Acute Coronary SyndromePRATO-ACSNCT04087200
Protective Effect of Early High Dose stATins On Cardiovascular and Renal Events in Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by Centro Cardiopatici Toscani at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 2,500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2016to 1 Dec 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Statin-naive patients and those on statin therapy with ACS (both STEMI and NSTEMI)
Who may be able to join
- Acute coronary syndrome (ST elevation and non ST elevation)
- Early invasive strategy
Who cannot join
- contraindication to statin therapy
- refusal of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Cardiology Division, Prato Hospital
Prato, 59100
Anna Toso, MD, +390574434396, anna.toso@libero.it
Mario Leoncini, MD, +390574434270, leoncini.mario@tiscali.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Keywords
- STEMI, NSTEMI, Acute kidney injury, Renal function, Statin therapy
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute renal function changes
Changes in creatinine and/or cystatine values
Measured: Within 72 hours after hospital admission
Inflammatory profile changes
Changes from baseline in CRP values
Measured: up to 1 month
Lipid profile changes
Changes from baseline in cholesterol values
Measured: up to 1 month
Platelet count
Changes from baseline in platelet count
Measured: up to 1 month
Platelet volume
Changes from baseline in platelet volume
Measured: up to 1 month
Platelet aggregation profile
Changes from baseline in platelet reactivity (Verify Now)
Measured: up to 1 month
Secondary outcomes (3)
Major cardiovascular adverse events
Death, myocardial infarction, stroke or coronary revascularization
Measured: up to 12 months
Renal function changes
glomerular filtration rate
Measured: 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
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Dec 2016
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Centro Cardiopatici Toscani
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL 4 Prato
- Responsible party
- Principal investigator, Anna Toso, Centro Cardiopatici Toscani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087200
- Sponsor's protocol ID
- OSS 15.161
- Acronym
- PRATO-ACS
- Status last verified
- Sep 2019
- First submitted
- 30 Aug 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protective Effect of Early High Dose High-intensity Statins on Cardiovascular and Renal Events in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04087200
- Acronym / sponsor ID
- PRATO-ACS / OSS 15.161
- Conditions
- Acute Coronary Syndrome
- Keywords
- STEMI, NSTEMI, Acute kidney injury, Renal function, Statin therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Centro Cardiopatici ToscaniUniversity, hospital or other
- Collaborators
- Azienda USL 4 Prato
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Statin-naive patients and those on statin therapy with ACS (both STEMI and NSTEMI)
Key inclusion criteria (2 listed)
- Acute coronary syndrome (ST elevation and non ST elevation)
- Early invasive strategy
Key exclusion criteria (2 listed)
- contraindication to statin therapy
- refusal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute renal function changes
Time frame: Within 72 hours after hospital admission
Changes in creatinine and/or cystatine values
Inflammatory profile changes
Time frame: up to 1 month
Changes from baseline in CRP values
Lipid profile changes
Time frame: up to 1 month
Changes from baseline in cholesterol values
Platelet count
Time frame: up to 1 month
Changes from baseline in platelet count
Platelet volume
Time frame: up to 1 month
Changes from baseline in platelet volume
Platelet aggregation profile
Time frame: up to 1 month
Changes from baseline in platelet reactivity (Verify Now)
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Centro Cardiopatici Toscani at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Toso, MD (00393387982507, anna.toso@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute renal function changes (time frame: Within 72 hours after hospital admission). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.