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Echo Doppler (ED )Score and D-dimer (DD) Level in the Evaluation of VTE Recurrence After Anticoagulant Treatment Cessation (VAPRED)

Primary Purpose

Previous Vka Treatment, Previous Proximal VTE

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
ED, DDimers and phone follow up
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Previous Vka Treatment focused on measuring VTE, VKA treatment, VKA treatment cessation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • > 18 and <80 years old
  • First or second treated proximal VTE event (+/- Pulmonary embolism)
  • Signed informed consent

Exclusion Criteria:

  • Active cancer or currently treated
  • Previous VTE>2
  • Long term anticoagulant treatment for VTE diseases
  • Long term anticoagulant treatment for other diseases
  • Pregnancy, parturient or breast feeding
  • Person deprived of freedom by judicial or administrative decision
  • Consent unsigned

Sites / Locations

  • University Hospital
  • Cabinet Medical
  • HOSPITAL
  • Cabinet Medical
  • Cabinet Medical
  • HOSPITAL
  • Cabinet Medical
  • Cabinet Medical
  • Vascular Medecine Departement - University Hospital of Grenoble
  • Cabinet Medical
  • Clinique Mutualiste les eaux claires
  • Cabinet Medical
  • Cabinet Medical
  • Cabinet Medical
  • CMC Les Petites Roches
  • Cabinet Medical

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Follow up

Arm Description

ED score and DDimer level of patients who have stopped their VKA treatment (after the first or the second previous proximal VTE). Phone follow up for 2 years.

Outcomes

Primary Outcome Measures

VTE event recurrence

Secondary Outcome Measures

Full Information

First Posted
March 10, 2009
Last Updated
October 10, 2011
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT00860106
Brief Title
Echo Doppler (ED )Score and D-dimer (DD) Level in the Evaluation of VTE Recurrence After Anticoagulant Treatment Cessation
Acronym
VAPRED
Official Title
Study of Predictive Echo Doppler Score and D-dimer Level in Evaluation of the Thromboembolic Event Recurrence After Anticoagulant Treatment Cessation.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to perform a prospective multicentric study to determine predictive ED score and D-dimer level in the evaluation of the thromboembolic event recurrence after anticoagulant treatment cessation. The patients are included in the study from the anticoagulant treatment cessation. An ED score and a blood sample are performed at this time and one month later. Then, the patients are followed up by phone for 2 years.
Detailed Description
DDimer levels are centralized in University Hospital of Grenoble at the end of the study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Previous Vka Treatment, Previous Proximal VTE
Keywords
VTE, VKA treatment, VKA treatment cessation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Follow up
Arm Type
Other
Arm Description
ED score and DDimer level of patients who have stopped their VKA treatment (after the first or the second previous proximal VTE). Phone follow up for 2 years.
Intervention Type
Other
Intervention Name(s)
ED, DDimers and phone follow up
Intervention Description
ED score, DDimers level and phone questionnary
Primary Outcome Measure Information:
Title
VTE event recurrence
Time Frame
0-2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 18 and <80 years old First or second treated proximal VTE event (+/- Pulmonary embolism) Signed informed consent Exclusion Criteria: Active cancer or currently treated Previous VTE>2 Long term anticoagulant treatment for VTE diseases Long term anticoagulant treatment for other diseases Pregnancy, parturient or breast feeding Person deprived of freedom by judicial or administrative decision Consent unsigned
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles PERNOD, Professor
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Amiens
Country
France
Facility Name
Cabinet Medical
City
Annecy
Country
France
Facility Name
HOSPITAL
City
Annecy
Country
France
Facility Name
Cabinet Medical
City
Bourgoin Jallieu
Country
France
Facility Name
Cabinet Medical
City
Chalon Sur Saone
Country
France
Facility Name
HOSPITAL
City
Chambery
Country
France
Facility Name
Cabinet Medical
City
Crolles
Country
France
Facility Name
Cabinet Medical
City
Fontaine
Country
France
Facility Name
Vascular Medecine Departement - University Hospital of Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Cabinet Medical
City
Grenoble
Country
France
Facility Name
Clinique Mutualiste les eaux claires
City
Grenoble
Country
France
Facility Name
Cabinet Medical
City
Meylan
Country
France
Facility Name
Cabinet Medical
City
Pontcharra
Country
France
Facility Name
Cabinet Medical
City
Saint Egreve
Country
France
Facility Name
CMC Les Petites Roches
City
Saint Hilaire Du Touvet
Country
France
Facility Name
Cabinet Medical
City
Voiron
Country
France

12. IPD Sharing Statement

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Echo Doppler (ED )Score and D-dimer (DD) Level in the Evaluation of VTE Recurrence After Anticoagulant Treatment Cessation

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