NCT01105325

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®);

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Geographic Reach
1 country

49 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

October 4, 2010

Status Verified

October 1, 2010

Enrollment Period

11 months

First QC Date

March 25, 2010

Last Update Submit

October 1, 2010

Conditions

Keywords

acute coronary syndrometreatment compliancecardiac intensive care unitsecondary preventioncardiac intensive care unit (CIC)complianceintensive care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (49)

Research Site

Antony, France

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Research Site

Argenteuil, France

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Arras, France

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Avignon, France

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Bayonne, France

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Boulogne-Billancourt, France

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Bourges, France

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Caen, France

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Cholet, France

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Clamart, France

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Colmar, France

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Creil, France

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Dijon, France

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Eaubonne, France

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Épernay, France

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La Rochelle, France

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La Tronche, France

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Le Chesnay, France

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Le Coudray, France

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Le Plessis-Robinson, France

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Lens, France

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Libourne, France

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Lomme, France

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Lorient, France

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Lyon, France

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Mantes-la-Jolie, France

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Marseille, France

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Metz, France

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Montfermeil, France

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Neuilly-sur-Seine, France

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Nevers, France

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Niort, France

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Orléans, France

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Paris, France

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Pau, France

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Perpignan, France

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Pessac, France

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Périgueux, France

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Reims, France

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Rodez, France

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Saint-Nazaire, France

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Salouël, France

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Schiltigheim, France

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Strasbourg, France

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Toulouse, France

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Troyes, France

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Valence, France

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Vandœuvre-lès-Nancy, France

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Villeneuve-Saint-Georges, France

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MeSH Terms

Conditions

Acute Coronary SyndromePatient Compliance

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Pascal Piedbois

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 25, 2010

First Posted

April 16, 2010

Study Start

April 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

October 4, 2010

Record last verified: 2010-10

Locations