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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 January 2016 |
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Main ID: |
NCT02190123 |
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Date of registration:
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11/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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 |
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Scientific title:
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REalWorld Insights on the INitiation and Treatment Duration of ticagrEloR & Other Oral Antiplatelets in Patients With Acute Coronary Syndrome in Belgium/Luxembourg (REWINDER) |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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430 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02190123 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Retrospective
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Marc Claeys, Prof Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitair Ziekenhuis Antwerpen (UZA) |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
130 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Treatment of Acute Coronary Syndrome (ACS).
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Intervention(s)
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Drug: ACS patients treated with OAP
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Primary Outcome(s)
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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.
[Time Frame: up to 1 year]
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Secondary Outcome(s)
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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.
[Time Frame: up to 1 year]
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Secondary ID(s)
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NIS-CBE-XXX-2014/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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