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CEREA-DES
Cortisone plus BMS or DES versus BMS alone to eliminate restenosis
Ongoing trial
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Author(s) |
Ribichini F, Tomai F, De Luca G, Boccuzzi G, Presbitero P, Pesarini G, Ferrero V, Ghini AS, Pastori F, De Luca L, Zavalloni D, Soregaroli D, Garbo R, Franchi E, Marino P, Minelli M, Vassanelli C |
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Title(s) |
A multicenter, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: cortisone plus BMS or DES versus BMS alone to eliminate restenosis (CEREA-DES) – study design and rationale |
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Reference(s) |
J Cardiovasc Med 2009;10:192–9 |
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Disease |
Coronary artery disease |
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Purpose |
To compare the cardiac event-free survival rate 1 year after PCI with drug-eluting stents or bare-metal stents plus prednisone vs bare-metal stents alone in patients with coronary artery disease. Secondary, to compare 9-month restenosis rate, long-term event-free survival and long-term cost-effectiveness between the three groups |
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Study design |
Randomised |
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Follow-up |
Aim 9 months, 1, 2 and 3 years |
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Patients |
Aim 375 patients with coronary artery disease without diabetes mellitus |
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Treatment regimen |
Drug-eluting stent or bare-metal stent plus oral prednisone, 1 mg/kg for 15 days, then 0.5 mg/kg on days 16–30, followed by 0.25 mg/kg on days 31–40, or bare-metal stent alone. Choice of drug-eluting stent (paclitaxel-eluting or sirolimus-eluting stent) at the discretion of the physician |
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Concomitant therapy |
Conventional medical treatment, including ticlopidine or clopidogrel, plus ASA, statins and heparin before and after PCI. GP IIb/IIIa inhibitors at the discretion of the physician. Gastroprotective antacid therapy and oral thiazides in patients receiving prednisone |
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Results |
Not yet available |
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