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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
  Purpose
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.

Condition Intervention Phase
Assess the Periprocedural Myocardial Necrosis Drug: ATORVASTATIN 80 mg Drug: ROSUVASTATIN 40 mg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Loading ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis : Comparison With Atorvastatin High Dose Reloading.

Resource links provided by NLM:


Further study details as provided by Gennaro Sardella, University of Roma La Sapienza:

Primary Outcome Measures:
  • Myocardial enzymes arise [ Time Frame: 12- 24 hours ]

Secondary Outcome Measures:
  • MACCE [ Time Frame: 1-6-12 Months ]

Estimated Enrollment: 310
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ROSUVASTATIN Drug: ROSUVASTATIN 40 mg
reload of rosuvastatin 40 mg before the procedure
Experimental: ATORVASTATIN Drug: ATORVASTATIN 80 mg
reload of Atorvastatin 80 mg before the procedure

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with stable angina

Exclusion Criteria:

Baseline myocardial enzyme rise

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228227


Locations
Italy
Policlinico Umberto I
Roma, Italy
Sponsors and Collaborators
Gennaro Sardella
  More Information

Responsible Party: Gennaro Sardella, Associate Professor in Cardiology, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01228227     History of Changes
Other Study ID Numbers: ROMA II
First Submitted: October 18, 2010
First Posted: October 26, 2010
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by Gennaro Sardella, University of Roma La Sapienza:
Myonecrosis
Percutaneous Angioplasty
Myocardial Infarction

Additional relevant MeSH terms:
Necrosis
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin Calcium
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors