The Protective Effect of Early High Dose High-intensity Statins on Cardiovascular and Renal Events in Patients With Acute Coronary Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 2,500
- Locations
- 1
- Primary Endpoint
- Lipid profile changes
Study Overview
Brief Summary
Registration of all ACS patients (STEMI and NSTEMI) admitted to the cardiology ward and scheduled for early invasive strategy. The aim is to evaluate the protective effects of early (on admission) high-dose high-potency statin therapy on early and mid-term cardiac and renal events in this subset of patients.
Detailed Description
Statin-naive patients and those on statin therapy with ACS who are admitted to the cardiology ward of our public (National Health Service) hospital and are scheduled for early invasive strategy receive immediately on admission, always before angiographic procedure, high-dose statin therapy. Either atorvastatin 80 mg or rosuvastatin 40 mg is administered at the discretion of the physician. During hospitalization various pertinent cardiac and renal parameters, including hematological, angiographic, clinical data are registered in a dedicated database. Clinical follow-up and hematological analysis are done 1 month after discharge. A second follow-up, either clinical or by telephone, is done 1 year after discharge.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Acute coronary syndrome (ST elevation and non ST elevation)
- •Early invasive strategy
Exclusion Criteria
- •contraindication to statin therapy
- •refusal of consent
Outcomes
Primary Outcomes
Lipid profile changes
Time Frame: up to 1 month
Changes from baseline in cholesterol values
Platelet count
Time Frame: up to 1 month
Changes from baseline in platelet count
Platelet volume
Time Frame: up to 1 month
Changes from baseline in platelet volume
Platelet aggregation profile
Time Frame: up to 1 month
Changes from baseline in platelet reactivity (Verify Now)
Inflammatory profile changes
Time Frame: up to 1 month
Changes from baseline in CRP values
Acute renal function changes
Time Frame: Within 72 hours after hospital admission
Changes in creatinine and/or cystatine values
Secondary Outcomes
- Renal function changes(Changes from baseline at 1 month)
- Major cardiovascular adverse events(up to 12 months)
- Major adverse cardiovascular and renal adverse events(up to 1 month)
Investigators
Anna Toso
Principal Investigator
Centro Cardiopatici Toscani