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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01228227

First Posted: October 26, 2010

Last Update Posted: January 4, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Gennaro Sardella, University of Roma La Sapienza

Tracking Information

First Submitted Date ^ICMJE

October 18, 2010

First Posted Date ^ICMJE

October 26, 2010

Last Update Posted Date

January 4, 2013

Start Date ^ICMJE

October 2010

Primary Completion Date

April 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Myocardial enzymes arise [ Time Frame: 12- 24 hours ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01228227 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

MACCE [ Time Frame: 1-6-12 Months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

High Loading ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis : Comparison With Atorvastatin High Dose Reloading.

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Assess the Periprocedural Myocardial Necrosis

Intervention ^ICMJE

Drug: ATORVASTATIN 80 mg
reload of Atorvastatin 80 mg before the procedure
Drug: ROSUVASTATIN 40 mg
reload of rosuvastatin 40 mg before the procedure

Study Arms

Active Comparator: ROSUVASTATIN
Intervention: Drug: ROSUVASTATIN 40 mg
Experimental: ATORVASTATIN
Intervention: Drug: ATORVASTATIN 80 mg

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

310

Completion Date

August 2011

Primary Completion Date

April 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with stable angina

Exclusion Criteria:

Baseline myocardial enzyme rise

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Italy

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01228227

Other Study ID Numbers ^ICMJE

ROMA II

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Gennaro Sardella, University of Roma La Sapienza

Study Sponsor ^ICMJE

Gennaro Sardella

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

University of Roma La Sapienza

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top