Protective Effect of Early High Dose stATins On Cardiovascular and Renal Events in Acute Coronary Syndrome (PRATO-ACS)

The Protective Effect of Early High Dose High-intensity Statins on Cardiovascular and Renal Events in Patients With Acute Coronary Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome

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 Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: Anna Toso, MD; Phone Number: 00393387982507; Email: anna.toso@libero.it
• Study Contact Backup: Name: Mario Leoncini, MD; Phone Number: 0039-0574803738; Email: leoncini.mario@tiscali.it

Study Locations

• Italy
  • Prato, Italy, 59100
    • Recruiting
    • Cardiology Division, Prato Hospital
    • Contact: Anna Toso, MD; Phone Number: +390574434396; Email: anna.toso@libero.it
    • Contact: Mario Leoncini, MD; Phone Number: +390574434270; Email: leoncini.mario@tiscali.it
    • Sub-Investigator: Francesco Bellandi, MD
    • Sub-Investigator: Francesco Tropeano, MD
    • Sub-Investigator: Mauro Maioli, MD
    • Sub-Investigator: Nicola Musilli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Statin-naive patients and those on statin therapy with ACS (both STEMI and NSTEMI)

Description

Inclusion Criteria:

• Acute coronary syndrome (ST elevation and non ST elevation)
• Early invasive strategy

Exclusion Criteria:

• contraindication to statin therapy
• refusal of consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute renal function changes	Changes in creatinine and/or cystatine values	Within 72 hours after hospital admission
Inflammatory profile changes	Changes from baseline in CRP values	up to 1 month
Lipid profile changes	Changes from baseline in cholesterol values	up to 1 month
Platelet count	Changes from baseline in platelet count	up to 1 month
Platelet volume	Changes from baseline in platelet volume	up to 1 month
Platelet aggregation profile	Changes from baseline in platelet reactivity (Verify Now)	up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major cardiovascular adverse events	Death, myocardial infarction, stroke or coronary revascularization	up to 12 months
Renal function changes	glomerular filtration rate	Changes from baseline at 1 month
Major adverse cardiovascular and renal adverse events	Death, myocardial infarction, stroke, coronary revascularization or glomerular filtration rate reduction > = 25% compared to baseline	up to 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of age and frailty profile on primary and secondary outcomes	Frailty evaluation (combination of FRAIL scale questionnaire and hand-grip strength measurement)	Up to 1 month

Collaborators and Investigators

• Sponsor: Centro Cardiopatici Toscani
• Collaborators: Azienda USL 4 Prato

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: STEMI; NSTEMI; Acute kidney injury; Renal function; Statin therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: OSS 15.161

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No