Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
500 participants
INTERVENTIONAL
2010-07-31
2012-10-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Rosuvastatin
Rosuvastatin
One oral single dose of rosuvastatin of 40 mg at admission and then 20 mg/day for 1 month.
Control
No interventions assigned to this group
Interventions
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Rosuvastatin
One oral single dose of rosuvastatin of 40 mg at admission and then 20 mg/day for 1 month.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. pregnancy or lactation
3. intolerance to statins
4. therapy with other lipid lowering drugs
5. acute or chronic liver disease
6. chronic muscle disease
7. acute renal failure or chronic renal failure stage IV
8. neoplastic
9. exposure to iodinated contrast medium in the previous 10 days
18 Years
90 Years
ALL
No
Sponsors
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Centro Cardiopatici Toscani
OTHER
Responsible Party
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Anna Toso
MD
Principal Investigators
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Anna Toso, MD
Role: STUDY_CHAIR
Misericordia e Dolce, Prato Hospital, Cardiology Unit
Locations
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Cardiology Division, Prato Hospital
Prato, Prato, Italy
Countries
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References
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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.
Leoncini 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.
Leoncini 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.
Other Identifiers
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552010
Identifier Type: -
Identifier Source: org_study_id