Status:
TERMINATED
Rosuvastatin for Reduction of Myocardial Damage and Systemic Inflammation During Coronary Angioplasty
Lead Sponsor:
G. d'Annunzio University
Collaborating Sponsors:
Working Group Aterosclerosi, Trombosi e Biologia Vascolare
Conditions:
Stable Coronary Artery Disease Undergoing PCI
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
Myocardial necrosis is relatively frequent after percutaneous coronary intervention and is associated with higher mortality during the follow-up. Since anti-inflammatory properties of statins have be...
Detailed Description
Myocardial necrosis, assessed by creatine kinase-MB (CK-MB) elevation, is relatively frequent after percutaneous coronary intervention (PCI), occurring in up to 40% of cases. Although most patients re...
Eligibility Criteria
Inclusion
- \- suspected CAD for which an indication to PCI is given: both patients with stable CAD, and stable post-acute coronary syndromes (ACS), both with ST-segment elevation (STEMI) and without ST-segment elevation (NSTE-ACS) patients, provided that markers of myocardial necrosis (CK-MB, troponins) are stabilized (i.e., with variations \<20% in two consecutive measurements obtained at ≥6 h time distance before PCI, according to the universal definition of peri-procedural myocardial infarction).
Exclusion
- any previously known increase in liver enzymes (AST, ALT) ascribed to liver dysfunction at baseline;
- history of liver toxicity or myopathy on previous treatment with statins;
- left ventricular ejection fraction \<30%;
- renal insufficiency, with creatinine \>2 mg/dL at baseline;
- ongoing treatment with high-dose statins (atorvastatin 80 mg/d or rosuvastatin 40 mg/d);
- pregnant or lactating women.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT02205775
Start Date
May 1 2010
End Date
June 1 2012
Last Update
July 31 2014
Active Locations (6)
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1
SS. Annunziata Hospital
Chieti, CH, Italy, 66100
2
Fondazione IRCCS Policlinico S. Matteo
Pavia, PV, Italy, 27100
3
A.O. S. Anna e S. Sebastiano - II Università di Napoli
Caserta, Italy, 81100
4
Azienda ASL 6 - P. Ospedaliero Livorno
Livorno, Italy, 57100