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Completed

NCT Number: NCT02376777

Comparison of Accidents and Their Circumstances With Oral Anticoagulants

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.

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Key information

Conditions

Cardiovascular Complications Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Digestive System Diseases Embolism and Thrombosis Gastrointestinal Diseases Gastrointestinal Hemorrhage Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Infarction Intracranial Hemorrhages Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Office-based practitioner, Albens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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...)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CNGE IRMG Association

Other

Collaborators

  • Floralis
  • University Hospital, Grenoble

Registry information

Official study title

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

Acronym: CACAO

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 3, 2015
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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