REalWorld Insights on the INitiation and Treatment Duration of ticagrEloR & Other Oral Antiplatelets (OAP) in Patients With Acute Coronary Syndrome (ACS) in Be/Lux. (REWINDER)

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.

Study Overview

• Status: Completed
• Conditions: Treatment of Acute Coronary Syndrome (ACS).
• Intervention / Treatment: Drug: ACS patients treated with OAP

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.

• Study Type: Observational
• Enrollment (Actual): 430

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • Research Site
  • Baudour, Belgium
    • Research Site
  • Bonheiden, Belgium
    • Research Site
  • Brasschaat, Belgium
    • Research Site
  • Brugge, Belgium
    • Research Site
  • Brussel, Belgium
    • Research Site
  • Bruxelles, Belgium
    • Research Site
  • Charleroi, Belgium
    • Research Site
  • Edegem, Belgium
    • Research Site
  • Gent, Belgium
    • Research Site
  • Leuven, Belgium
    • Research Site
  • Liege, Belgium
    • Research Site
  • Mechelen, Belgium
    • Research Site
  • Montegnee, Belgium
    • Research Site
  • Ronse, Belgium
    • Research Site
  • Ukkel, Belgium
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Patients discharged after an ACS event and fulfilling the entry criteria will be included in each centre. The retrospective observation period will be 1 year, starting on the date of discharge to home. Data on OAD treatment situation during the observation period will be collected. Number and proportion of patients having stopped treatment after 1, 3, 6, 9 & 12 month will be assessed and described.	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Patients discharged after an ACS event and fulfilling the entry criteria will be included in each centre. The retrospective observation period will be 1 year, starting on the date of discharge to home. Data on OAD treatment situation during the observation period will be collected. The reasons for switch, discontinuation & re-initiation (side-effects, drug-drug interactions, cost of treatment, patient's complaint, high bleeding risk & other) will be assessed and described.	up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Patients discharged after an ACS event and fulfilling the entry criteria will be included in each centre. The retrospective observation period will be 1 year, starting on the date of discharge to home. Data on OAD treatment situation during the observation period will be collected. The decisionmakers will be identified and described (cardiologist interventional, cardiologist non interventional, surgeon, other specialist, dentist, GP, patient and/or family, other).	up to 1 year
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.	Patients discharged after an ACS event and fulfilling the entry criteria will be included in each centre. The retrospective observation period will be 1 year, starting on the date of discharge to home. Data on OAD treatment situation during the observation period will be collected. Patient profile will be described in terms of demographics, diagnosis, management strategies, comorbidities and concomitant medications to identify any association between patient profile and treatment duration.	up to 1 year

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Marc Claeys, Prof Dr, Universitair Ziekenhuis Antwerpen (UZA)

Publications and helpful links

Helpful Links

• Synopsis

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Estimate): January 8, 2016
• Last Update Submitted That Met QC Criteria: January 7, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Acute Coronary Syndrome (ACS); Oral antiplatelets (ticagrelor, prasugrel, clopidogrel) (OAP); Treatment persistence.
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: NIS-CBE-XXX-2014/1