Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04087200
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Azienda USL 4 Prato
Information provided by (Responsible Party):
Anna Toso, Centro Cardiopatici Toscani

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.

Condition or disease
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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: The Protective Effect of Early High Dose High-intensity Statins on Cardiovascular and Renal Events in Patients With Acute Coronary Syndrome
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 1, 2026

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Statin-naive patients and those on statin therapy with ACS (both STEMI and NSTEMI)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindication to statin therapy
  • refusal of consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087200


Contacts
Layout table for location contacts
Contact: Anna Toso, MD 00393387982507 anna.toso@libero.it
Contact: Mario Leoncini, MD 0039-0574803738 leoncini.mario@tiscali.it

Locations
Layout table for location information
Italy
Cardiology Division, Prato Hospital Recruiting
Prato, Italy, 59100
Contact: Anna Toso, MD    +390574434396    anna.toso@libero.it   
Contact: Mario Leoncini, MD    +390574434270    leoncini.mario@tiscali.it   
Sub-Investigator: Francesco Bellandi, MD         
Sub-Investigator: Francesco Tropeano, MD         
Sub-Investigator: Mauro Maioli, MD         
Sub-Investigator: Nicola Musilli, MD         
Sponsors and Collaborators
Centro Cardiopatici Toscani
Azienda USL 4 Prato

Layout table for additonal information
Responsible Party: Anna Toso, Principal Investigator, Centro Cardiopatici Toscani
ClinicalTrials.gov Identifier: NCT04087200     History of Changes
Other Study ID Numbers: OSS 15.161
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Toso, Centro Cardiopatici Toscani:
STEMI
NSTEMI
Acute kidney injury
Renal function
Statin therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents