CACAO: Comparison of Accidents and Their Circumstances With Oral Anticoagulants
Study Details
Study Description
Brief Summary
Differences in efficacy and safety between new oral anticoagulants (NOAC) and vitamin K antagonist (VKA) in real practice remain uncertain.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The method includes the use of a national prospective observational cohort, involving 444 general practitioners From april to december 2014, health data of any adult patient consulting a general practitioner and receiving an oral anticoagulant treatment has been entered in a database. Each patient received an information for agreement to participate to the study (agreement for stastical analysis of their health data during one year follow up).
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patient receiving NOAC Follow up of patients receiving new oral anticoagulants (NOAC) medication |
Other: 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 |
Other: 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...)
|
Outcome Measures
Primary Outcome Measures
- Clinical characteristics [at baseline]
The profile of patients receiving VKA or NOAC will be described by the following variables: Molecule, duration, dosage Indication: Atrial fibrillaton valvular or not / DVT / PE / Other, Prevention / Treatment Age, sex, weight, height Medication adherence ( as perceived by the GP ) Renal function CHA2DS2-VASc Score HAS-BLED Score RIETE score unstable INR Comorbidities: anemia, diabetes, kidney disease, liver disease, hypertension, heart failure, stroke, peripheral vascular desease, myocardial infarction (MI). Concomitant treatments: NSAIDs, antiplatelets, other treatments with potentials interactions
Secondary Outcome Measures
- Bleeding events [at baseline, 3, 6, 9 and 12 months]
Compare annual impact of bleeding events between patients receiving NOAC and VKA. Bleeding will be collected according to the International Society on Thrombosis and Haemostasis (ISTH) and BARC classification
- Thrombotic events [at baseline, 3, 6, 9 and 12 months]
Compare annual impact of thrombotic events (Ischemic stroke, DVT, PE, acute coronary syndrome) between patients receiving NOAC and VKA on further indications : non-valvular ACFA (excluding mitral regurgitation grade 3 and 4), preventing DVT / PE , DVT/ EP treatment
- Death [at baseline, 3, 6, 9 and 12 months]
Describe the causes of death (including EP or cardiac events)
- Therapeutic classes [at baseline, 3, 6, 9 and 12 months]
Describe the changes of therapeutic classes and reasons in NOAC and VKA treated population. Changes in indication for medicines, changes in mode and type of anticoagulant therapy
- Bleeding score [at baseline, 3, 6, 9 and 12 months]
Assess the relevance of different scores to predict the risk of bleeding. Comparison of the diagnostic performance of different classical scores by studying the corresponding AUC ROC curves
Eligibility Criteria
Criteria
Inclusion Criteria :
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Patient consulting a GP
-
Patient Whatever the reason for consultation
-
Aged >18 years
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Receiving oral anticoagulant treatment by NOAC (apixaban, dabigatran or rivaroxaban) or VKA (acenocoumarol, fluindione, or warfarin)
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Whatever the indication (prevention or treatment).
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Having the following indications for anticoagulant treatment : non-valvular atrial fibrillation, prevention of DVT / PE (excluding orthopedic post-surgery) treatment DVT / PE
Exclusion Criteria :
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Aged <18 years
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Receiving concomitant injectable anticoagulant treatment (including relay phase)
-
Follow up impossible.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Office-based practitioner | Albens | France | ||
| 2 | Office-based practitioner | Bordeaux | France | ||
| 3 | Office-based practitioner | Chablis | France | ||
| 4 | Office-based general practitioner | Dessenheim | France | ||
| 5 | Office-based general practitioner | Dijon | France | ||
| 6 | Office-based practitioner | Flumet | France | ||
| 7 | Office-based practitioner | Gemenos | France | ||
| 8 | Office-based general practitioner | Grenay | France | ||
| 9 | Office-based general practitioner | Guesnain | France | ||
| 10 | Office-based general practitioner | Hatten | France | ||
| 11 | Office-based practitioner | Hinx | France | ||
| 12 | Office-based practitioner | La Madeleine | France | ||
| 13 | Office-based practitioner | Les Marches | France | ||
| 14 | Office-based practitioner | Limoges | France | ||
| 15 | Office-based practitioner | Mulsanne | France | ||
| 16 | Office-based practitioner | Outreau | France | ||
| 17 | Office-based general practitioner | Paris | France | ||
| 18 | Office-based general practitioner | Rupt-sur-moselle | France | ||
| 19 | Office-based practitioner | Saint Jean D'arvey | France | ||
| 20 | Office-based general practitioner | Saint-amant-tallende | France | ||
| 21 | Office-based practitioner | Saint-etienne | France | ||
| 22 | Office-based practitioner | Saint-jean-de-braye | France | ||
| 23 | Office-based practitioner | Saultain | France | ||
| 24 | Office-based general practitioner | Sellieres | France | ||
| 25 | Office-based practitioner | Seraincourt | France | ||
| 26 | Office-based general practitioner | Soisy-sous-montmorency | France | ||
| 27 | Office-based practitioner | St Georges D'orques | France | ||
| 28 | Office-based general practioner | Strasbourg | France | ||
| 29 | Office-based practitioner | Tournus | France | ||
| 30 | Office-based general practitioner | Tours | France | ||
| 31 | Office-based practitioner | Villeurbanne | France | ||
| 32 | Office-based practitioner | Vitry-sur-seine | France | ||
| 33 | Office-based general practitioner | Vourey | France |
Sponsors and Collaborators
- CNGE IRMG Association
- Floralis
- University Hospital, Grenoble
Investigators
- Principal Investigator: Joël COGNEAU, MD, IRMG
- Study Director: Paul FRAPPE, MD, University of Saint-Etienne
- Study Director: Jean-Pierre JACQUET, MD, University of Grenoble
- Study Director: Jean-Luc BOSSON, MD PhD, University of Grenoble
- Study Director: François Lacoin, MD, IRMG
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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. Review.
- 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.
- Kearon C. Natural history of venous thromboembolism. Circulation. 2003 Jun 17;107(23 Suppl 1):I22-30. Review.
- Larsen TB, Rasmussen LH, Skjøth F, Due KM, Callréus 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.
- 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. Erratum in: Anesthesiology 2002 Aug;97(2):531.
- 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. Review.
- 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.
- 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.
- 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. Review.
- 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.
- DCIC 15 09