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Echo Doppler (ED )Score and D-Dimer (DD) Level in the Evaluation of VTE Recurrence After Anticoagulant Treatment Cessation (VAPRED)
This study is ongoing, but not recruiting participants.
First Received: March 10, 2009   No Changes Posted
Sponsored by: University Hospital, Grenoble
Information provided by: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00860106
  Purpose

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.


Condition Intervention Phase
Previous Vka Treatment
Previous Proximal VTE
 Other: ED, DDimers and phone follow up
 Phase IV

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Study of Predictive Echo Doppler Score and D-Dimer Level in Evaluation of the Thromboembolic Event Recurrence After Anticoagulant Treatment Cessation.

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • VTE event recurrence [ Time Frame: 0-2 years ] [ Designated as safety issue: Yes ]

Enrollment: 222
Study Start Date: March 2005
Estimated Study Completion Date: March 2010
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

 Other: ED, DDimers and phone follow up
ED score, DDimers level and phone questionnary

Detailed Description:

DDimer levels are centralized in University Hospital of Grenoble at the end of the study

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00860106

Locations
France
Vascular Medecine Departement - University Hospital of Grenoble
GRENOBLE, France, 38043
Clinique Mutualiste les eaux claires
GRENOBLE, France
Cabinet Medical
GRENOBLE, France
CMC Les Petites Roches
SAINT HILAIRE DU TOUVET, France
HOSPITAL
ANNECY, France
HOSPITAL
CHAMBERY, France
Cabinet Medical
GRENOBLE, France
Cabinet Medical
GRENOBLE, France
Cabinet Medical
GRENOBLE, France
Cabinet Medical
GRENOBLE, France
Cabinet Medical
GRENOBLE, France
Cabinet Medical
MEYLAN, France
Cabinet Medical
GRENOBLE, France
Cabinet Medical
GRENOBLE, France
Cabinet Medical
VOIRON, France
Cabinet Medical
ANNECY, France
Cabinet Medical
FONTAINE, France
Cabinet Medical
CROLLES, France
University Hospital
AMIENS, France
Cabinet Medical
GRENOBLE, France
Cabinet Medical
BOURGOIN JALLIEU, France
Cabinet Medical
CHALON SUR SAONE, France
Cabinet Medical
PONTCHARRA, France
Cabinet Medical
SAINT EGREVE, France
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Gilles PERNOD, Professor University Hospital, Grenoble
  More Information

Publications:
Agnelli G, Prandoni P, Santamaria MG, Bagatella P, Iorio A, Bazzan M, Moia M, Guazzaloca G, Bertoldi A, Tomasi C, Scannapieco G, Ageno W; Warfarin Optimal Duration Italian Trial Investigators. Three months versus one year of oral anticoagulant therapy for idiopathic deep venous thrombosis. Warfarin Optimal Duration Italian Trial Investigators. N Engl J Med. 2001 Jul 19;345(3):165-9.
Agnelli G, Prandoni P, Becattini C, Silingardi M, Taliani MR, Miccio M, Imberti D, Poggio R, Ageno W, Pogliani E, Porro F, Zonzin P; Warfarin Optimal Duration Italian Trial Investigators. Extended oral anticoagulant therapy after a first episode of pulmonary embolism. Ann Intern Med. 2003 Jul 1;139(1):19-25.
Bosson JL, Riachi M, Pichot O, Michoud E, Carpentier PH, Franco A. Diameters of acute proximal and distal deep venous thrombosis of the lower limbs. Int Angiol. 1998 Dec;17(4):260-7.
Cushman M, Folsom AR, Wang L, Aleksic N, Rosamond WD, Tracy RP, Heckbert SR. Fibrin fragment D-dimer and the risk of future venous thrombosis. Blood. 2003 Feb 15;101(4):1243-8. Epub 2002 Sep 26.
Eichinger S, Minar E, Bialonczyk C, Hirschl M, Quehenberger P, Schneider B, Weltermann A, Wagner O, Kyrle PA. D-dimer levels and risk of recurrent venous thromboembolism. JAMA. 2003 Aug 27;290(8):1071-4.
Emmerich J, Fiessinger JN. Residual venous thrombosis and recurrent thromboembolism. Ann Intern Med. 2003 Aug 19;139(4):303; author reply 304. No abstract available.
Fattorini A, Crippa L, Vigano' D'Angelo S, Pattarini E, D'Angelo A. Risk of deep vein thrombosis recurrence: high negative predictive value of D-dimer performed during oral anticoagulation. Thromb Haemost. 2002 Jul;88(1):162-3. No abstract available.
Kearon C, Gent M, Hirsh J, Weitz J, Kovacs MJ, Anderson DR, Turpie AG, Green D, Ginsberg JS, Wells P, MacKinnon B, Julian JA. A comparison of three months of anticoagulation with extended anticoagulation for a first episode of idiopathic venous thromboembolism. N Engl J Med. 1999 Mar 25;340(12):901-7. Erratum in: N Engl J Med 1999 Jul 22;341(4):298.
Kuruvilla J, Wells PS, Morrow B, MacKinnon K, Keeney M, Kovacs MJ. Prospective assessment of the natural history of positive D-dimer results in persons with acute venous thromboembolism (DVT or PE). Thromb Haemost. 2003 Feb;89(2):284-7.
Palareti G, Legnani C, Cosmi B, Guazzaloca G, Pancani C, Coccheri S. Risk of venous thromboembolism recurrence: high negative predictive value of D-dimer performed after oral anticoagulation is stopped. Thromb Haemost. 2002 Jan;87(1):7-12.
Palareti G, Legnani C, Cosmi B, Valdre L, Lunghi B, Bernardi F, Coccheri S. Predictive value of D-dimer test for recurrent venous thromboembolism after anticoagulation withdrawal in subjects with a previous idiopathic event and in carriers of congenital thrombophilia. Circulation. 2003 Jul 22;108(3):313-8. Epub 2003 Jul 7.
Pernod G, Mossuz P, Polack B. Optimized factor V gene mutation detection using buffy-coat direct PCR. Biotechniques. 1997 May;22(5):837, 840, 841. No abstract available.
Piovella F, Crippa L, Barone M, Viganò D'Angelo S, Serafini S, Galli L, Beltrametti C, D'Angelo A. Normalization rates of compression ultrasonography in patients with a first episode of deep vein thrombosis of the lower limbs: association with recurrence and new thrombosis. Haematologica. 2002 May;87(5):515-22.
Prandoni P, Lensing AW, Prins MH, Bernardi E, Marchiori A, Bagatella P, Frulla M, Mosena L, Tormene D, Piccioli A, Simioni P, Girolami A. Residual venous thrombosis as a predictive factor of recurrent venous thromboembolism. Ann Intern Med. 2002 Dec 17;137(12):955-60. Summary for patients in: Ann Intern Med. 2002 Dec 17;137(12):I32.
Schulman S, Rhedin AS, Lindmarker P, Carlsson A, Lärfars G, Nicol P, Loogna E, Svensson E, Ljungberg B, Walter H. A comparison of six weeks with six months of oral anticoagulant therapy after a first episode of venous thromboembolism. Duration of Anticoagulation Trial Study Group. N Engl J Med. 1995 Jun 22;332(25):1661-5.
Schulman S, Granqvist S, Holmström M, Carlsson A, Lindmarker P, Nicol P, Eklund SG, Nordlander S, Lärfars G, Leijd B, Linder O, Loogna E. The duration of oral anticoagulant therapy after a second episode of venous thromboembolism. The Duration of Anticoagulation Trial Study Group. N Engl J Med. 1997 Feb 6;336(6):393-8.
Schulman S. Clinical practice. Care of patients receiving long-term anticoagulant therapy. N Engl J Med. 2003 Aug 14;349(7):675-83. Review. No abstract available.
Sebastian JL, Torre DM. Residual venous thrombosis and recurrent thromboembolism. Ann Intern Med. 2003 Aug 19;139(4):303; author reply 304. No abstract available.

Responsible Party: University Hospital of Grenoble ( Gilles PERNOD / Professor )
Study ID Numbers: DCIC 04 22
Study First Received: March 10, 2009
Last Updated: March 10, 2009
ClinicalTrials.gov Identifier: NCT00860106     History of Changes
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Grenoble:
VTE
VKA treatment
VKA treatment cessation

Study placed in the following topic categories:
Anticoagulants
Fibrin fragment D
Recurrence

Additional relevant MeSH terms:
Anticoagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009



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