Protective Effect of Early High Dose stATins On Cardiovascular and Renal Events in Acute Coronary Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Coronary Syndrome. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Protective Effect of Early High Dose High-intensity Statins on Cardiovascular and Renal Events in Patients With Acute Coronary Syndrome
Overview
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.
Primary outcome measures
- Acute renal function changes [Time frame: Within 72 hours after hospital admission]
- Inflammatory profile changes [Time frame: up to 1 month]
- Lipid profile changes [Time frame: up to 1 month]
- Platelet count [Time frame: up to 1 month]
- Platelet volume [Time frame: up to 1 month]
- Platelet aggregation profile [Time frame: up to 1 month]
Secondary outcome measures (3)
- Major cardiovascular adverse events [Time frame: up to 12 months]
- Renal function changes [Time frame: Changes from baseline at 1 month]
- Major adverse cardiovascular and renal adverse events [Time frame: up to 1 month]
Eligibility criteria
Inclusion criteria
- Acute coronary syndrome (ST elevation and non ST elevation)
- Early invasive strategy
Exclusion criteria
- contraindication to statin therapy
- refusal of consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Cardiology Division, Prato Hospital — Prato
Identifiers
NCT: NCT04087200 · OSS 15.161