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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:
ClinicalTrials.gov Identifier:
NCT01105325
First Posted: April 16, 2010
Last Update Posted: October 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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

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 ]

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 ]
  • Describe global compliance with the entire prescription over 6 months [ Time Frame: 6 months / Once at 6 months follow-up ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105325


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

Responsible Party: MCMD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01105325     History of Changes
Other Study ID Numbers: NIS-CFR-CRE-2010/1
First Submitted: March 25, 2010
First Posted: April 16, 2010
Last Update Posted: October 4, 2010
Last Verified: October 2010

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:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases