Rosuvastatin in Preventing Myonecrosis in Elective Percutaneous Coronary Interventions (PCIs)
ROMA
ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2010
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2009
CompletedFirst Posted
Study publicly available on registry
November 4, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedOctober 26, 2010
March 1, 2010
6 months
November 3, 2009
October 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myocardial enzymes arise
6-12-24 hours
Secondary Outcomes (1)
MACE
1-6-9 MONTHS
Study Arms (2)
CLOPIDOGREL
ACTIVE COMPARATORROSUVASTATIN
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients with stable angina
You may not qualify if:
- Baseline myocardial enzyme rise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico Umberto I
Rome, 00166, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 3, 2009
First Posted
November 4, 2009
Study Start
March 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
October 26, 2010
Record last verified: 2010-03