Treatment of Acute Coronary Syndrome (ACS).REWINDERNCT02190123
REalWorld Insights on the INitiation and Treatment Duration of ticagrEloR & Other Oral Antiplatelets (OAP) in Patients With Acute Coronary Syndrome (ACS) in Be/Lux.
An observational study of Treatment of Acute Coronary Syndrome (ACS)., run by AstraZeneca at 15 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Treatment of Acute Coronary Syndrome (ACS).
- What is being tested?
- ACS patients treated with OAP
- Type of treatment
- Pill or oral medicine
- How many people
- 430 participants
- Where
- 15 sitesBelgium
- Study dates
- Sep 2014to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)).
Who may be able to join
- The patient population that will be observed in the NIS must fulfil all of the following criteria:
- Female or male aged ≥18 years
- A patient information letter has been sent by the Investigator to the patient
- Patient discharged alive from this hospital to home following ACS (diagnosed with STEMI, NSTEMI or UA)
- 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)
- ACS after 1st July 2012 and before 1st June 2013
- Patient on ticagrelor, prasugrel or clopidogrel treatment at discharge following an ACS
Who cannot join
- Patients will not be eligible to participate if any of the following exclusion criteria are present:
- Patient who participated in any interventional clinical study during the observation period.
- Patient with ACS precipitated by or as complication of surgery, trauma, gastrointestinal bleeding or after Percutaneous Coronary Intervention (PCI)
- Patient with ACS occurring during a stay in the hospital
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Belgium15 sites
Research Site
Aalst
Research Site
Baudour
Research Site
Bonheiden
Research Site
Brasschaat
Research Site
Bruges
Research Site
Brussels
Research Site
Charleroi
Research Site
Edegem
Research Site
Ghent
Research Site
Leuven
Research Site
Liège
Research Site
Mechelen
Research Site
Montegnée
Research Site
Ronse
Research Site
Uccle
About this study
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)
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.
Read the 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.
- Being tested
- ACS patients treated with OAP
- Keywords
- Acute Coronary Syndrome (ACS), Oral antiplatelets (ticagrelor, prasugrel, clopidogrel) (OAP), Treatment persistence.
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACS patients treated with OAPDrug
Patients with ACS who have been initiated and treated with ticagrelor and other oral antiplatelets.
| Study group | Role | What they receive |
|---|---|---|
| ACS patients treated with OAP | Patients with ACS who have been initiated and treated with ticagrelor and other oral antiplatelets Receives: Drug: ACS patients treated with OAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 year
Secondary outcomes (1)
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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Acute Coronary Syndrome (ACS).Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Claeys, Prof Dr, Principal investigator, Universitair Ziekenhuis Antwerpen (UZA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190123
- Sponsor's protocol ID
- NIS-CBE-XXX-2014/1
- Acronym
- REWINDER
- Status last verified
- Jan 2016
- First submitted
- 11 Jul 2014
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02190123
- Acronym / sponsor ID
- REWINDER / NIS-CBE-XXX-2014/1
- Keywords
- Acute Coronary Syndrome (ACS), Oral antiplatelets (ticagrelor, prasugrel, clopidogrel) (OAP), Treatment persistence.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACS patients treated with OAP | – | Drug: ACS patients treated with OAPPatients with ACS who have been initiated and treated with ticagrelor and other oral antiplatelets |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)).
Key inclusion criteria (7 listed)
- The patient population that will be observed in the NIS must fulfil all of the following criteria:
- Female or male aged ≥18 years
- A patient information letter has been sent by the Investigator to the patient
- Patient discharged alive from this hospital to home following ACS (diagnosed with STEMI, NSTEMI or UA)
- 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)
Key exclusion criteria (4 listed)
- Patients will not be eligible to participate if any of the following exclusion criteria are present:
- Patient who participated in any interventional clinical study during the observation period.
- Patient with ACS precipitated by or as complication of surgery, trauma, gastrointestinal bleeding or after Percutaneous Coronary Intervention (PCI)
- Patient with ACS occurring during a stay in the hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACS patients treated with OAPPatients with ACS who have been initiated and treated with ticagrelor and other oral antiplatelets. | Drug | ACS patients treated with OAP |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- SynopsisLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Claeys, Prof Dr principal investigator
Universitair Ziekenhuis Antwerpen (UZA)
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment of Acute Coronary Syndrome (ACS)., run by AstraZeneca at 15 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.