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

Terminated

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT01105325
• Lead Sponsor: AstraZeneca

Brief Summary

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®);

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-25
• Study Start: 2010-04
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-16
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-01
• Last Update Posted: 2010-10-04
• Primary Completion: 2011-03
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	3 months / every day

Secondary Outcome Measures

Name	Time	Method
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®").	1 and 2 months / every day
Describe global compliance with the entire prescription over 6 months	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®).	6 months

Trial Locations

Locations (1)

Research Site; 🇫🇷 Villeneuve St Georges Cedex, France