Title |
Rosuvastatin for Reduction of Myocardial Damage during Coronary Angioplasty - the Remedy Trial
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Published in |
Cardiovascular Drugs and Therapy, June 2016
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DOI | 10.1007/s10557-016-6672-3 |
Pubmed ID | |
Authors |
Carlo Briguori, Rosalinda Madonna, Marco Zimarino, Paolo Calabrò, Cristina Quintavalle, Maria Salomone, Gerolama Condorelli, Raffaele De Caterina |
Abstract |
Periprocedural myocardial infarction (MI) is a frequent complication of percutaneous coronary intervention (PCI). Statins might reduce its incidence. The aims of the present study are to assess whether such benefit is a class-effect or whether differences exist between various lipid-lowering strategies and whether cardioprotection is exerted by increasing circulating endothelial progenitor cells (EPCs). The REMEDY study will enroll a total of 1080 patients submitted to elective PCI. Eligible patients will be randomized into 4 groups: 1) placebo; 2) atorvastatin (80 mg + 40 mg before PCI); 3) rosuvastatin (40 mg twice before PCI); and 4) rosuvastatin (5 mg) and ezetimibe (10 mg) twice before PCI. Peri-procedural MI is defined as an elevation of markers of cardiac injury (either CK-MB or troponin I or T) values >5x the upper reference limit estimated at the 99th percentile of the normal distribution, or a rise >20 % in case of baseline values already elevated. EPCs will be assessed before, at 24 h and - in a subset of diabetic patients - at 3 months after PCI (EPC-substudies). The primary endpoint of the main REMEDY study is the rate of peri-procedural MI in each of the 4 treatment arms. Secondary endpoints are the combined occurrence of 1-month major adverse events (MACE, including death, MI, or the need for unplanned revascularization); and any post-procedural increase in serum creatinine. Endpoints of the EPC-substudies are the impact of tested regimens on 1) early (24-h) and 3-month EPC levels and functional activity; 2) stent strut re-endothelialization and neointimal hyperplasia; 3) 1-year MACE. REMEDY will add important information on the cardioprotective effects of statins after PCI. |
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United Kingdom | 1 | 100% |
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Members of the public | 1 | 100% |
Mendeley readers
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Student > Master | 10 | 15% |
Student > Bachelor | 7 | 11% |
Researcher | 7 | 11% |
Student > Postgraduate | 7 | 11% |
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Other | 8 | 12% |
Unknown | 22 | 34% |
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Business, Management and Accounting | 1 | 2% |
Other | 2 | 3% |
Unknown | 25 | 38% |