Study identifier:NIS-CBE-XXX-2014/1
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
REalWorld insights on the INitiation and treatment Duration of ticagrEloR & other oral antiplatelets in patients with acute coronary syndrome in Belgium/Luxembourg (REWINDER)
Treatment of Acute Coronary Syndrome (ACS).
N/A
No
ACS patients treated with OAP
All
430
Observational
18 Years - 150 Years
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Jan 2016 by AstraZeneca
AstraZeneca
-
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.
Location
Location
Edegem, Belgium
Location
Leuven, Belgium
Location
Liege, Belgium
Location
Aalst, Belgium
Location
Montegnee, Belgium
Location
Bruxelles, Belgium
Location
Brugge, Belgium
Location
Brasschaat, Belgium
Arms | Assigned Interventions |
---|---|
ACS patients treated with OAP Patients with ACS who have been initiated and treated with ticagrelor and other oral antiplatelets | Drug: ACS patients treated with OAP Patients with ACS who have been initiated and treated with ticagrelor and other oral antiplatelets. |
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