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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01105325 |
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Date of registration:
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25/03/2010 |
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Primary sponsor: |
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Public title:
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Evaluation of Compliance With Management of Acute Coronary Syndrome on Discharge From Cardiac Intensive Care
SCAVANCE |
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Scientific title:
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Evaluation of Compliance With Management of Acute Coronary Syndrome on Discharge From Cardiac Intensive Care (CIC) - Electronic Measurement of Compliance |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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1000 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01105325 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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France
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Contacts
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Name:
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Pascal Piedbois |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Coronary Syndrome
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Describe global compliance with the entire prescription over 6 months
[Time Frame: 6 months / Once at 6 months follow-up]
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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]
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Secondary ID(s)
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NIS-CFR-CRE-2010/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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