Phase 4
N=499
Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00728988 ↗Enrolled (actual)
499
Serious AEs
6.5%
Results posted
Sep 2011
Primary outcome: Primary: Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI) — 14.7; 15.7; 0.6; 0.6 percentage of participants — p=0.9237
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atorvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI) |
14.7; 15.7; 0.6; 0.6; 14.1; 15.1 | 0.9237 |
| SECONDARY Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI |
6.7; 6.4 | 1.0000 |
| SECONDARY Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI |
13.5; 15.1 | 0.7896 |
| SECONDARY Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB) |
11.3; 13.6; 15.6; 18.9; 1.3; 0.0 | 0.631 |
| SECONDARY Percentage of Participants With Elevated Troponin I |
40.4; 35.5; 49.7; 44.4; 1.9; 1.8 | 0.425 |
| SECONDARY Percentage of Participants With Elevated Myoglobin |
8.2; 10.8; 3.1; 4.2; 1.3; 0.6 | 0.529 |
| SECONDARY Percent Change From Baseline in C-Reactive Protein (CRP) |
205.25; 234.77; 594.07; 543.50; 9.01; 67.23 | 0.7554 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00728988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.