Treatment of Acute Coronary Syndrome (ACS). Clinical Trial
— REWINDEROfficial 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.
| Status | Completed |
| Enrollment | 430 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 130 Years |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Research Site | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | No |
| Other | 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 | No |
| Primary | 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 | No |
| Secondary | 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 | No |