Comparison of Accidents and Their Circumstances With Oral Anticoagulants

Study Overview
=================
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.

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.

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

Conditions
-----------------
Cardiovascular Complications, Hemorrhagic Disorders, Embolism and Thrombosis

Intervention / Treatment
-----------------
* Other: Follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient receiving NOAC<br>Follow up of patients receiving new oral anticoagulants (NOAC) medication | Other: Follow up<br>* each three months during one year of follow up, general practioners will entered health data in database (hemorrhagic events, changes of medication, biological data...)<br>|
| Patient receiving VKA<br>Follow up of patients receiving vitamin K antagonist (VKA) medication | Other: Follow up<br>* each three months during one year of follow up, general practioners will entered health data in database (hemorrhagic events, changes of medication, biological data...)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anticoagulants, Antithrombins, Atrial Fibrillation, Intracranial haemorrhage, Gastrointestinal haemorrhage, Myocardial infarction, Stroke, Venous thrombosis, Primary care