NCT01007279

Rosuvastatin in Preventing Myonecrosis in Elective Percutaneous Coronary Interventions (PCIs)

ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients after otherwise successful percutaneous coronary interventions (PCIs)(1) Apart from side-branch occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after PCI might be distal embolization of atherogenic materials from plaque disruption,(2 )causing obstruction of blood flow at capillary level resulting in micro-infarction.(3,4 )Recent studies have suggested that pretreatment with Atorvastatin may be associated with a reduction in infarct size after elective PCI. (5-7 ).Actually the standard pretreatment in patients undergoing elective coronary-PCI and already treated with aspirin is copidogrel loading dose administration before procedure.(8,9 ) The investigators hypothesized that a high (40mg) loading dose of Rosuvastatin administered within 24h before the procedure may be effective in reducing the rate of periprocedural MI.Therefore, the investigators will conduct a single center,prospective randomized study to assess whether a single,high (40mg) loading (within24h)dose of Rosuvastatin is effective in preventing elevation of biomarkers of MI after elective coronary stent implantation.

Conditions

• Periprocedural Myocardial Necrosis

Interventions

Type	Name	Description
DRUG	ROSUVASTATIN	40 mg before procedure

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-11-04
• Last updated: 2010-10-26

Locations

1 site across 1 country: Italy