Previous Vka TreatmentPhase 4VAPREDNCT00860106

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

A Phase 4 study testing ED, DDimers and phone follow up in people with Previous Vka Treatment and Previous Proximal VTE, run by University Hospital, Grenoble at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Previous Vka Treatment, Previous Proximal VTE
What is being tested?: ED, DDimers and phone follow up
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 222 participants
Where: 16 sitesFrance
Study dates: Mar 2005to May 2011
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

France16 sites

University Hospital
Amiens
Cabinet Medical
Annecy
HOSPITAL
Annecy
Cabinet Medical
Bourgoin
Cabinet Medical
Chalon-sur-Saône
HOSPITAL
Chambéry
Cabinet Medical
Crolles
Cabinet Medical
Fontaine
Vascular Medecine Departement - University Hospital of Grenoble
Grenoble, 38043
Cabinet Medical
Grenoble
Clinique Mutualiste les eaux claires
Grenoble
Cabinet Medical
Meylan
Cabinet Medical
Pontcharra
Cabinet Medical
Saint-Égrève
CMC Les Petites Roches
Saint-Hilaire
Cabinet Medical
Voiron

Other trials in France

About this study

Official title: Study of Predictive Echo Doppler Score and D-dimer Level in 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.

Read the detailed description

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

Conditions: Previous Vka Treatment, Previous Proximal VTE
Being tested: ED, DDimers and phone follow up
Keywords: VTE, VKA treatment, VKA treatment cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ED, DDimers and phone follow upOther
ED score, DDimers level and phone questionnary

Study groups in NCT00860106
Study group	Role	What they receive
Follow up	Other	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. Receives: Other: ED, DDimers and phone follow up

What is being measured

The primary outcome is the main question the study is designed to answer.

VTE event recurrence
Measured: 0-2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2005May 2011

First posted11 Mar 2009 (estimated)
Study startMar 2005
Primary completionMay 2010
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Previous Vka TreatmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 222 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00860106
Sponsor's protocol ID: DCIC 04 22
Acronym: VAPRED
Status last verified: Oct 2011
First submitted: 10 Mar 2009
Last updated: 12 Oct 2011
Results posted: No
Data monitoring committee: Yes

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. doi: 10.1056/NEJM200107193450302.
PubMed 11463010
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. doi: 10.7326/0003-4819-139-1-200307010-00008.
PubMed 12834314
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.
PubMed 10204659
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. doi: 10.1182/blood-2002-05-1416. Epub 2002 Sep 26.
PubMed 12393393
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. doi: 10.1001/jama.290.8.1071.
PubMed 12941680
Emmerich J, Fiessinger JN. Residual venous thrombosis and recurrent thromboembolism. Ann Intern Med. 2003 Aug 19;139(4):303; author reply 304. doi: 10.7326/0003-4819-139-4-200308190-00017. No abstract available.
PubMed 12965991
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.
PubMed 12152661
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. doi: 10.1056/NEJM199903253401201.
PubMed 10089183
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.
PubMed 12574808
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.
PubMed 11848459
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. doi: 10.1161/01.CIR.0000079162.69615.0F. Epub 2003 Jul 7.
PubMed 12847064
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. doi: 10.2144/97225bm10. No abstract available.
PubMed 9149858
Piovella F, Crippa L, Barone M, Vigano 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.
PubMed 12010666
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. doi: 10.7326/0003-4819-137-12-200212170-00008.
PubMed 12484710
Schulman S, Rhedin AS, Lindmarker P, Carlsson A, Larfars 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. doi: 10.1056/NEJM199506223322501.
PubMed 7760866

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Predictive Echo Doppler Score and D-dimer Level in Evaluation of the Thromboembolic Event Recurrence After Anticoagulant Treatment Cessation.
ClinicalTrials.gov ID: NCT00860106
Acronym / sponsor ID: VAPRED / DCIC 04 22
Conditions: Previous Vka Treatment, Previous Proximal VTE
Keywords: VTE, VKA treatment, VKA treatment cessation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 222 participants (actual)
Lead sponsor: University Hospital, GrenobleUniversity, hospital or other
Study start: Mar 2005
Primary completion: May 2010 (actual)
Study completion: May 2011 (actual)
First posted: 11 Mar 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Follow up	Other	Other: ED, DDimers and phone follow upED 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ED, DDimers and phone follow upED score, DDimers level and phone questionnary	Other	Follow up

Primary outcome

VTE event recurrence
Time frame: 0-2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
Background: PubMed 11463010Agnelli 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. doi: 10.1056/NEJM200107193450302.
Background: PubMed 12834314Agnelli 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. doi: 10.7326/0003-4819-139-1-200307010-00008.
Background: PubMed 10204659Bosson 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.
Background: PubMed 12393393Cushman 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. doi: 10.1182/blood-2002-05-1416. Epub 2002 Sep 26.
Background: PubMed 12941680Eichinger 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. doi: 10.1001/jama.290.8.1071.
Background: PubMed 12965991Emmerich J, Fiessinger JN. Residual venous thrombosis and recurrent thromboembolism. Ann Intern Med. 2003 Aug 19;139(4):303; author reply 304. doi: 10.7326/0003-4819-139-4-200308190-00017. No abstract available.
Background: PubMed 12152661Fattorini 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.
Background: PubMed 10089183Kearon 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. doi: 10.1056/NEJM199903253401201.
Background: PubMed 12574808Kuruvilla 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.
Background: PubMed 11848459Palareti 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.
Background: PubMed 12847064Palareti 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. doi: 10.1161/01.CIR.0000079162.69615.0F. Epub 2003 Jul 7.
Background: PubMed 9149858Pernod G, Mossuz P, Polack B. Optimized factor V gene mutation detection using buffy-coat direct PCR. Biotechniques. 1997 May;22(5):837, 840, 841. doi: 10.2144/97225bm10. No abstract available.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilles PERNOD, Professor principal investigator

University Hospital, Grenoble

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ED, DDimers and phone follow up in people with Previous Vka Treatment and Previous Proximal VTE, run by University Hospital, Grenoble at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VTE event recurrence (time frame: 0-2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00860106, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.