Clinical trial NCT01105325: Evaluation of Compliance With Management of Acute Coronary Syndrome on Discharge From Cardiac Intensive Care
Official title: Evaluation of Compliance With Management of Acute Coronary Syndrome on Discharge From Cardiac Intensive Care (CIC) - Electronic Measurement of Compliance
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Coronary Syndrome
Keywords: acute coronary syndrome
treatment compliance
cardiac intensive care unit
secondary prevention
cardiac intensive care unit (CIC)
compliance
intensive care
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-04-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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®);


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 3 months / every day
Secondary outcomes:
measure: 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®").
timeFrame: 1 and 2 months / every day
measure: Describe global compliance with the entire prescription over 6 months
timeFrame: 6 months / Once at 6 months follow-up
measure: 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®).
timeFrame: 6 months
Other outcomes:
Locations:
city: Antony Cedex
country: France
facility: Research Site
city: Argenteuil Cedex
country: France
facility: Research Site
city: Arras
country: France
facility: Research Site
city: Avignon Cedex 9
country: France
facility: Research Site
city: Bayonne Cedex
country: France
facility: Research Site
city: Boulogne Billancourt Cedex
country: France
facility: Research Site
city: Bourges Cedex
country: France
facility: Research Site
city: Caen Cedex 9
country: France
facility: Research Site
city: Cholet
country: France
facility: Research Site
city: Clamart Cedex
country: France
facility: Research Site
city: Colmar Cedex
country: France
facility: Research Site
city: Creil
country: France
facility: Research Site
city: Dijon Cedex
country: France
facility: Research Site
city: Eaubonne Cedex
country: France
facility: Research Site
city: Epernay
country: France
facility: Research Site
city: La Rochelle
country: France
facility: Research Site
city: La Tronche
country: France
facility: Research Site
city: Le Chesnay
country: France
facility: Research Site
city: Le Coudray
country: France
facility: Research Site
city: Le Plessis Robinson
country: France
facility: Research Site
city: Lens Cedex
country: France
facility: Research Site
city: Libourne
country: France
facility: Research Site
city: Lomme Cedex
country: France
facility: Research Site
city: Lorient Cedex
country: France
facility: Research Site
city: Lyon Cedex 03
country: France
facility: Research Site
city: Mantes La Jolie Cedex
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Metz
country: France
facility: Research Site
city: Montfermeil
country: France
facility: Research Site
city: Neuilly Sur Seine Cedex
country: France
facility: Research Site
city: Nevers Cedex
country: France
facility: Research Site
city: Niort Cedex
country: France
facility: Research Site
city: Orleans
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Pau Cedex
country: France
facility: Research Site
city: Perigueux Cedex
country: France
facility: Research Site
city: Perpignan
country: France
facility: Research Site
city: Pessac Cedex
country: France
facility: Research Site
city: Reims Cedex
country: France
facility: Research Site
city: Rodez Cedex 9
country: France
facility: Research Site
city: Salouel
country: France
facility: Research Site
city: Schiltigheim Cedex
country: France
facility: Research Site
city: St Nazaire Cedex
country: France
facility: Research Site
city: Strasbourg Cedex
country: France
facility: Research Site
city: Toulouse Cedex 9
country: France
facility: Research Site
city: Troyes Cedex
country: France
facility: Research Site
city: Valence Cedex 9
country: France
facility: Research Site
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Research Site
city: Villeneuve St Georges Cedex
country: France
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Pascal Piedbois
role: STUDY_DIRECTOR
References: