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

February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

499

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Pfizer Investigational Site
      • Beijing, China, 100034
        • Pfizer Investigational Site
      • Beijing, China, 100029
        • Pfizer Investigational Site
      • Shanghai, China, 200032
        • Pfizer Investigational Site
      • Shanghai, China, 200127
        • Pfizer Investigational Site
      • Shanghai, China, 200233
        • Pfizer Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510100
        • Pfizer Investigational Site
    • Hunan
      • Changsha, Hunan, China, 410008
        • Pfizer Investigational Site
    • Liaoning
      • Shen Yang, Liaoning, China, 110016
        • Pfizer Investigational Site
      • Shenyang, Liaoning, China, 110004
        • Pfizer Investigational Site
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Pfizer Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Pfizer Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Pfizer Investigational Site
      • Daegu, Korea, Republic of, 705-718
        • Pfizer Investigational Site
      • Daegu, Korea, Republic of, 705-717
        • Pfizer Investigational Site
      • Daegu, Korea, Republic of
        • Pfizer Investigational Site
      • Daejeon, Korea, Republic of, 301-721,
        • Pfizer Investigational Site
      • Gangneung-si, Gangwon-do, Korea, Republic of, 210-711
        • Pfizer Investigational Site
      • Gwang Ju, Korea, Republic of, 501-757
        • Pfizer Investigational Site
      • Jinju-si, Gyeongsangnam-do, Korea, Republic of, 660-702
        • Pfizer Investigational Site
      • Koyang-shi, Korea, Republic of, 410-719
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 152-703
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 130-702
        • Pfizer Investigational Site
      • Ulsan, Korea, Republic of, 682-714
        • Pfizer Investigational Site
    • Gyeonggi-do, Korea
      • Seongnam-si, Gyeonggi-do, Korea, Korea, Republic of, 463-707
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

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)
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.
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
Time Frame: 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
Time Frame: 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)
Time Frame: 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).
8 hours, 24 hours and 30 days post PCI
Percentage of Participants With Elevated Troponin I
Time Frame: 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).
8 hours, 24 hours and 30 days post PCI
Percentage of Participants With Elevated Myoglobin
Time Frame: 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).
8 hours, 24 hours and 30 days post PCI
Percent Change From Baseline in C-Reactive Protein (CRP)
Time Frame: 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.
Baseline, 8 hours, 24 hours and 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

July 31, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (Estimate)

August 6, 2008

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2581161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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