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

June 27, 2017 updated by: CNGE IRMG Association

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

4162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Albens, France
        • Office-based practitioner
      • Bordeaux, France
        • Office-based practitioner
      • Chablis, France
        • Office-based practitioner
      • Dessenheim, France
        • Office-based general practitioner
      • Dijon, France
        • Office-based general practitioner
      • Flumet, France
        • Office-based practitioner
      • Gemenos, France
        • Office-based practitioner
      • Grenay, France
        • Office-based general practitioner
      • Guesnain, France
        • Office-based general practitioner
      • Hatten, France
        • Office-based general 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 practitioner
      • Paris, France
        • Office-based general practitioner
      • Rupt-sur-moselle, France
        • Office-based general practitioner
      • Saint Jean D'arvey, France
        • Office-based practitioner
      • Saint-amant-tallende, France
        • Office-based general practitioner
      • Saint-etienne, France
        • Office-based practitioner
      • Saint-jean-de-braye, France
        • Office-based practitioner
      • Saultain, France
        • Office-based practitioner
      • Sellieres, France
        • Office-based general practitioner
      • Seraincourt, France
        • Office-based practitioner
      • Soisy-sous-montmorency, France
        • Office-based general practitioner
      • St Georges D'orques, France
        • Office-based practitioner
      • Strasbourg, France
        • Office-based general practioner
      • Tournus, France
        • Office-based practitioner
      • Tours, France
        • Office-based general practitioner
      • Villeurbanne, France
        • Office-based practitioner
      • Vitry-sur-seine, France
        • Office-based practitioner
      • Vourey, France
        • Office-based general practitioner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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...)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CNGE IRMG Association

Collaborators

University Hospital, Grenoble
Floralis

Investigators

  • Study Director: Paul FRAPPE, MD, University of Saint-Etienne
  • Principal Investigator: Joël COGNEAU, MD, IRMG
  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 27, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 15 09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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