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

This study has been completed.
Sponsor:
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01007279
First received: November 3, 2009
Last updated: October 25, 2010
Last verified: March 2010
  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 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 Intervention Phase
Periprocedural Myocardial Necrosis
Drug: ROSUVASTATIN
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Myocardial enzymes arise [ Time Frame: 6-12-24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • MACE [ Time Frame: 1-6-9 MONTHS ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CLOPIDOGREL Drug: ROSUVASTATIN
40 mg before procedure
Experimental: ROSUVASTATIN Drug: ROSUVASTATIN
40 mg before procedure

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with stable angina

Exclusion Criteria:

  • Baseline myocardial enzyme rise
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007279

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

No publications provided

Responsible Party: GENNARO SARDELLA, POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME
ClinicalTrials.gov Identifier: NCT01007279     History of Changes
Other Study ID Numbers: ROMA55
Study First Received: November 3, 2009
Last Updated: October 25, 2010
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 17, 2014