Acute Coronary SyndromePhase 4PRATO-ACS-2NCT01870804
Atorvastatin Versus Rosuvastatin on Contrast Induced Acute Kidney Injury (PRATO-ACS 2)
A Phase 4 study testing Rosuvastatin and Atorvastatin in people with Acute Coronary Syndrome, run by Centro Cardiopatici Toscani at 1 site in Italy.
Trial summary
The aim of the project is to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury in patients with non-ST-elevation acute coronary syndromes scheduled for early invasive strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Rosuvastatin and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive statin-naive patients with non ST-elevation acute coronary syndrome admitted to our institution and scheduled for early invasive strategy are considered for enrollment
Who cannot join
- Current statin treatment
- High-risk features warranting emergency coronary angiography (within 2 hours)
- Acute renal failure or end-stage renal failure requiring dialysis or serum creatinine ≥ 3 mg/dl
- Severe comorbidities which precluded early invasive strategy
- Contraindications to statin treatment
- Contrast media administration within the last 10 days
- Pregnancy
- Refusal of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Early High-dose Atorvastatin Versus Rosuvastatin on Contrast Induced Acute Kidney Injury in Unselected Patients With Non- ST Elevation Acute Coronary Syndromes Scheduled for Early Invasive Strategy.
The aim of the project is to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury in patients with non-ST-elevation acute coronary syndromes scheduled for early invasive strategy.
Read the detailed description
This is a prospective, single-centre, randomized study, designed to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury (CI-AKI). Consecutive statin-naïve patients admitted in the investigators institution for non-ST elevation Acute Coronary Syndrome (NSTE-ACS) and scheduled for early invasive strategy will be eligible.
Patients are randomized into two groups: 1) high-dose rosuvastatin (40 mg on-admission followed by 20 mg/day); 2) high-dose atorvastatin (80 mg on-admission followed by 40 mg/day). Randomization will be performed on-admission by computerized open-label assignment in blinded envelopes used in a consecutive fashion. All patients receive the standard pre-procedural hydration. The primary end-point is the proportion of patients with an increase in serum creatinine of ≥ 0.5 mg/dl or ≥ 25% above baseline within 72 hours after contrast medium administration. The secondary end-points are persistent worsening of renal damage (eGFR reduction >= 25% at 30 days) and cumulative adverse clinical events at follow-up. Specifically: death, myocardial infarction, dialysis, stroke or persistent renal damage at 30 days; death or myocardial infarction at 6 and 12 months.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Rosuvastatin, Atorvastatin
- Keywords
- Statins, Contrast-Induced Acute Kidney Injury, Periprocedural Myocardial Damage
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
AtorvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Active comparator | Rosuvastatin (40 mg on-admission followed by 20 mg/day) until discharge; then 20 mg/day (10 mg/day if creatinine clearance < 30 ml/min) Receives: Drug: Rosuvastatin |
| Atorvastatin | Active comparator | atorvastatin (80 mg on-admission followed by 40 mg/day before and after discharge) Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast Induced-Acute Kidney Injury
Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure
Measured: 72 hours
Secondary outcomes (5)
Renal function at 30 days
Estimation of the glomerular filtration rate in all patients at 30 days
Measured: 30 days after discharge
Cardiovascular and renal outcome
Composite cardiovascular and renal events at follow-up including acute renal failure requiring dialysis, persistent renal damage, all-causes mortality, myocardial infarction or stroke.
Measured: 30 days, 6 months, 12 months
Anti-inflammatory effect of rosuvastatin and atorvastatin
High-sensitivity C-reactive protein (hs-CRP)will be measured on admission, at discharge and at 30 days.
Measured: On admission (baseline), at discharge (after 5 days) & at 30 days
Lipid-modulatory effects of atorvastatin and rosuvastatin
Low density lipoprotein (LDL) levels will be determined on admission, at discharge and at 30 days.
Measured: On admission (baseline), at discharge (after 5 days) & at 30 days
Myocardial Damage
Total cardiac biomarkers release during the index event
Measured: During hospitalization (average 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiopatici Toscani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Toso, Ospedale Misericordia e Dolce
- Investigators
- Anna Toso, MD, Principal investigator, Prato Hospital, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870804
- Sponsor's protocol ID
- 472013
- Acronym
- PRATO-ACS-2
- Status last verified
- Oct 2016
- First submitted
- 30 May 2013
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Toso A, Leoncini M, Maioli M, Tropeano F, Villani S, Bellandi F. A Prospective, Randomized, Open-Label Trial of Atorvastatin versus Rosuvastatin in the Prevention of Contrast-Induced Acute Kidney Injury, Worsened Renal Function at 30 Days, and Clinical Events After Acute Coronary Angiography: the PRATO-ACS-2 Study. Cardiorenal Med. 2020;10(5):288-301. doi: 10.1159/000506857. Epub 2020 May 20.
PubMed 32434204
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early High-dose Atorvastatin Versus Rosuvastatin on Contrast Induced Acute Kidney Injury in Unselected Patients With Non- ST Elevation Acute Coronary Syndromes Scheduled for Early Invasive Strategy.
- ClinicalTrials.gov ID
- NCT01870804
- Acronym / sponsor ID
- PRATO-ACS-2 / 472013
- Conditions
- Acute Coronary Syndrome
- Keywords
- Statins, Contrast-Induced Acute Kidney Injury, Periprocedural Myocardial Damage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- Centro Cardiopatici ToscaniUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Jun 2013 (estimated)
- 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.
The aim of the project is to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury in patients with non-ST-elevation acute coronary syndromes scheduled for early invasive strategy.
Detailed description
This is a prospective, single-centre, randomized study, designed to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury (CI-AKI). Consecutive statin-naïve patients admitted in the investigators institution for non-ST elevation Acute Coronary Syndrome (NSTE-ACS) and scheduled for early invasive strategy will be eligible.
Patients are randomized into two groups: 1) high-dose rosuvastatin (40 mg on-admission followed by 20 mg/day); 2) high-dose atorvastatin (80 mg on-admission followed by 40 mg/day). Randomization will be performed on-admission by computerized open-label assignment in blinded envelopes used in a consecutive fashion. All patients receive the standard pre-procedural hydration. The primary end-point is the proportion of patients with an increase in serum creatinine of ≥ 0.5 mg/dl or ≥ 25% above baseline within 72 hours after contrast medium administration. The secondary end-points are persistent worsening of renal damage (eGFR reduction >= 25% at 30 days) and cumulative adverse clinical events at follow-up. Specifically: death, myocardial infarction, dialysis, stroke or persistent renal damage at 30 days; death or myocardial infarction at 6 and 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Active comparator | Drug: RosuvastatinRosuvastatin (40 mg on-admission followed by 20 mg/day) until discharge; then 20 mg/day (10 mg/day if creatinine clearance < 30 ml/min) |
| Atorvastatin | Active comparator | Drug: Atorvastatinatorvastatin (80 mg on-admission followed by 40 mg/day before and after discharge) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive statin-naive patients with non ST-elevation acute coronary syndrome admitted to our institution and scheduled for early invasive strategy are considered for enrollment
Key exclusion criteria (8 listed)
- Current statin treatment
- High-risk features warranting emergency coronary angiography (within 2 hours)
- Acute renal failure or end-stage renal failure requiring dialysis or serum creatinine ≥ 3 mg/dl
- Severe comorbidities which precluded early invasive strategy
- Contraindications to statin treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin | Drug | Rosuvastatin |
| Atorvastatin | Drug | Atorvastatin |
Primary outcome
Contrast Induced-Acute Kidney Injury
Time frame: 72 hours
Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure
5 secondary outcomes
Renal function at 30 days
Time frame: 30 days after discharge
Cardiovascular and renal outcome
Time frame: 30 days, 6 months, 12 months
Anti-inflammatory effect of rosuvastatin and atorvastatin
Time frame: On admission (baseline), at discharge (after 5 days) & at 30 days
Lipid-modulatory effects of atorvastatin and rosuvastatin
Time frame: On admission (baseline), at discharge (after 5 days) & at 30 days
Myocardial Damage
Time frame: During hospitalization (average 5 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Derived from this study: PubMed 32434204Toso A, Leoncini M, Maioli M, Tropeano F, Villani S, Bellandi F. A Prospective, Randomized, Open-Label Trial of Atorvastatin versus Rosuvastatin in the Prevention of Contrast-Induced Acute Kidney Injury, Worsened Renal Function at 30 Days, and Clinical Events After Acute Coronary Angiography: the PRATO-ACS-2 Study. Cardiorenal Med. 2020;10(5):288-301. doi: 10.1159/000506857. Epub 2020 May 20.
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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. This study is not recruiting at the moment.
Anna Toso, MD principal investigator
Prato Hospital, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin and Atorvastatin in people with 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 6 Oct 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast Induced-Acute Kidney Injury (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01870804, which also lists 1 linked publication.
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 6 Oct 2016.