Heart Failure
Conditions
Brief summary
The purpose of the study is to investigate if rosuvastatin, added on top of all other medicines prescribed to subjects with symptomatic systolic heart failure, reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke (time to first event)
Interventions
DRUGCRESTOR
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic symptomatic systolic heart failure of ischaemic aetiology as judged by the investigator, optimal therapy for chronic symptomatic systolic heart failure according to the investigator
Exclusion criteria
* Acute myocardial infarction within 6 months before randomization * Treatment with any statin or other lipid lowering drug; or a medical condition that in the opinion of the investigator requires treatment with a statin or other lipid lowering drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine whether rosuvastatin reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction (MI) or non-fatal stroke (time to first event). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to evaluate the effects of rosuvastatin on: | — |
| Total mortality | — |
| Any coronary event defined as the combined endpoint of sudden death or fatal or non-fatal MI or Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Grafting (CABG) or defibrillation of ventricular fibrillation by an implant | — |
| Cardiovascular mortality with cause-specific mortality for sudden death; fatal MI; and death from worsening heart failure | — |
| Total number of hospitalizations for cardiovascular causes; for unstable angina; and for worsening heart failure | — |
Countries
Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed