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

Sponsor

AstraZeneca (Industry)

Overall Status

Terminated

CT.gov ID

NCT01105325

Collaborator

(none)

1,000

Enrollment

Locations

Duration (Months)

20.4

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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®);

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

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

Study Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

Mar 1, 2011

Anticipated Study Completion Date :

Mar 1, 2011

Outcome Measures

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. [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®"). [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Research Site	Antony Cedex	France
2	Research Site	Argenteuil Cedex	France
3	Research Site	Arras	France
4	Research Site	Avignon Cedex 9	France
5	Research Site	Bayonne Cedex	France
6	Research Site	Boulogne Billancourt Cedex	France
7	Research Site	Bourges Cedex	France
8	Research Site	Caen Cedex 9	France
9	Research Site	Cholet	France
10	Research Site	Clamart Cedex	France
11	Research Site	Colmar Cedex	France
12	Research Site	Creil	France
13	Research Site	Dijon Cedex	France
14	Research Site	Eaubonne Cedex	France
15	Research Site	Epernay	France
16	Research Site	La Rochelle	France
17	Research Site	La Tronche	France
18	Research Site	Le Chesnay	France
19	Research Site	Le Coudray	France
20	Research Site	Le Plessis Robinson	France
21	Research Site	Lens Cedex	France
22	Research Site	Libourne	France
23	Research Site	Lomme Cedex	France
24	Research Site	Lorient Cedex	France
25	Research Site	Lyon Cedex 03	France
26	Research Site	Mantes La Jolie Cedex	France
27	Research Site	Marseille	France
28	Research Site	Metz	France
29	Research Site	Montfermeil	France
30	Research Site	Neuilly Sur Seine Cedex	France
31	Research Site	Nevers Cedex	France
32	Research Site	Niort Cedex	France
33	Research Site	Orleans	France
34	Research Site	Paris	France
35	Research Site	Pau Cedex	France
36	Research Site	Perigueux Cedex	France
37	Research Site	Perpignan	France
38	Research Site	Pessac Cedex	France
39	Research Site	Reims Cedex	France
40	Research Site	Rodez Cedex 9	France
41	Research Site	Salouel	France
42	Research Site	Schiltigheim Cedex	France
43	Research Site	St Nazaire Cedex	France
44	Research Site	Strasbourg Cedex	France
45	Research Site	Toulouse Cedex 9	France
46	Research Site	Troyes Cedex	France
47	Research Site	Valence Cedex 9	France
48	Research Site	Vandoeuvre Les Nancy Cedex	France
49	Research Site	Villeneuve St Georges Cedex	France