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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02190123
First received: July 11, 2014
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Treatment of Acute Coronary Syndrome (ACS).
Drug: ACS patients treated with OAP

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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. [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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).

  • 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. [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 500
Study Start Date: September 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02190123

Contacts
Contact: Marleen Schepens ClinicalTrialTransparency@astrazeneca.com
Contact: Veronique Deschamp ClinicalTrialTransparency@astrazeneca.com

Locations
Belgium
OLV-ziekenhuis Not yet recruiting
Aalst, Belgium, 9300
Contact: Carlos Van Mieghem, Dr         
Universitair Ziekenhuis Antwerpen Recruiting
Antwerpen, Belgium, 2610
Contact: Marc Claeys, Prof         
Principal Investigator: Marc Claeys, Prof Dr         
Imeldaziekenhuis Not yet recruiting
Bonheiden, Belgium, 2820
Contact: Luc Janssens, Dr         
AZ Klina Not yet recruiting
Brasschaat, Belgium, 2930
Contact: Frank Cools, Dr         
AZ Sint-Jan Recruiting
Brugge, Belgium, 8000
Contact: Luc Missault, Dr         
UZ Brussel Not yet recruiting
Brussel, Belgium, 1090
Contact: Jeroen Sonck, Dr         
Erasme Not yet recruiting
Bruxelles, Belgium, 1070
Contact: Nicolas Preumont, Dr         
CHU St-Pierre Not yet recruiting
Bruxelles, Belgium, 1000
Contact: Paul-Gaël Silance, Dr         
Clin. Univ. St-Luc Not yet recruiting
Bruxelles, Belgium, 1200
Contact: Christophe Beauloye, Prof         
GHDC Not yet recruiting
Charleroi, Belgium, 6000
Contact: Yves Dascotte, Dr         
AZ Sint-Lucas Not yet recruiting
Gent, Belgium, 9000
Contact: Jan Nimmegeers, Dr         
UZ Gent Not yet recruiting
Gent, Belgium, 9000
Contact: Sofie Gevaert, Dr         
UZ Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Peter Sinnaeve, Prof         
CHR de la Citadelle Not yet recruiting
Liège, Belgium, 4000
Contact: Suzanne Pourbaix, Dr         
Clinique de l'Espérance Not yet recruiting
Montagnée, Belgium, 4420
Contact: Lucien Finianos, Dr         
AZ Glorieux Not yet recruiting
Ronse, Belgium, 9600
Contact: Alex Heyse, Dr         
AZ Nikolaas Not yet recruiting
Sint-Niklaas, Belgium, 9100
Contact: Joeri Voet, Dr         
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Marc Claeys, Prof Dr Universitair Ziekenhuis Antwerpen (UZA)
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02190123     History of Changes
Other Study ID Numbers: NIS-CBE-XXX-2014/1
Study First Received: July 11, 2014
Last Updated: September 17, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by AstraZeneca:
Acute Coronary Syndrome (ACS)
Oral antiplatelets (ticagrelor, prasugrel, clopidogrel) (OAP)
Treatment persistence.

Additional relevant MeSH terms:
Myocardial Ischemia
Acute Coronary Syndrome
Syndrome
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014