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
Overview
- Phase
- Phase 4
- Intervention
- Atorvastatin
- Conditions
- Acute Coronary Syndrome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Enrollment
- 499
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Atorvastatin Group
Intervention: Atorvastatin
Usual Care Group
Intervention: Atorvastatin
Outcomes
Primary Outcomes
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI)
Time Frame: 30 days post 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.
Secondary Outcomes
- Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB)(8 hours, 24 hours and 30 days post PCI)
- Percentage of Participants With Elevated Myoglobin(8 hours, 24 hours and 30 days post PCI)
- Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI(8 hours post PCI)
- Percentage of Participants With Elevated Troponin I(8 hours, 24 hours and 30 days post PCI)
- Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI(24 hours post PCI)
- Percent Change From Baseline in C-Reactive Protein (CRP)(Baseline, 8 hours, 24 hours and 30 days)