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

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

Study Description
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 Design

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
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: CLOPIDOGREL Drug: ROSUVASTATIN
40 mg before procedure
Experimental: ROSUVASTATIN Drug: ROSUVASTATIN
40 mg before procedure


Outcome Measures

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

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

Eligibility Criteria

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): NCT01007279


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

Responsible Party: GENNARO SARDELLA, POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME
ClinicalTrials.gov 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:
Necrosis
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors