Ignite Creation Date:
2024-05-06 @ 3:04 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02190123
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2014-07-11
Brief Title:
REalWorld Insights on the INitiation and Treatment Duration of ticagrEloR Other Oral Antiplatelets OAP in Patients With Acute Coronary Syndrome ACS in BeLux
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
REalWorld Insights on the INitiation and Treatment Duration of ticagrEloR Other Oral Antiplatelets in Patients With Acute Coronary Syndrome in BelgiumLuxembourg REWINDER
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REWINDER
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
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 patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None