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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00728988
First received: July 31, 2008
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 hours post PCI ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 hours post PCI ] [ Designated as safety issue: No ]
    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) [ Time Frame: 8 hours, 24 hours and 30 days post PCI ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 hours, 24 hours and 30 days post PCI ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 hours, 24 hours and 30 days post PCI ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 8 hours, 24 hours and 30 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 499
Study Start Date: September 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Usual Care Group Drug: Atorvastatin
40mg daily after PCI for 30 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728988

Locations
China, Guangdong
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510100
China, Hunan
Pfizer Investigational Site
Changsha, Hunan, China, 410008
China, Liaoning
Pfizer Investigational Site
Shen Yang, Liaoning, China, 110016
Pfizer Investigational Site
Shenyang, Liaoning, China, 110004
China, Shandong
Pfizer Investigational Site
Qingdao, Shandong, China, 266000
China, Zhejiang
Pfizer Investigational Site
Hangzhou, Zhejiang, China, 310016
China
Pfizer Investigational Site
Beijing, China, 100730
Pfizer Investigational Site
Beijing, China, 100034
Pfizer Investigational Site
Beijing, China, 100029
Pfizer Investigational Site
Shanghai, China, 200233
Pfizer Investigational Site
Shanghai, China, 200127
Pfizer Investigational Site
Shanghai, China, 200032
Korea, Republic of
Pfizer Investigational Site
Seongnam-si, Gyeonggi-do, Korea, Korea, Republic of, 463-707
Pfizer Investigational Site
Busan, Korea, Republic of, 602-715
Pfizer Investigational Site
Daegu, Korea, Republic of, 705-717
Pfizer Investigational Site
Daegu, Korea, Republic of, 705-718
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
Pfizer Investigational Site
Seoul, Korea, Republic of, 130-702
Pfizer Investigational Site
Seoul, Korea, Republic of, 152-703
Pfizer Investigational Site
Ulsan, Korea, Republic of, 682-714
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00728988     History of Changes
Other Study ID Numbers: A2581161
Study First Received: July 31, 2008
Results First Received: April 25, 2011
Last Updated: September 29, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Pfizer:
Asia Lipitor Pre-treatment in Acute Coronary Syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014