VAPRED Study: Difference between revisions

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Revision as of 17:14, 25 September 2013

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 09/20/2013 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 09/20/2013 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

Template:WH Template:WS

@@ Line 21: / Line 21: @@
 | '''End Date'''||May 2010
 |-
-| '''Status'''||
+| '''Status'''||phase 4
 |-
 |}
-<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT------.</span>
+<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00860106 .</span>
 ==Study Description==
@@ Line 32: / Line 32: @@
 | Colspan="2" style="background:Gainsboro" align="center"|'''Study Description'''
 |-
-| Style="width:30%"|'''Study Type'''|| Style="width:70%"|
+| Style="width:30%"|'''Study Type'''|| Style="width:70%"|Interventional
 |-
-| '''Study Phase''' ||
+| '''Study Phase''' ||Phase 4
 |-
 | Colspan="2" style="background:Gainsboro" align="center"|'''Study Design'''
 |-
-| '''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'''
 |-
-| '''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 09/20/2013 using the identification number NCT-----.</span>
+<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00860106 .</span>
 ==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==