Comparison of Accidents and Their Circumstances With Oral Anticoagulants

NCT02376777 | Completed

• 1 other identifier: DCIC 15 09
• Study Type: observational
• Target: 4,162
• Locations: 1 country
• Sites: 33

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.

Conditions

Cardiovascular Complications; Hemorrhagic Disorders; Embolism and Thrombosis

Keywords

Anticoagulants; Antithrombins; Atrial Fibrillation; Intracranial haemorrhage; Gastrointestinal haemorrhage; Myocardial infarction; Stroke; Venous thrombosis; Primary care

Outcome Measures

Primary Outcomes (1)

• Clinical characteristics

  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

  at baseline

Secondary Outcomes (5)

• Bleeding events

  at baseline, 3, 6, 9 and 12 months

• Thrombotic events

  at baseline, 3, 6, 9 and 12 months

• Death

  at baseline, 3, 6, 9 and 12 months

• Therapeutic classes

  at baseline, 3, 6, 9 and 12 months

• Bleeding score

  at baseline, 3, 6, 9 and 12 months

Study Arms (2)

Patient receiving NOAC

Follow up of patients receiving new oral anticoagulants (NOAC) medication

Other: Follow up

Patient receiving VKA

Follow up of patients receiving vitamin K antagonist (VKA) medication

Other: Follow up

Interventions

Follow up OTHER

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 NOAC; Patient receiving VKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients with anticoagulant medication consulting their general practitioner will be included (N=7846), and after stratification, 4162 patients will be followed

You may qualify if:

• Patient consulting a GP
• 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

You may not qualify if:

• Aged \<18 years
• Receiving concomitant injectable anticoagulant treatment (including relay phase)
• Follow up impossible.

Sponsors & Collaborators

• CNGE IRMG Association: lead
• Floralis: collaborator
• University Hospital, Grenoble: collaborator

Study Sites (33)

Office-based practitioner

Albens, France

Location

Office-based practitioner

Bordeaux, France

Location

Office-based practitioner

Chablis, France

Location

Office-based general practitioner

Dessenheim, France

Location

Office-based general practitioner

Dijon, France

Location

Office-based practitioner

Flumet, France

Location

Office-based practitioner

Gémenos, France

Location

Office-based general practitioner

Grenay, France

Location

Office-based general practitioner

Guesnain, France

Location

Office-based general practitioner

Hatten, France

Location

Office-based practitioner

Hinx, France

Location

Office-based practitioner

La Madeleine, France

Location

Office-based practitioner

Les Marches, France

Location

Office-based practitioner

Limoges, France

Location

Office-based practitioner

Mulsanne, France

Location

Office-based practitioner

Outreau, France

Location

Office-based general practitioner

Paris, France

Location

Office-based general practitioner

Rupt-sur-Moselle, France

Location

Office-based general practitioner

Saint-Amant-Tallende, France

Location

Office-based practitioner

Saint-Etienne, France

Location

Office-based practitioner

Saint-Georges-dOrques, France

Location

Office-based practitioner

Saint-Jean-d'Arvey, France

Location

Office-based practitioner

Saint-Jean-de-Braye, France

Location

Office-based practitioner

Saultain, France

Location

Office-based general practitioner

Sellières, France

Location

Office-based practitioner

Seraincourt, France

Location

Office-based general practitioner

Soisy-sous-Montmorency, France

Location

Office-based general practioner

Strasbourg, France

Location

Office-based practitioner

Tournus, France

Location

Office-based general practitioner

Tours, France

Location

Office-based practitioner

Villeurbanne, France

Location

Office-based practitioner

Vitry-sur-Seine, France

Location

Office-based general practitioner

Vourey, France

Location

Related Publications (14)

• 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.

  PMID: 12814982 BACKGROUND

• 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.

  PMID: 22315271 BACKGROUND

• 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.

  PMID: 11981154 BACKGROUND

• 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.

  PMID: 19718469 BACKGROUND

• 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.

  PMID: 21349898 BACKGROUND

• 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.

  PMID: 24315724 BACKGROUND

• 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.

  PMID: 22537354 BACKGROUND

• 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.

  PMID: 22928173 BACKGROUND

• 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.

  PMID: 22231617 BACKGROUND

• 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.

  PMID: 23562920 BACKGROUND

• 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.

  PMID: 15842354 BACKGROUND

• 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.

  PMID: 38281089 DERIVED

• 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.

  PMID: 32152017 DERIVED

• 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.

  PMID: 28384199 DERIVED

MeSH Terms

Conditions

Hemorrhagic Disorders; Embolism and Thrombosis; Atrial Fibrillation; Intracranial Hemorrhages; Gastrointestinal Hemorrhage; Myocardial Infarction; Stroke; Venous Thrombosis

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Myocardial Ischemia; Infarction; Ischemia; Necrosis; Thrombosis

Study Officials

• Joël COGNEAU, MD

  IRMG

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 3, 2015
• Study Start: April 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 28, 2017

Record last verified: 2017-06

Locations

FR (33)