Acute Coronary SyndromePhase 4PRATO-ACSNCT01185938
Statin Contrast Induced Nephropathy Prevention
A Phase 4 study testing Rosuvastatin in people with Acute Coronary Syndrome, run by Centro Cardiopatici Toscani at 1 site in Italy.
Trial summary
This open-label study, prospective, randomized trial evaluating the acute (in-hospital) pleiotropic and clinical effects of a hydrophilic statin (rosuvastatin) in patients with acute coronary syndrome Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2010to Oct 2012
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are eligible for the study all patients admitted to CCU for Acute Coronary Syndrome without ST elevation (NSTEMI) candidates for early invasive strategy (coronary angiography within 48 hours from the admission) and without previous therapy with statins.
Who cannot join
- inability to provide consent
- pregnancy or lactation
- intolerance to statins
- therapy with other lipid lowering drugs
- acute or chronic liver disease
- chronic muscle disease
Show all 9Show fewer
- acute renal failure or chronic renal failure stage IV
- neoplastic
- exposure to iodinated contrast medium in the previous 10 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protective Effect of Rosuvastatin and Antiplatelet Therapy On Contrast-induced Nephropathy and Myocardial Damage in Patients With Acute Coronary Syndrome Undergoing Coronary Intervention; PRATO-ACS Trial
This open-label study, prospective, randomized trial evaluating the acute (in-hospital) pleiotropic and clinical effects of a hydrophilic statin (rosuvastatin) in patients with acute coronary syndrome
Read the detailed description
The primary purpose of this study is to determine whether, in patients with acute coronary syndromes not taking statins in chronic administration, high doses of a hydrophilic statin (rosuvastatin) administered before coronary angiography and/or angioplasty, may exert a renal-protective effect by reducing the incidence of contrast nephropathy. Contrast induced nephropathy is defined as increased values of creatinine >= 0.3 mg/dl from baseline values, within 72 hours after contrast medium exposure.
Secondary end points: 1) verify if short-term (<48 hours)statin administration reduces the peak levels and the curve areas of markers of myocardial necrosis throughout the hospitalization period and if reduces the occurrence of periprocedural infarction. Biochemical markers (quantitative creatine kinase-MB (CK-MB) mass and Troponin I) are measured at admission and at 6, 12, and 24 hours during the first day then once daily, immediately before angiography, and 24 hours thereafter. In patients who underwent coronary angioplasty (PCI), biochemical markers were measured at 12 and 24 hours after the procedure. Data were fitted, peak values and curve areas calculated; the occurrence of periprocedural infarction was defined as a CK-MB mass elevation more than three times the upper limit of normal within 24 hours after PCI. 2) determine the distribution of peripheral lymphocytic populations at the entry and at discharge using the flow cytometric analysis; 3) analyze the clinical composite outcome of death, myocardial infarction, urgent revascularization, dialysis and stroke at 30 days and 6 months.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Rosuvastatin
- Keywords
- statin, CIN, periprocedural 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
One oral single dose of rosuvastatin of 40 mg at admission and then 20 mg/day for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Active comparator | Not described Receives: Drug: Rosuvastatin |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of contrast-induced nephropathy in patients with Acute Coronary Syndrome treated with rosuvastatin versus control
Measured: 3 days
Secondary outcomes (3)
Peak levels and curve areas of myocardial necrosis markers measured throughout the hospitalization period.
Quantitative creatine kinase-MB (CK-MB) mass and cTn I were measured at admission and at 6, 12, and 24 hours during the first day then once daily, immediately before angiography, and 24 hours thereafter. In patients who underwent angioplasty, biochemical markers were measured at 12 and 24 hours after procedure.
Measured: 5 days (average)
Distribution of peripheral lymphocyte populations at the entry and at discharge
Comparison between groups for the distribution of peripheral lymphocyte sub-population evaluated bu Flow Cytometric Analysis at the admission and at discharge.
Measured: 5 days (average)
Incidence of clinical composite outcome (death, myocardial infarction, urgent revascularization, dialysis and stroke).
Clinical follow-up at 30 days and 6 month after the hospitalization for the Acute Coronary Syndrome.
Measured: 30 days and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiopatici Toscani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Toso, Centro Cardiopatici Toscani
- Investigators
- Anna Toso, MD, Study chair, Misericordia e Dolce, Prato Hospital, Cardiology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185938
- Sponsor's protocol ID
- 552010
- Acronym
- PRATO-ACS
- Status last verified
- Oct 2012
- First submitted
- 3 Aug 2010
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Toso A, Leoncini M, Maioli M, Tropeano F, Di Vincenzo E, Villani S, Bellandi F. Relationship between inflammation and benefits of early high-dose rosuvastatin on contrast-induced nephropathy in patients with acute coronary syndrome: the pathophysiological link in the PRATO-ACS study (Protective Effect of Rosuvastatin and Antiplatelet Therapy on Contrast-Induced Nephropathy and Myocardial Damage in Patients With Acute Coronary Syndrome Undergoing Coronary Intervention). JACC Cardiovasc Interv. 2014 Dec;7(12):1421-9. doi: 10.1016/j.jcin.2014.06.023.
PubMed 25523533Leoncini M, Toso A, Maioli M, Tropeano F, Badia T, Villani S, Bellandi F. Early high-dose rosuvastatin and cardioprotection in the protective effect of rosuvastatin and antiplatelet therapy on contrast-induced acute kidney injury and myocardial damage in patients with acute coronary syndrome (PRATO-ACS) study. Am Heart J. 2014 Nov;168(5):792-7. doi: 10.1016/j.ahj.2014.08.005. Epub 2014 Aug 10.
PubMed 25440809Leoncini M, Toso A, Maioli M, Tropeano F, Villani S, Bellandi F. Early high-dose rosuvastatin for contrast-induced nephropathy prevention in acute coronary syndrome: Results from the PRATO-ACS Study (Protective Effect of Rosuvastatin and Antiplatelet Therapy On contrast-induced acute kidney injury and myocardial damage in patients with Acute Coronary Syndrome). J Am Coll Cardiol. 2014 Jan 7-14;63(1):71-9. doi: 10.1016/j.jacc.2013.04.105. Epub 2013 Sep 26.
PubMed 24076283
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of Rosuvastatin and Antiplatelet Therapy On Contrast-induced Nephropathy and Myocardial Damage in Patients With Acute Coronary Syndrome Undergoing Coronary Intervention; PRATO-ACS Trial
- ClinicalTrials.gov ID
- NCT01185938
- Acronym / sponsor ID
- PRATO-ACS / 552010
- Conditions
- Acute Coronary Syndrome
- Keywords
- statin, CIN, periprocedural damage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Centro Cardiopatici ToscaniUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Aug 2010 (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.
This open-label study, prospective, randomized trial evaluating the acute (in-hospital) pleiotropic and clinical effects of a hydrophilic statin (rosuvastatin) in patients with acute coronary syndrome
Detailed description
The primary purpose of this study is to determine whether, in patients with acute coronary syndromes not taking statins in chronic administration, high doses of a hydrophilic statin (rosuvastatin) administered before coronary angiography and/or angioplasty, may exert a renal-protective effect by reducing the incidence of contrast nephropathy. Contrast induced nephropathy is defined as increased values of creatinine >= 0.3 mg/dl from baseline values, within 72 hours after contrast medium exposure.
Secondary end points: 1) verify if short-term (<48 hours)statin administration reduces the peak levels and the curve areas of markers of myocardial necrosis throughout the hospitalization period and if reduces the occurrence of periprocedural infarction. Biochemical markers (quantitative creatine kinase-MB (CK-MB) mass and Troponin I) are measured at admission and at 6, 12, and 24 hours during the first day then once daily, immediately before angiography, and 24 hours thereafter. In patients who underwent coronary angioplasty (PCI), biochemical markers were measured at 12 and 24 hours after the procedure. Data were fitted, peak values and curve areas calculated; the occurrence of periprocedural infarction was defined as a CK-MB mass elevation more than three times the upper limit of normal within 24 hours after PCI. 2) determine the distribution of peripheral lymphocytic populations at the entry and at discharge using the flow cytometric analysis; 3) analyze the clinical composite outcome of death, myocardial infarction, urgent revascularization, dialysis and stroke at 30 days and 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Active comparator | Drug: Rosuvastatin |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Are eligible for the study all patients admitted to CCU for Acute Coronary Syndrome without ST elevation (NSTEMI) candidates for early invasive strategy (coronary angiography within 48 hours from the admission) and without previous therapy with statins.
Key exclusion criteria (9 listed)
- inability to provide consent
- pregnancy or lactation
- intolerance to statins
- therapy with other lipid lowering drugs
- acute or chronic liver disease
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 |
|---|---|---|
| RosuvastatinOne oral single dose of rosuvastatin of 40 mg at admission and then 20 mg/day for 1 month. | Drug | Rosuvastatin |
Primary outcome
Incidence of contrast-induced nephropathy in patients with Acute Coronary Syndrome treated with rosuvastatin versus control
Time frame: 3 days
3 secondary outcomes
Peak levels and curve areas of myocardial necrosis markers measured throughout the hospitalization period.
Time frame: 5 days (average)
Distribution of peripheral lymphocyte populations at the entry and at discharge
Time frame: 5 days (average)
Incidence of clinical composite outcome (death, myocardial infarction, urgent revascularization, dialysis and stroke).
Time frame: 30 days and 6 months
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 19 Oct 2012.
- Derived from this study: PubMed 25523533Toso A, Leoncini M, Maioli M, Tropeano F, Di Vincenzo E, Villani S, Bellandi F. Relationship between inflammation and benefits of early high-dose rosuvastatin on contrast-induced nephropathy in patients with acute coronary syndrome: the pathophysiological link in the PRATO-ACS study (Protective Effect of Rosuvastatin and Antiplatelet Therapy on Contrast-Induced Nephropathy and Myocardial Damage in Patients With Acute Coronary Syndrome Undergoing Coronary Intervention). JACC Cardiovasc Interv. 2014 Dec;7(12):1421-9. doi: 10.1016/j.jcin.2014.06.023.
- Derived from this study: PubMed 25440809Leoncini M, Toso A, Maioli M, Tropeano F, Badia T, Villani S, Bellandi F. Early high-dose rosuvastatin and cardioprotection in the protective effect of rosuvastatin and antiplatelet therapy on contrast-induced acute kidney injury and myocardial damage in patients with acute coronary syndrome (PRATO-ACS) study. Am Heart J. 2014 Nov;168(5):792-7. doi: 10.1016/j.ahj.2014.08.005. Epub 2014 Aug 10.
- Derived from this study: PubMed 24076283Leoncini M, Toso A, Maioli M, Tropeano F, Villani S, Bellandi F. Early high-dose rosuvastatin for contrast-induced nephropathy prevention in acute coronary syndrome: Results from the PRATO-ACS Study (Protective Effect of Rosuvastatin and Antiplatelet Therapy On contrast-induced acute kidney injury and myocardial damage in patients with Acute Coronary Syndrome). J Am Coll Cardiol. 2014 Jan 7-14;63(1):71-9. doi: 10.1016/j.jacc.2013.04.105. Epub 2013 Sep 26.
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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 study chair
Misericordia e Dolce, Prato Hospital, Cardiology Unit
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 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 9 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 19 Oct 2012. 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?
Incidence of contrast-induced nephropathy in patients with Acute Coronary Syndrome treated with rosuvastatin versus control (time frame: 3 days). 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 NCT01185938, which also lists 3 linked publications.
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 19 Oct 2012.