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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00465322 |
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Date of registration:
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23/04/2007 |
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Primary sponsor: |
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Public title:
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Effect of Fluvastatin on Top of Clopidogrel and Aspirin in Patients After DES Implantation on Platelet Aggregation
EFA-1 |
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Scientific title:
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Effect of Fluvastatin on Top of Clopidogrel and Aspirin in Patients After DES Implantation on Platelet Aggregation |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00465322 |
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Study type:
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Observational |
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Study design:
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Additional Descriptors: Convenience Sample, Time Perspective: Longitudinal, Time Perspective: Prospective
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Otto M Hess, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cardiology University Hospital Bern |
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Name:
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Peter Wenaweser, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cardiology University Hospital Bern |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- all patients with stent implantation followed by treatment with aspirin and
clopidogrel
- routinely treated with acetylsalicylic 100 mg/day
Exclusion Criteria:
- acute coronary syndrome
- use of a GPIIb/IIIa inhibitor
- allergy to acetylsalicylic acid, clopidogrel, statins
- elevated liver enzymes (> 3 x norm value)
- muscle myopathy
- active liver disease
- recent gastrointestinal bleeding (< 3 months)
- known platelet dysfunction or abnormal platelet count
- pregnancy
- indication for treatment with non-steroidal drugs
- indication for long-term treatment with a drug metabolized by cytochrome p450 3A4 or
2C9
Age minimum:
18 Years
Age maximum:
95 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Drug-Interactions
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Intervention(s)
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Drug: fluvastatin
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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