Back to resultsRosuvastatin in Preventing Myonecrosis in Elective Percutaneous Coronary Interventions (PCIs) (ROMA)
Primary Purpose
Periprocedural Myocardial Necrosis
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
ROSUVASTATIN
Sponsored by
About this trial
This is an interventional treatment trial for Periprocedural Myocardial Necrosis focused on measuring Percutaneous angioplasty, Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- Patients with stable angina
Exclusion Criteria:
- Baseline myocardial enzyme rise
Sites / Locations
- Policlinico Umberto I
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CLOPIDOGREL
ROSUVASTATIN
Arm Description
Outcomes
Primary Outcome Measures
Myocardial enzymes arise
Secondary Outcome Measures
MACE
Full Information
NCT ID
NCT01007279
First Posted
November 3, 2009
Last Updated
October 25, 2010
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT01007279
Brief Title
Rosuvastatin in Preventing Myonecrosis in Elective Percutaneous Coronary Interventions (PCIs)
Acronym
ROMA
Official Title
ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periprocedural Myocardial Necrosis
Keywords
Percutaneous angioplasty, Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CLOPIDOGREL
Arm Type
Active Comparator
Arm Title
ROSUVASTATIN
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ROSUVASTATIN
Intervention Description
40 mg before procedure
Primary Outcome Measure Information:
Title
Myocardial enzymes arise
Time Frame
6-12-24 hours
Secondary Outcome Measure Information:
Title
MACE
Time Frame
1-6-9 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with stable angina
Exclusion Criteria:
Baseline myocardial enzyme rise
Facility Information:
Facility Name
Policlinico Umberto I
City
Rome
ZIP/Postal Code
00166
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Rosuvastatin in Preventing Myonecrosis in Elective Percutaneous Coronary Interventions (PCIs)
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