Treatment of Acute Coronary Syndrome (ACS). Clinical Trial
Official title:
REalWorld Insights on the INitiation and Treatment Duration of ticagrEloR & Other Oral Antiplatelets in Patients With Acute Coronary Syndrome in Belgium/Luxembourg (REWINDER)
REWINDER is a multinational, multicentre, non-interventional, retrospective study of
patients treated with an oral antiplatelet (ticagrelor, prasugrel or clopidogrel) while in
hospital after an acute coronary syndrome (ACS) event, to be conducted in Belgium and
Luxembourg.
Primary objective is to evaluate the actual treatment persistence with oral antiplatelets
(OAP) after an ACS in the clinical practice in Belgium and Luxembourg.
The main secondary objectives are to describe the most frequent reasons for OAP treatment
switch, discontinuation or reinitiation; to identify the decisionmakers in the OAP treatment
changes and to characterize the patient profile in terms of demographics, diagnosis,
management strategies, comorbidities and concomitant medications to identify any association
between patient profile and treatment duration.
Treatment of acute coronary syndrome (ACS) with oral antiplatelets (OAPs) is recommended for
up to 12 months unless discontinuation is clinically indicated. Early discontinuation could
result in an increased risk of cardiovascular death or myocardial infarction due to the
patient's underlying disease.
There are no robust data allowing to evaluate the treatment persistence with OAPs after ACS
in the current practice in Belgium and Luxembourg at this time. It is currently unclear as
to why patients discontinue, switch or reinitiate treatment and upon whose advice. A
non-interventional study is needed to obtain reliable data on treatment persistence and
reasons for discontinuation, switch or reinitiation of treatment.
REWINDER is a multinational, multicentre, non-interventional, retrospective study of
patients treated with an oral antiplatelet (ticagrelor, prasugrel or clopidogrel) while in
hospital after an ACS event, to be conducted in Belgium and Luxembourg. Primary objective is
to evaluate the actual treatment persistence with OAPs after an ACS in the clinical practice
in Belgium and Luxembourg. The main secondary objectives are to describe the most frequent
reasons for OAP treatment switch, discontinuation or reinitiation; to identify the
decisionmakers in the OAP treatment changes and to characterize the patient profile in terms
of demographics, diagnosis, management strategies, comorbidities and concomitant medications
to identify any association between patient profile and treatment duration.
The target sample size of the study is 500 patients.
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Observational Model: Case-Only, Time Perspective: Retrospective