Comparison of Accidents and Their Circumstances With Oral Anticoagulants

Completed

• Conditions: Hemorrhagic Disorders; Embolism and Thrombosis; Cardiovascular Complications
• Interventions: Other: Follow up

• Registration Number: NCT02376777
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Primary Completion: 2016-12
• Status Verified: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient receiving NOAC	Follow up	Follow up of patients receiving new oral anticoagulants (NOAC) medication
Patient receiving VKA	Follow up	Follow up of patients receiving vitamin K antagonist (VKA) medication

Primary Outcome Measures

Name	Time	Method
Clinical characteristics	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

Name	Time	Method
Therapeutic classes	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
Bleeding score	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
Bleeding events	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
Thrombotic events	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
Death	at baseline, 3, 6, 9 and 12 months	Describe the causes of death (including EP or cardiac events)

Trial Locations

Locations (3)

Office-based general practitioner; 🇫🇷 Vourey, France

Office-based practitioner; 🇫🇷 Vitry-sur-seine, France

Office-based general practioner; 🇫🇷 Strasbourg, France