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

October 1, 2010 updated by: AstraZeneca

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

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®);

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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, France
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 3 months / every day
3 months / every day

Secondary Outcome Measures

Outcome Measure
Time Frame
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®").
Time Frame: 1 and 2 months / every day
1 and 2 months / every day
Describe global compliance with the entire prescription over 6 months
Time Frame: 6 months / Once at 6 months follow-up
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®).
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

March 1, 2011

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

March 25, 2010

First Submitted That Met QC Criteria

April 15, 2010

First Posted (Estimate)

April 16, 2010

Study Record Updates

Last Update Posted (Estimate)

October 4, 2010

Last Update Submitted That Met QC Criteria

October 1, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CFR-CRE-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe