Back to resultsROsuvastatin Pretreatment to Reduce MyocArdial Periprocedural Necrosis:Comparison With Atorvastatin Reloading (ROMAIIReload)
Primary Purpose
Assess the Periprocedural Myocardial Necrosis
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
ATORVASTATIN 80 mg
ROSUVASTATIN 40 mg
Sponsored by
About this trial
This is an interventional treatment trial for Assess the Periprocedural Myocardial Necrosis focused on measuring Myonecrosis, 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
ROSUVASTATIN
ATORVASTATIN
Arm Description
Outcomes
Primary Outcome Measures
Myocardial enzymes arise
Secondary Outcome Measures
MACCE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01228227
Brief Title
ROsuvastatin Pretreatment to Reduce MyocArdial Periprocedural Necrosis:Comparison With Atorvastatin Reloading
Acronym
ROMAIIReload
Official Title
High Loading ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis : Comparison With Atorvastatin High Dose Reloading.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gennaro Sardella
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 clopidogrel loading dose administration before procedure.(8,9)The investigators compared a high (80mg) re-loading dose of Atorvastatin with a high loading dose of Rosuvastatin (40 mg) both administered within 24h before the procedure in reducing the rate of periprocedural MI. Therefore, the investigators will conduct a single center, prospective randomized study to assess whether a single, high (80mg) loading (within 24h)dose of Atorvastatin compared with a single loading dose of Rosuvastatin (20 mg) is effective in preventing elevation of biomarkers of MI after elective coronary stent implantation. We evaluate the incidence of MACCE(occurring of cardiac death, myocardial infarction (including periprocedural myonecrosis) and stroke at 30 days 6 and 12 month follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Assess the Periprocedural Myocardial Necrosis
Keywords
Myonecrosis, 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
310 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ROSUVASTATIN
Arm Type
Active Comparator
Arm Title
ATORVASTATIN
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ATORVASTATIN 80 mg
Intervention Description
reload of Atorvastatin 80 mg before the procedure
Intervention Type
Drug
Intervention Name(s)
ROSUVASTATIN 40 mg
Intervention Description
reload of rosuvastatin 40 mg before the procedure
Primary Outcome Measure Information:
Title
Myocardial enzymes arise
Time Frame
12- 24 hours
Secondary Outcome Measure Information:
Title
MACCE
Time Frame
1-6-12 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
Roma
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
ROsuvastatin Pretreatment to Reduce MyocArdial Periprocedural Necrosis:Comparison With Atorvastatin Reloading
We'll reach out to this number within 24 hrs