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

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Atorvastatin

• Registration Number: NCT00728988
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-08-05
• Study First Posted: 2008-08-06
• Study Start: 2008-09
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-04-25
• Results First Submitted QC: 2011-08-19
• Results First Posted: 2011-09-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 499

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin Group	Atorvastatin	-
Usual Care Group	Atorvastatin	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI)	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 Outcome Measures

Name	Time	Method
Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB)	8 hours, 24 hours and 30 days post PCI	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).
Percentage of Participants With Elevated Myoglobin	8 hours, 24 hours and 30 days post PCI	Myoglobin above the upper limit of normal from baseline (biomarker of myocardial injury): normal range: 0-109 nanograms per milliliter (ng/mL).
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI	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.
Percentage of Participants With Elevated Troponin I	8 hours, 24 hours and 30 days post PCI	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).
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI	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.
Percent Change From Baseline in C-Reactive Protein (CRP)	Baseline, 8 hours, 24 hours and 30 days	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇰🇷 Ulsan, Korea, Republic of