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

Phase 3

Completed

• Conditions: Periprocedural Myocardial Necrosis
• Interventions: Drug: ROSUVASTATIN

• Registration Number: NCT01007279
• Lead Sponsor: University of Roma La Sapienza

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-04
• Status Verified: 2010-03
• Study Start: 2010-03
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-10-25
• Last Update Posted: 2010-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients with stable angina

Exclusion Criteria

• Baseline myocardial enzyme rise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CLOPIDOGREL	ROSUVASTATIN	-
ROSUVASTATIN	ROSUVASTATIN	-

Primary Outcome Measures

Name	Time	Method
Myocardial enzymes arise	6-12-24 hours

Secondary Outcome Measures

Name	Time	Method
MACE	1-6-9 MONTHS

Trial Locations

Locations (1)

Policlinico Umberto I; 🇮🇹 Rome, Italy