ROsuvastatin Pretreatment to Reduce MyocArdial Periprocedural Necrosis:Comparison With Atorvastatin Reloading

Phase 3

Completed

• Conditions: Assess the Periprocedural Myocardial Necrosis
• Interventions: Drug: ROSUVASTATIN 40 mg; Drug: ATORVASTATIN 80 mg

• Registration Number: NCT01228227
• Lead Sponsor: Gennaro Sardella

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 clopidogrel loading dose administration before procedure.(8,9)The investigators compared a high (80mg) re-loading dose of Atorvastatin with a high loading dose of Rosuvastatin (40 mg) both administered within 24h before the procedure in reducing the rate of periprocedural MI. Therefore, the investigators will conduct a single center, prospective randomized study to assess whether a single, high (80mg) loading (within 24h)dose of Atorvastatin compared with a single loading dose of Rosuvastatin (20 mg) is effective in preventing elevation of biomarkers of MI after elective coronary stent implantation. We evaluate the incidence of MACCE(occurring of cardiac death, myocardial infarction (including periprocedural myonecrosis) and stroke at 30 days 6 and 12 month follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Primary Completion: 2011-04
• Study Completion: 2011-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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
ROSUVASTATIN	ROSUVASTATIN 40 mg	-
ATORVASTATIN	ATORVASTATIN 80 mg	-

Primary Outcome Measures

Name	Time	Method
Myocardial enzymes arise	12- 24 hours

Secondary Outcome Measures

Name	Time	Method
MACCE	1-6-12 Months

Trial Locations

Locations (1)

Policlinico Umberto I; 🇮🇹 Roma, Italy