VAPRED Study
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Official Title
Study of Predictive Echo Doppler Score and D-dimer Level in Evaluation of the Thromboembolic Event Recurrence After Anticoagulant Treatment Cessation
Objective
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
Sponsor
University Hospital, Grenoble
Timeline
| Timeline | |
| Start Date | March 2005 |
| End Date | May 2010 |
| Status | phase 4 |
The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00860106 .
Study Description
| Study Description | |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | |
| Allocation | Non-Randomized |
| Endpoint | Safety Study |
| Interventional Model | Single Group Assignment |
| Masking | Open Label |
| Study Details | |
| Primary Purpose | Prevention |
| Condition | Previous Vka Treatment Previous Proximal VTE |
| Intervention | Echo Doppler (ED), DDimers and phone follow up ED score, DDimers level and phone questionnary |
| Study Arms | Follow up 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: Other: ED, DDimers and phone follow up |
| Population Size | 222 |
The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00860106 .
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
Outcomes
Primary Outcomes
VTE event recurrence [ Time Frame: 0-2 years ] [ Designated as safety issue: Yes ]
Secondary Outcomes
Not provided
Publications
Results
Conclusion
References
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