
Kremlin Bicêtre
City
Paris
Country
France
Facility Name
CH de Périgueux
City
Périgueux
ZIP/Postal Code
24019
Country
France
Facility Name
CH de Quimper
City
Quimper
ZIP/Postal Code
29107
Country
France
Facility Name
CHU de Rennes - Hôpital Sud
City
Rennes
ZIP/Postal Code
35203
Country
France
Facility Name
CHU de ROUEN
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
CH de Saint Brieuc - Hôpital Yves Le Foll
City
Saint-Brieuc
ZIP/Postal Code
22000
Country
France
Facility Name
CHU de Saint Etienne - Hôpital Nord
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Facility Name
CH de Toulon - Hôpital Sainte-Musse
City
Toulon
ZIP/Postal Code
83056
Country
France
Facility Name
HIA Sainte-Anne
City
Toulon
ZIP/Postal Code
83800
Country
France
Facility Name
CHU de Toulouse - Hôpital de Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU de Tours - Hôpital Trousseau
City
Tours
ZIP/Postal Code
37170
Country
France
Facility Name
CH Valenciennes
City
Valenciennes
ZIP/Postal Code
59 322
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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REduced Dose Versus Full-dose of Direct Oral Anticoagulant After uNprOvoked Venous thromboEmbolism.

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