Study identification

EU PAS number

EUPAS6616

Study ID

49877

Official title and acronym

Real-life anticoagulants benefit-risk in atrial fibrillation (AF) in France: VKA benefit-risk assessment before DOAC use for AF (ENGEL 1 VKA)

DARWIN EU® study

No

Study countries

France

Study description

The research question is to assess the baseline short-term, medium-term and long-term benefit-risk of vitamin K antagonists (VKA) for new users in the indication of atrial fibrillation (AF). The main objective is to estimate the 6-month, 1-year, and 3-year risk of major bleeding, arterial thrombotic events (stroke, systemic embolism), myocardial infarction (MI) and death during VKA exposure. This is a cohort study in a national healthcare claims and hospitalisations database including new users of VKA for AF between 01/01/2007 and 31/12/2011 with a follow-up until 31/12/2012, and 2 years history. VKA exposure will start at the date of first VKA dispensation (index date) and end at the date of VKA stop or at the end of follow-up. AF population will be defined as patients with full coverage for AF, hospitalisation or probabilistic AF information in the database, and without other probable cause of VKA prescription. Outcomes will be defined by primary diagnosis ICD-10 codes of hospital-discharge summary and date of death. The cumulative incidence of outcomes will be estimated using Kaplan-Meier estimate and 95% confidence interval.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Nicholas Moore

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable