Protective Effect of Early High Dose stATins On Cardiovascular and Renal Events in Acute Coronary Syndrome

NCT04087200 | Recruiting

• 1 other identifier: OSS 15.161
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

STEMI; NSTEMI; Acute kidney injury; Renal function; Statin therapy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Major cardiovascular adverse events

  up to 12 months

• Renal function changes

  Changes from baseline at 1 month

• Major adverse cardiovascular and renal adverse events

  up to 1 month

Other Outcomes (1)

• Impact of age and frailty profile on primary and secondary outcomes

  Up to 1 month

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• contraindication to statin therapy
• refusal of consent

Sponsors & Collaborators

• Centro Cardiopatici Toscani: lead
• Azienda USL 4 Prato: collaborator

Study Sites (1)

Cardiology Division, Prato Hospital

Prato, 59100, Italy

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Anna Toso, MD

CONTACT

00393387982507; anna.toso@libero.it

Mario Leoncini, MD

CONTACT

0039-0574803738; leoncini.mario@tiscali.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 12, 2019
• Study Start: December 1, 2016
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

IT (1)