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Cardiovascular ComplicationsCACAONCT02376777

Comparison of Accidents and Their Circumstances With Oral Anticoagulants

An observational study of Cardiovascular Complications and Hemorrhagic Disorders, run by CNGE IRMG Association at 33 sites in France.

Completed

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

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Follow up
Type of treatment
Pill or oral medicine
How many people
4,162 participants
Where
33 sitesFrance
Study dates
Apr 2014to Jun 2017
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

France33 sites

  • Office-based practitioner

    Albens

  • Office-based practitioner

    Bordeaux

  • Office-based practitioner

    Chablis

  • Office-based general practitioner

    Dessenheim

  • Office-based general practitioner

    Dijon

  • Office-based practitioner

    Flumet

  • Office-based practitioner

    Gémenos

  • Office-based general practitioner

    Grenay

  • Office-based general practitioner

    Guesnain

  • Office-based general practitioner

    Hatten

  • Office-based practitioner

    Hinx

  • Office-based practitioner

    La Madeleine

  • Office-based practitioner

    Les Marches

  • Office-based practitioner

    Limoges

  • Office-based practitioner

    Mulsanne

  • Office-based practitioner

    Outreau

  • Office-based general practitioner

    Paris

  • Office-based general practitioner

    Rupt-sur-Moselle

  • Office-based general practitioner

    Saint-Amant-Tallende

  • Office-based practitioner

    Saint-Etienne

  • Office-based practitioner

    Saint-Georges-dOrques

  • Office-based practitioner

    Saint-Jean-d'Arvey

  • Office-based practitioner

    Saint-Jean-de-Braye

  • Office-based practitioner

    Saultain

  • Office-based general practitioner

    Sellières

  • Office-based practitioner

    Seraincourt

  • Office-based general practitioner

    Soisy-sous-Montmorency

  • Office-based general practioner

    Strasbourg

  • Office-based practitioner

    Tournus

  • Office-based general practitioner

    Tours

  • Office-based practitioner

    Villeurbanne

  • Office-based practitioner

    Vitry-sur-Seine

  • Office-based general practitioner

    Vourey

Other trials in France

About this study

Official title: Comparison of Accidents and Their Circumstances With Oral Anticoagulants. The CACAO Study

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.

Read the 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.

Being tested
Follow up
Keywords
Anticoagulants, Antithrombins, Atrial Fibrillation, Intracranial haemorrhage, Gastrointestinal haemorrhage, Myocardial infarction, Stroke, Venous thrombosis, Primary care
Medical subject headings
Hemorrhagic Disorders, Embolism and Thrombosis, Atrial Fibrillation, Intracranial Hemorrhages, Gastrointestinal Hemorrhage, Myocardial Infarction, Stroke, Venous Thrombosis

What participants receive

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

  • Follow upOther

    each three months during one year of follow up, general practioners will entered health data in database (hemorrhagic events, changes of medication, biological data...)

Study groups in NCT02376777
Study groupRoleWhat they receive
Patient receiving NOACFollow up of patients receiving new oral anticoagulants (NOAC) medication
Receives: Other: Follow up
Patient receiving VKAFollow up of patients receiving vitamin K antagonist (VKA) medication
Receives: Other: Follow up

What is being measured

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

  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

    Measured: at baseline

Secondary outcomes (5)

  1. Bleeding events

    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

    Measured: at baseline, 3, 6, 9 and 12 months

  2. Thrombotic events

    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

    Measured: at baseline, 3, 6, 9 and 12 months

  3. Death

    Describe the causes of death (including EP or cardiac events)

    Measured: at baseline, 3, 6, 9 and 12 months

  4. Therapeutic classes

    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

    Measured: at baseline, 3, 6, 9 and 12 months

  5. Bleeding score

    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

    Measured: at baseline, 3, 6, 9 and 12 months

Timeline

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

  1. First posted3 Mar 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionDec 2016
  4. Study completionJun 2017

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02376777
Sponsor's protocol ID
DCIC 15 09
Acronym
CACAO
Status last verified
Jun 2017
First submitted
26 Feb 2015
Last updated
28 Jun 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12814982

  • 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.

    PubMed 22315271

  • 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.

    PubMed 11981154

  • 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.

    PubMed 19718469

  • 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.

    PubMed 21349898

  • 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.

    PubMed 24315724

  • 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.

    PubMed 22537354

  • 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.

    PubMed 22928173

  • 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.

    PubMed 22231617

  • 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.

    PubMed 23562920

  • 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.

    PubMed 15842354

  • Gaboreau Y, Frappe P, Vermorel C, Foote A, Bosson JL, Pernod G; CACAO study investigators. Patients treated with vitamin K oral anticoagulants in family practice: a new approach to bleeding risk assessment. An ancillary study by the CACAO prospective general practice cohort. Fam Pract. 2024 Dec 2;41(6):932-940. doi: 10.1093/fampra/cmae052.

    PubMed 39446561

  • 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.

    PubMed 38281089

  • 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.

    PubMed 32152017

  • 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.

    PubMed 28384199

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Complications and Hemorrhagic Disorders, run by CNGE IRMG Association at 33 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 6 inclusion and 3 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 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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.

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?

Clinical characteristics (time frame: at baseline). 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 NCT02376777, which also lists 15 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 28 Jun 2017.

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