Rosuvastatin for Reduction of Myocardial Damage and Systemic Inflammation During Coronary Angioplasty

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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 been demonstrated and the benefit of statins in acute coronary syndromes have been proven, this study aims at testing the hypothesis that the pre-procedural intensive statin treatment reduce the extent of peri-procedural necrosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: G. d'Annunzio University
• Collaborator: Working Group Aterosclerosi, Trombosi e Biologia Vascolare
• Treatments: Atorvastatin; Atorvastatin Calcium; Ezetimibe; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.