VAPRED Study: Difference between revisions
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| '''End Date'''||May 2010 | | '''End Date'''||May 2010 | ||
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| '''Status'''|| | | '''Status'''||phase 4 | ||
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<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/ | <span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00860106 .</span> | ||
==Study Description== | ==Study Description== | ||
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| Colspan="2" style="background:Gainsboro" align="center"|'''Study Description''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Study Description''' | ||
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| Style="width:30%"|'''Study Type'''|| Style="width:70%"| | | Style="width:30%"|'''Study Type'''|| Style="width:70%"|Interventional | ||
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| '''Study Phase''' || | | '''Study Phase''' ||Phase 4 | ||
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| Colspan="2" style="background:Gainsboro" align="center"|'''Study Design''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Study Design''' | ||
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| '''Allocation'''|| | | '''Allocation'''||Non-Randomized | ||
|- | |- | ||
| '''Endpoint'''|| | | '''Endpoint'''|| Safety Study | ||
|- | |- | ||
| '''Interventional Model'''|| | | '''Interventional Model'''||Single Group Assignment | ||
|- | |- | ||
| '''Masking'''|| | | '''Masking'''|| Open Label | ||
|- | |- | ||
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Details''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Study Details''' | ||
|- | |- | ||
| '''Primary Purpose'''|| | | '''Primary Purpose'''||Prevention | ||
|- | |- | ||
| '''Condition'''|| | | '''Condition'''||Previous Vka Treatment<br>Previous Proximal VTE | ||
|- | |- | ||
| '''Intervention'''|| | | '''Intervention'''||Echo Doppler (ED), DDimers and phone follow up<br>ED score, DDimers level and phone questionnary | ||
|- | |- | ||
| '''Study Arms'''|| | | '''Study Arms'''||Follow up<br>ED score and DDimer level of patients who have stopped their VKA treatment (after the first or the second previous proximal VTE).<br>Phone follow up for 2 years.<br>Intervention: Other: ED, DDimers and phone follow up | ||
|- | |- | ||
| '''Population Size'''|| | | '''Population Size'''||222 | ||
|- | |- | ||
|} | |} | ||
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/ | <span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00860106 .</span> | ||
==Eligibility Criteria== | ==Eligibility Criteria== | ||
===Inclusion Criteria=== | ===Inclusion Criteria=== | ||
*>18 and <80 years old | |||
*First or second treated proximal VTE event (+/- Pulmonary embolism) | |||
*Signed informed consent | |||
===Exclusion Criteria=== | ===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== | ==Outcomes== | ||
===Primary Outcomes=== | ===Primary Outcomes=== | ||
VTE event recurrence [ Time Frame: 0-2 years ] [ Designated as safety issue: Yes ] | |||
===Secondary Outcomes=== | ===Secondary Outcomes=== | ||
Not provided | |||
==Publications== | ==Publications== | ||
Latest revision as of 19:14, 25 September 2013
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D-Dimer Microchapters |
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Clinical Correlation |
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Clinical Trials |
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VAPRED Study On the Web |
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American Roentgen Ray Society Images of 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