Evaluation of Compliance With Management of Acute Coronary Syndrome on Discharge From Cardiac Intensive Care (SCAVANCE)

This study has been terminated.
(due to poor patient recruitment)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01105325
First received: March 25, 2010
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

To study compliance with secondary prevention during the first months following discharge from the cardiac intensive care unit (CIC) of patients experiencing a first episode of acute coronary syndrome : quantitative compliance over 3 months with the two principal treatments of the prescription (a statin - rosuvastatin, Crestor® and a platelet aggregation inhibitor - clopidogrel, Plavix®), using an electronic measure system ("intelligent blister" pack®);


Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Compliance With Management of Acute Coronary Syndrome on Discharge From Cardiac Intensive Care (CIC) - Electronic Measurement of Compliance

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To measure, using an electronic system ("intelligent blister pack®"), the duration of treatment and number of treatment intake per day over 3 months with statin and oral antiplatelet therapy following an inaugural acute coronary syndrome. [ Time Frame: 3 months / every day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of the duration of treatment and number of treatment intake per day at 1 month and 2 months with a statin and a platelet aggregation inhibitor, using an electronic system ("intelligent blister pack®"). [ Time Frame: 1 and 2 months / every day ] [ Designated as safety issue: No ]
  • Describe global compliance with the entire prescription over 6 months [ Time Frame: 6 months / Once at 6 months follow-up ] [ Designated as safety issue: No ]
  • Determine the factors influencing compliance with treatment on discharge from CIC (discharge treatment including a statin - rosuvastatin, Crestor® and a platelet aggregation inhibitor - clopidogrel, Plavix®). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: April 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

First 10 patients admitted to the CIC unit for a first episode of acute coronary syndrome, in whom the CIC cardiologist considers that Crestor® - rosuvastatin is the most appropriate statin for management in hospital, in combination with a platelet aggregation inhibitor (Plavix® - clopidogrel).

Criteria

Inclusion Criteria:

  • Patient admitted to the CIC unit for a first episode of acute coronary syndrome, in whom the CIC cardiologist considers that Crestor® -rosuvastatin is the most appropriate statin, in combination with a platelet aggregation inhibitor (Plavix®-clopidogrel)
  • Patient giving his/her oral consent to participate in the study.
  • Patient not previously treated by a lipid-lowering drug.

Exclusion Criteria:

  • Patient with a known history of coronary heart disease.
  • Patient whose treatment on discharge comprises only one of the two study treatments
  • Patient participating or who has participated in the previous 3 months in a biomedical research study in cardiology.
  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: NCT01105325

  Show 49 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Pascal Piedbois AstraZeneca
  More Information

No publications provided

Responsible Party: MCMD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01105325     History of Changes
Other Study ID Numbers: NIS-CFR-CRE-2010/1
Study First Received: March 25, 2010
Last Updated: October 1, 2010
Health Authority: France: French Data Protection Authority
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by AstraZeneca:
acute coronary syndrome
treatment compliance
cardiac intensive care unit
secondary prevention
cardiac intensive care unit (CIC)
compliance
intensive care

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014