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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Atorvastatin
Atorvastatin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring Asia Lipitor Pre-treatment in Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Atorvastatin Group

Usual Care Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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).
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).
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.

Full Information

First Posted
July 31, 2008
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00728988
Brief Title
Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome
Acronym
ALPACS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Asia Lipitor Pre-treatment in Acute Coronary Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
499 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin Group
Arm Type
Experimental
Arm Title
Usual Care Group
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
80mg 12 hours pre-Percutaneous Coronary Intervention (PCI), 40mg 2 hours pre-PCI and 40mg daily after PCI for 30 days.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
40mg daily after PCI for 30 days.
Primary Outcome Measure Information:
Title
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI)
Description
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.
Time Frame
30 days post PCI
Secondary Outcome Measure Information:
Title
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI
Description
Percentage calculated as: (number of participants who experienced MACE within 8 hours post-PCI) divided by (number of participants who experienced PCI) * 100.
Time Frame
8 hours post PCI
Title
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI
Description
Percentage calculated as: (number of participants who experienced MACE within 24 hours post PCI) divided by (number of participants who experienced PCI) * 100.
Time Frame
24 hours post PCI
Title
Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB)
Description
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).
Time Frame
8 hours, 24 hours and 30 days post PCI
Title
Percentage of Participants With Elevated Troponin I
Description
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).
Time Frame
8 hours, 24 hours and 30 days post PCI
Title
Percentage of Participants With Elevated Myoglobin
Description
Myoglobin above the upper limit of normal from baseline (biomarker of myocardial injury): normal range: 0-109 nanograms per milliliter (ng/mL).
Time Frame
8 hours, 24 hours and 30 days post PCI
Title
Percent Change From Baseline in C-Reactive Protein (CRP)
Description
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.
Time Frame
Baseline, 8 hours, 24 hours and 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510100
Country
China
Facility Name
Pfizer Investigational Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Pfizer Investigational Site
City
Shen Yang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
Pfizer Investigational Site
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Pfizer Investigational Site
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Facility Name
Pfizer Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
Pfizer Investigational Site
City
Seongnam-si
State/Province
Gyeonggi-do, Korea
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Daegu
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Daejeon
ZIP/Postal Code
301-721,
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Gangneung-si, Gangwon-do
ZIP/Postal Code
210-711
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Gwang Ju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Jinju-si, Gyeongsangnam-do
ZIP/Postal Code
660-702
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Koyang-shi
ZIP/Postal Code
410-719
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Ulsan
ZIP/Postal Code
682-714
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24216317
Citation
Jang Y, Zhu J, Ge J, Kim YJ, Ji C, Lam W. Preloading with atorvastatin before percutaneous coronary intervention in statin-naive Asian patients with non-ST elevation acute coronary syndromes: A randomized study. J Cardiol. 2014 May;63(5):335-43. doi: 10.1016/j.jjcc.2013.09.012. Epub 2013 Nov 9.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581161&StudyName=Atorvastatin%20Pre-Treatment%20Study%20In%20Asian%20Patients%20With%20Acute%20Coronary%20Syndrome
Description
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Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome

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