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Comparison of Accidents and Their Circumstances With Oral Anticoagulants (CACAO)

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ClinicalTrials.gov Identifier: NCT02376777
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : June 28, 2017
University Hospital, Grenoble
Information provided by (Responsible Party):
CNGE IRMG Association

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
Cardiovascular Complications Hemorrhagic Disorders Embolism and Thrombosis Other: Follow up

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 Type : Observational
Actual Enrollment : 4162 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Accidents and Their Circumstances With Oral Anticoagulants. The CACAO Study
Actual Study Start Date : April 2014
Primary Completion Date : December 2016
Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Group/Cohort 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...)

Primary Outcome Measures :
  1. Clinical characteristics [ Time Frame: 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 :
  1. Bleeding events [ Time Frame: 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

  2. Thrombotic events [ Time Frame: 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

  3. Death [ Time Frame: at baseline, 3, 6, 9 and 12 months ]
    Describe the causes of death (including EP or cardiac events)

  4. Therapeutic classes [ Time Frame: 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

  5. Bleeding score [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Inclusion Criteria :

  • 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

Exclusion Criteria :

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376777

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
Gemenos, 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 practitioner
Saint Jean D'arvey, France
Office-based general practitioner
Saint-amant-tallende, France
Office-based practitioner
Saint-etienne, France
Office-based practitioner
Saint-jean-de-braye, France
Office-based practitioner
Saultain, France
Office-based general practitioner
Sellieres, France
Office-based practitioner
Seraincourt, France
Office-based general practitioner
Soisy-sous-montmorency, France
Office-based practitioner
St Georges D'orques, 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
Sponsors and Collaborators
CNGE IRMG Association
University Hospital, Grenoble
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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CNGE IRMG Association
ClinicalTrials.gov Identifier: NCT02376777     History of Changes
Other Study ID Numbers: DCIC 15 09
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017

Keywords provided by CNGE IRMG Association:
Atrial Fibrillation
Intracranial haemorrhage
Gastrointestinal haemorrhage
Myocardial infarction
Venous thrombosis
Primary care

Additional relevant MeSH terms:
Embolism and Thrombosis
Hemorrhagic Disorders
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases