Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04087200

Protective Effect of Early High Dose stATins On Cardiovascular and Renal Events in 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Coronary Syndrome Acute Kidney Injury Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Infarction Ischemia Kidney Diseases Male Urogenital Diseases Myocardial Infarction Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency ST Elevation Myocardial Infarction Urogenital Diseases Urologic Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology Division, Prato Hospital

Prato, 59100, Italy

Location status: Recruiting

Location contact

Anna Toso, MD

CONTACT

[email protected]

+390574434396

Francesco Bellandi, MD

SUB_INVESTIGATOR

Francesco Tropeano, MD

SUB_INVESTIGATOR

Mario Leoncini, MD

CONTACT

[email protected]

+390574434270

Mauro Maioli, MD

SUB_INVESTIGATOR

Nicola Musilli, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • contraindication to statin therapy
  • refusal of consent

Treatment and study plan

Primary outcomes

  1. Acute renal function changes

    Time frame: Within 72 hours after hospital admission

    Changes in creatinine and/or cystatine values

  2. Inflammatory profile changes

    Time frame: up to 1 month

    Changes from baseline in CRP values

  3. Lipid profile changes

    Time frame: up to 1 month

    Changes from baseline in cholesterol values

  4. Platelet count

    Time frame: up to 1 month

    Changes from baseline in platelet count

  5. Platelet volume

    Time frame: up to 1 month

    Changes from baseline in platelet volume

  6. Platelet aggregation profile

    Time frame: up to 1 month

    Changes from baseline in platelet reactivity (Verify Now)

Secondary outcomes

  1. Major cardiovascular adverse events

    Time frame: up to 12 months

    Death, myocardial infarction, stroke or coronary revascularization

  2. Renal function changes

    Time frame: Changes from baseline at 1 month

    glomerular filtration rate

  3. Major adverse cardiovascular and renal adverse events

    Time frame: up to 1 month

    Death, myocardial infarction, stroke, coronary revascularization or glomerular filtration rate reduction > = 25% compared to baseline

Other outcomes

  1. Impact of age and frailty profile on primary and secondary outcomes

    Time frame: Up to 1 month

    Frailty evaluation (combination of FRAIL scale questionnaire and hand-grip strength measurement)

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Toso, MD

CONTACT

[email protected]

00393387982507

Mario Leoncini, MD

CONTACT

[email protected]

0039-0574803738

Sponsors and collaborators

Lead sponsor

Centro Cardiopatici Toscani

Other

Collaborators

  • Azienda USL 4 Prato

Registry information

Official study title

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

Acronym: PRATO-ACS

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Sep 12, 2019
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.