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

Acute Coronary Syndrome Clinical Trial

— SCAVANCE  

Official title:

Evaluation of Compliance With Management of Acute Coronary Syndrome on Discharge From Cardiac Intensive Care (CIC) - Electronic Measurement of Compliance

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01105325
• Other study ID #: NIS-CFR-CRE-2010/1
• Status: Terminated
• Phase: N/A
• First received: March 25, 2010
• Last updated: October 1, 2010
• Start date: April 2010
• Est. completion date: March 2011

Study information

• Verified date: October 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection AuthorityFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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®);

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1000
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
France	Research Site	Antony Cedex
France	Research Site	Argenteuil Cedex
France	Research Site	Arras
France	Research Site	Avignon Cedex 9
France	Research Site	Bayonne Cedex
France	Research Site	Boulogne Billancourt Cedex
France	Research Site	Bourges Cedex
France	Research Site	Caen Cedex 9
France	Research Site	Cholet
France	Research Site	Clamart Cedex
France	Research Site	Colmar Cedex
France	Research Site	Creil
France	Research Site	Dijon Cedex
France	Research Site	Eaubonne Cedex
France	Research Site	Epernay
France	Research Site	La Rochelle
France	Research Site	La Tronche
France	Research Site	Le Chesnay
France	Research Site	Le Coudray
France	Research Site	Le Plessis Robinson
France	Research Site	Lens Cedex
France	Research Site	Libourne
France	Research Site	Lomme Cedex
France	Research Site	Lorient Cedex
France	Research Site	Lyon Cedex 03
France	Research Site	Mantes La Jolie Cedex
France	Research Site	Marseille
France	Research Site	Metz
France	Research Site	Montfermeil
France	Research Site	Neuilly Sur Seine Cedex
France	Research Site	Nevers Cedex
France	Research Site	Niort Cedex
France	Research Site	Orleans
France	Research Site	Paris
France	Research Site	Pau Cedex
France	Research Site	Perigueux Cedex
France	Research Site	Perpignan
France	Research Site	Pessac Cedex
France	Research Site	Reims Cedex
France	Research Site	Rodez Cedex 9
France	Research Site	Salouel
France	Research Site	Schiltigheim Cedex
France	Research Site	St Nazaire Cedex
France	Research Site	Strasbourg Cedex
France	Research Site	Toulouse Cedex 9
France	Research Site	Troyes Cedex
France	Research Site	Valence Cedex 9
France	Research Site	Vandoeuvre Les Nancy Cedex
France	Research Site	Villeneuve St Georges Cedex

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Describe global compliance with the entire prescription over 6 months		6 months / Once at 6 months follow-up	No
Secondary	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	No