Acute Coronary SyndromeSCAVANCENCT01105325
Evaluation of Compliance With Management of Acute Coronary Syndrome on Discharge From Cardiac Intensive Care
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 49 sites in France.
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 … Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 1,000 participants
- Where
- 49 sitesFrance
- Study dates
- Apr 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
France49 sites
Research Site
Antony
Research Site
Argenteuil
Research Site
Arras
Research Site
Avignon
Research Site
Bayonne
Research Site
Boulogne-Billancourt
Research Site
Bourges
Research Site
Caen
Research Site
Cholet
Research Site
Clamart
Research Site
Colmar
Research Site
Creil
Research Site
Dijon
Research Site
Eaubonne
Research Site
Épernay
Research Site
La Rochelle
Research Site
La Tronche
Research Site
Le Chesnay
Research Site
Le Coudray
Research Site
Le Plessis-Robinson
Research Site
Lens
Research Site
Libourne
Research Site
Lomme
Research Site
Lorient
Research Site
Lyon
Research Site
Mantes-la-Jolie
Research Site
Marseille
Research Site
Metz
Research Site
Montfermeil
Research Site
Neuilly-sur-Seine
Research Site
Nevers
Research Site
Niort
Research Site
Orléans
Research Site
Paris
Research Site
Pau
Research Site
Périgueux
Research Site
Perpignan
Research Site
Pessac
Research Site
Reims
Research Site
Rodez
Research Site
Saint-Nazaire
Research Site
Salouël
Research Site
Schiltigheim
Research Site
Strasbourg
Research Site
Toulouse
Research Site
Troyes
Research Site
Valence
Research Site
Vandœuvre-lès-Nancy
Research Site
Villeneuve-Saint-Georges
About this study
Official title: 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®);
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, treatment compliance, cardiac intensive care unit, secondary prevention, cardiac intensive care unit (CIC), compliance, intensive care
- Medical subject headings
- Acute Coronary Syndrome, Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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®").
Measured: 1 and 2 months / every day
Describe global compliance with the entire prescription over 6 months
Measured: 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®).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Why it stopped: due to poor patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pascal Piedbois, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105325
- Sponsor's protocol ID
- NIS-CFR-CRE-2010/1
- Acronym
- SCAVANCE
- Status last verified
- Oct 2010
- First submitted
- 25 Mar 2010
- Last updated
- 4 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Compliance With Management of Acute Coronary Syndrome on Discharge From Cardiac Intensive Care (CIC) - Electronic Measurement of Compliance
- ClinicalTrials.gov ID
- NCT01105325
- Acronym / sponsor ID
- SCAVANCE / NIS-CFR-CRE-2010/1
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, treatment compliance, cardiac intensive care unit, secondary prevention, cardiac intensive care unit (CIC), compliance, intensive care
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to poor patient recruitment
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 16 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcomes
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
Describe global compliance with the entire prescription over 6 months
Time frame: 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
Results and safety
The study was stopped early (reason given: due to poor patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Piedbois study director
AstraZeneca
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 49 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to poor patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2010.