Comparison of Accidents and Their Circumstances With Oral Anticoagulants
NCT ID: NCT02376777
Last Updated: 2017-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4162 participants
OBSERVATIONAL
2014-04-30
2017-06-30
Brief Summary
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The few existing ambulatory studies did not answer all NOAC specific issues, such as prescription habits and motives, patients characteristics, biological monitoring, as well as the occurrence of major and minor thromboembolic events, especially in France where warfarin is less frequently prescribed.
Therefore, in order to describe clinical and follow up characteristics of patients receiving oral anticoagulants, the investigators will set up a national prospective cohort to compare the occurrence of thromboembolic events between VKA and NOAC in primary care.
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Detailed Description
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In March 2015, half of those patients will be chosen (stratification), using a matched stratification process, and will be followed up over one year. Every three months, data regarding the occurrence of therapeutics changes, episodes of excessive bleeding, and thromboembolic events will be collected by general practitioners.
The data will be analysed by: - describing the characteristics of patients receiving oral anticoagulant treatment; - describing the changes of medications over the year ; - comparing the occurrence of episodes of excessive bleeding ; - comparing the occurrence of thromboembolic events in patients using VKA versus patients using NOAC.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient receiving NOAC
Follow up of patients receiving new oral anticoagulants (NOAC) medication
Follow up
each three months during one year of follow up, general practioners will entered health data in database (hemorrhagic events, changes of medication, biological data...)
Patient receiving VKA
Follow up of patients receiving vitamin K antagonist (VKA) medication
Follow up
each three months during one year of follow up, general practioners will entered health data in database (hemorrhagic events, changes of medication, biological data...)
Interventions
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Follow up
each three months during one year of follow up, general practioners will entered health data in database (hemorrhagic events, changes of medication, biological data...)
Eligibility Criteria
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Inclusion Criteria
* Patient Whatever the reason for consultation
* Aged \>18 years
* Receiving oral anticoagulant treatment by NOAC (apixaban, dabigatran or rivaroxaban) or VKA (acenocoumarol, fluindione, or warfarin)
* Whatever the indication (prevention or treatment).
* Having the following indications for anticoagulant treatment : non-valvular atrial fibrillation, prevention of DVT / PE (excluding orthopedic post-surgery) treatment DVT / PE
Exclusion Criteria
* Receiving concomitant injectable anticoagulant treatment (including relay phase)
* Follow up impossible.
18 Years
ALL
No
Sponsors
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Floralis
INDUSTRY
University Hospital, Grenoble
OTHER
CNGE IRMG Association
OTHER
Responsible Party
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Principal Investigators
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Joël COGNEAU, MD
Role: PRINCIPAL_INVESTIGATOR
IRMG
Paul FRAPPE, MD
Role: STUDY_DIRECTOR
University of Saint-Etienne
Jean-Pierre JACQUET, MD
Role: STUDY_DIRECTOR
University of Grenoble
Jean-Luc BOSSON, MD PhD
Role: STUDY_DIRECTOR
University of Grenoble
François Lacoin, MD
Role: STUDY_DIRECTOR
IRMG
Locations
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Office-based practitioner
Albens, , France
Office-based practitioner
Bordeaux, , France
Office-based practitioner
Chablis, , France
Office-based general practitioner
Dessenheim, , France
Office-based general practitioner
Dijon, , France
Office-based practitioner
Flumet, , France
Office-based practitioner
Gémenos, , France
Office-based general practitioner
Grenay, , France
Office-based general practitioner
Guesnain, , France
Office-based general practitioner
Hatten, , France
Office-based practitioner
Hinx, , France
Office-based practitioner
La Madeleine, , France
Office-based practitioner
Les Marches, , France
Office-based practitioner
Limoges, , France
Office-based practitioner
Mulsanne, , France
Office-based practitioner
Outreau, , France
Office-based general practitioner
Paris, , France
Office-based general practitioner
Rupt-sur-Moselle, , France
Office-based general practitioner
Saint-Amant-Tallende, , France
Office-based practitioner
Saint-Etienne, , France
Office-based practitioner
Saint-Georges-dOrques, , France
Office-based practitioner
Saint-Jean-d'Arvey, , France
Office-based practitioner
Saint-Jean-de-Braye, , France
Office-based practitioner
Saultain, , France
Office-based general practitioner
Sellières, , France
Office-based practitioner
Seraincourt, , France
Office-based general practitioner
Soisy-sous-Montmorency, , France
Office-based general practioner
Strasbourg, , France
Office-based practitioner
Tournus, , France
Office-based general practitioner
Tours, , France
Office-based practitioner
Villeurbanne, , France
Office-based practitioner
Vitry-sur-Seine, , France
Office-based general practitioner
Vourey, , France
Countries
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References
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Kearon C. Natural history of venous thromboembolism. Circulation. 2003 Jun 17;107(23 Suppl 1):I22-30. doi: 10.1161/01.CIR.0000078464.82671.78.
You JJ, Singer DE, Howard PA, Lane DA, Eckman MH, Fang MC, Hylek EM, Schulman S, Go AS, Hughes M, Spencer FA, Manning WJ, Halperin JL, Lip GYH. Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e531S-e575S. doi: 10.1378/chest.11-2304.
Mantilla CB, Horlocker TT, Schroeder DR, Berry DJ, Brown DL. Frequency of myocardial infarction, pulmonary embolism, deep venous thrombosis, and death following primary hip or knee arthroplasty. Anesthesiology. 2002 May;96(5):1140-6. doi: 10.1097/00000542-200205000-00017.
Galanaud JP, Sevestre-Pietri MA, Bosson JL, Laroche JP, Righini M, Brisot D, Boge G, van Kien AK, Gattolliat O, Bettarel-Binon C, Gris JC, Genty C, Quere I; OPTIMEV-SFMV Investigators. Comparative study on risk factors and early outcome of symptomatic distal versus proximal deep vein thrombosis: results from the OPTIMEV study. Thromb Haemost. 2009 Sep;102(3):493-500. doi: 10.1160/TH09-01-0053.
Douketis J, Tosetto A, Marcucci M, Baglin T, Cosmi B, Cushman M, Kyrle P, Poli D, Tait RC, Iorio A. Risk of recurrence after venous thromboembolism in men and women: patient level meta-analysis. BMJ. 2011 Feb 24;342:d813. doi: 10.1136/bmj.d813.
Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014 Mar 15;383(9921):955-62. doi: 10.1016/S0140-6736(13)62343-0. Epub 2013 Dec 4.
Miller CS, Grandi SM, Shimony A, Filion KB, Eisenberg MJ. Meta-analysis of efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus warfarin in patients with atrial fibrillation. Am J Cardiol. 2012 Aug 1;110(3):453-60. doi: 10.1016/j.amjcard.2012.03.049. Epub 2012 Apr 24.
Adam SS, McDuffie JR, Ortel TL, Williams JW Jr. Comparative effectiveness of warfarin and new oral anticoagulants for the management of atrial fibrillation and venous thromboembolism: a systematic review. Ann Intern Med. 2012 Dec 4;157(11):796-807. doi: 10.7326/0003-4819-157-10-201211200-00532.
Uchino K, Hernandez AV. Dabigatran association with higher risk of acute coronary events: meta-analysis of noninferiority randomized controlled trials. Arch Intern Med. 2012 Mar 12;172(5):397-402. doi: 10.1001/archinternmed.2011.1666. Epub 2012 Jan 9.
Larsen TB, Rasmussen LH, Skjoth F, Due KM, Callreus T, Rosenzweig M, Lip GY. Efficacy and safety of dabigatran etexilate and warfarin in "real-world" patients with atrial fibrillation: a prospective nationwide cohort study. J Am Coll Cardiol. 2013 Jun 4;61(22):2264-73. doi: 10.1016/j.jacc.2013.03.020. Epub 2013 Apr 3.
Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
Gaboreau Y, Frappe P, Vermorel C, Foote A, Bosson JL, Pernod G; CACAO study investigators. Oral anticoagulant safety in family practice: prognostic accuracy of Bleeding Risk Scores (from the CACAO study). Fam Pract. 2024 Feb 28;41(1):9-17. doi: 10.1093/fampra/cmad121.
Frappe P, Cogneau J, Gaboreau Y, Abenhaim N, Bayen M, Guichard C, Jacquet JP, Lacoin F, Liebart S, Bertoletti L, Bosson JL; CACAO study investigators. Anticoagulants' Safety and Effectiveness in General Practice: A Nationwide Prospective Cohort Study. Ann Fam Med. 2020 Mar;18(2):131-138. doi: 10.1370/afm.2495.
Frappe P, Cogneau J, Gaboreau Y, Abenhaim N, Bayen M, Calafiore M, Guichard C, Jacquet JP, Lacoin F, Bertoletti L; CACAO study investigators. Areas of improvement in anticoagulant safety. Data from the CACAO study, a cohort in general practice. PLoS One. 2017 Apr 6;12(4):e0175167. doi: 10.1371/journal.pone.0175167. eCollection 2017.
Other Identifiers
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DCIC 15 09
Identifier Type: -
Identifier Source: org_study_id
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