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

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. Identifier: NCT01007279
Recruitment Status : Completed
First Posted : November 4, 2009
Last Update Posted : October 26, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Periprocedural Myocardial Necrosis Drug: ROSUVASTATIN Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis
Study Start Date : March 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
40 mg before procedure
40 mg before procedure

Primary Outcome Measures :
  1. Myocardial enzymes arise [ Time Frame: 6-12-24 hours ]

Secondary Outcome Measures :
  1. MACE [ Time Frame: 1-6-9 MONTHS ]

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

Inclusion Criteria:

  • Patients with stable angina

Exclusion Criteria:

  • Baseline myocardial enzyme rise

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 identifier (NCT number): NCT01007279

Policlinico Umberto I
Rome, Italy, 00166
Sponsors and Collaborators
University of Roma La Sapienza

Responsible Party: GENNARO SARDELLA, POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME Identifier: NCT01007279     History of Changes
Other Study ID Numbers: ROMA55
First Posted: November 4, 2009    Key Record Dates
Last Update Posted: October 26, 2010
Last Verified: March 2010

Keywords provided by University of Roma La Sapienza:
Percutaneous angioplasty
Myocardial Infarction

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