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

This study has been terminated.
(due to poor patient recruitment)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01105325
First received: March 25, 2010
Last updated: October 1, 2010
Last verified: October 2010
History of Changes
  Purpose

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
Acute Coronary Syndrome

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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. [ Time Frame: 3 months / every day ] [ Designated as safety issue: No ]

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®"). [ Time Frame: 1 and 2 months / every day ] [ Designated as safety issue: No ]
  • Describe global compliance with the entire prescription over 6 months [ Time Frame: 6 months / Once at 6 months follow-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: April 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105325

  Show 49 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Pascal Piedbois AstraZeneca
  More Information

No publications provided

Responsible Party: MCMD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01105325     History of Changes
Other Study ID Numbers: NIS-CFR-CRE-2010/1
Study First Received: March 25, 2010
Last Updated: October 1, 2010
Health Authority: France: French Data Protection Authority
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by AstraZeneca:
acute coronary syndrome
treatment compliance
cardiac intensive care unit
secondary prevention
 cardiac intensive care unit (CIC)
compliance
intensive care

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 13, 2013