Clinical trial NCT02190123: REalWorld Insights on the INitiation and Treatment Duration of ticagrEloR & Other Oral Antiplatelets (OAP) in Patients With Acute Coronary Syndrome (ACS) in Be/Lux.
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment of Acute Coronary Syndrome (ACS).
Keywords: Acute Coronary Syndrome (ACS)
Oral antiplatelets (ticagrelor, prasugrel, clopidogrel) (OAP)
Treatment persistence.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-07-15
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients from Belgium and Luxembourg, aged 18 years or more , discharged alive from hospital to home following an acute coronary syndrome (ACS) and who were treated with an oral antiplatelet (OAP) (ticagrelor, prasugrel or clopidogrel) after an acute coronary syndrome (ACS) event (Unstable Angina (UA), ST-elevation myocardial infarction (STEMI) or non-STEMI(NSTEMI)).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

The patient population that will be observed in the NIS must fulfil all of the following criteria:

1. Female or male aged ≥18 years
2. A patient information letter has been sent by the Investigator to the patient
3. Patient discharged alive from this hospital to home following ACS (diagnosed with STEMI, NSTEMI or UA)
4. ACS is either UA or myocardial infarction of Type 1 (spontaneous myocardial infarction related to ischemia due to a primary coronary event such as plaque erosion and/or rupture, fissuring, or dissection)
5. ACS after 1st July 2012 and before 1st June 2013
6. Patient on ticagrelor, prasugrel or clopidogrel treatment at discharge following an ACS

Exclusion Criteria:

Patients will not be eligible to participate if any of the following exclusion criteria are present:

1. Patient who participated in any interventional clinical study during the observation period.
2. Patient with ACS precipitated by or as complication of surgery, trauma, gastrointestinal bleeding or after Percutaneous Coronary Intervention (PCI)
3. Patient with ACS occurring during a stay in the hospital

Primary outcomes:
measure: The actual treatment persistence with OAP after an ACS in the clinical practice of Belgium and Luxembourg will be assessed by analysing the patient's 1-year follow data after discharge of an ACS event from hospital. Analysis will be descriptive.
timeFrame: up to 1 year
Secondary outcomes:
measure: The reasons for OAP treatment switch, discontinuation or re-initiation will be assessed by analysing the patient's 1-year follow data after discharge of an ACS event from hospital. Analysis will be descriptive.
timeFrame: up to 1 year
Other outcomes:
measure: The decisionmakers in the oral antiplatelet (OAP) treatment changes will be identified by analysing the patient's 1-year follow data after discharge of an ACS event from hospital. Analysis will be descriptive.
timeFrame: up to 1 year
measure: The patient profile will be characterized by analysing the patient's 1-year follow data after discharge of an ACS event from hospital. Analysis will be descriptive.
timeFrame: up to 1 year
Locations:
city: Aalst
country: Belgium
facility: Research Site
city: Baudour
country: Belgium
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Brasschaat
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Brussel
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Mechelen
country: Belgium
facility: Research Site
city: Montegnee
country: Belgium
facility: Research Site
city: Ronse
country: Belgium
facility: Research Site
city: Ukkel
country: Belgium
facility: Research Site
Study officials:
affiliation: Universitair Ziekenhuis Antwerpen (UZA)
name: Marc Claeys, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: