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

NCT ID: NCT01228227

Last Updated: 2013-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-08-31

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.

Conditions

Assess the Periprocedural Myocardial Necrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ROSUVASTATIN

Group Type: ACTIVE_COMPARATOR

ROSUVASTATIN 40 mg

Intervention Type: DRUG

reload of rosuvastatin 40 mg before the procedure

ATORVASTATIN

Group Type: EXPERIMENTAL

ATORVASTATIN 80 mg

Intervention Type: DRUG

reload of Atorvastatin 80 mg before the procedure

Interventions

ATORVASTATIN 80 mg

reload of Atorvastatin 80 mg before the procedure

Intervention Type: DRUG

ROSUVASTATIN 40 mg

reload of rosuvastatin 40 mg before the procedure

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients with stable angina

Exclusion Criteria

Baseline myocardial enzyme rise

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gennaro Sardella

OTHER

Sponsor Role: lead

Responsible Party

Gennaro Sardella

Associate Professor in Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Policlinico Umberto I

Roma, Roma, Italy

Countries

Italy

Other Identifiers

ROMA II

Identifier Type: -

Identifier Source: org_study_id