ROsuvastatin Pretreatment to Reduce MyocArdial Periprocedural Necrosis:Comparison With Atorvastatin Reloading

Study Overview
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Brief Summary
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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.

Official Title
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High Loading ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis : Comparison With Atorvastatin High Dose Reloading.

Conditions
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Assess the Periprocedural Myocardial Necrosis

Intervention / Treatment
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* Drug: ATORVASTATIN 80 mg
* Drug: ROSUVASTATIN 40 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stable angina Exclusion Criteria: Baseline myocardial enzyme rise

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ROSUVASTATIN<br> | Drug: ROSUVASTATIN 40 mg<br>* reload of rosuvastatin 40 mg before the procedure<br>|
| Experimental: ATORVASTATIN<br> | Drug: ATORVASTATIN 80 mg<br>* reload of Atorvastatin 80 mg before the procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial enzymes arise |  | 12- 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE |  | 1-6-12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myonecrosis, Percutaneous Angioplasty, Myocardial Infarction