Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome

Study Overview
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Brief Summary
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This present study is specifically designed to examine the efficacy and safety of a high pre-treatment dose of atorvastatin in Asian patients with NSTE-ACS in China and the Republic of Korea, by using a treatment paradigm similar to that employed in the ARMYDA-ACS study.

Official Title
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A Prospective Randomized, Open-Label, Parallel-Group Comparative Study: Atorvastatin Pre-Treatment Versus Usual Care In Asian Patients With Acute Coronary Syndromes Undergoing Early Percutaneous Coronary Intervention

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-ST elevated ACS; LDL-C > 80 mg/dl Exclusion Criteria: ST elevated acute myocardial infarction; previously or currently treated with atorvastatin or other statins

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin Group<br> | Drug: Atorvastatin<br>* 80mg 12 hours pre-Percutaneous Coronary Intervention (PCI), 40mg 2 hours pre-PCI and 40mg daily after PCI for 30 days.<br>|
| Other: Usual Care Group<br> | Drug: Atorvastatin<br>* 40mg daily after PCI for 30 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI) | Percentage calculated as: (number of participants who experienced MACE [death, myocardial infarction, target vessel revascularization] within 30 days post-PCI) divided by (number of participants who experienced PCI) * 100. Major Adverse Cardiac Events (MACE) that occurred after 33 days post PCI were excluded. | 30 days post PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI | Percentage calculated as: (number of participants who experienced MACE within 8 hours post-PCI) divided by (number of participants who experienced PCI) * 100. | 8 hours post PCI | 
| Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI | Percentage calculated as: (number of participants who experienced MACE within 24 hours post PCI) divided by (number of participants who experienced PCI) * 100. | 24 hours post PCI | 
| Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB) | CK-MB above the upper limit of normal range from baseline (biomarker of myocardial injury); normal range: 0-5.0 nanograms per milliliter (ng/mL). | 8 hours, 24 hours and 30 days post PCI | 
| Percentage of Participants With Elevated Troponin I | Troponin I above the upper limit of normal range from baseline (biomarker of myocardial injury): normal range: 0-0.5 nanograms per milliliter (ng/mL). | 8 hours, 24 hours and 30 days post PCI | 
| Percentage of Participants With Elevated Myoglobin | Myoglobin above the upper limit of normal from baseline (biomarker of myocardial injury): normal range: 0-109 nanograms per milliliter (ng/mL). | 8 hours, 24 hours and 30 days post PCI | 
| Percent Change From Baseline in C-Reactive Protein (CRP) | C-reactive protein percent change from baseline = (post baseline value minus baseline value) divided by baseline value*100. Includes all CRP samples tested for the study, including samples unaffected and those samples affected by defective high-sensitivity (hs) CRP reagents. | Baseline, 8 hours, 24 hours and 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asia Lipitor Pre-treatment in Acute Coronary Syndrome