Coronary Disease, Myocardial Infarction
Conditions
Keywords
Coronary disease, Myocardial infarction, Statins
Brief summary
This study is to evaluate the safety and efficacy of fluvastatin versus placebo, dosed shortly after or immediately when the coronary event occurs.
Interventions
DRUGFluvastatin
Sponsors
Ministry of Health, Czech Republic
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Acute coronary syndrome * Adults, 18 years and older
Exclusion criteria
* History of lipid lowering therapy less than 30 days before index event * Pregnancy and nursing * Subject younger than 18 years Other inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in circulating markers of inflammation after 4 weeks and after 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of death, nonfatal myocardial infarction, cardiac arrest with resuscitation, recurrent symptomatic ischemia, and urgent revascularization after 4 weeks and after 52 weeks | — |
Countries
Czechia
Outcome results
None listed