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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective Randomized, Open-Label, Parallel-Group Comparative Study: Atorvastatin Pre-Treatment Versus Usual Care In Asian Patients With Acute Coronary Syndromes Underg

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 Summary:
Sponsor: Pfizer

Current Primary Outcome: 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.


Original Primary Outcome: Incidence of Major Adverse Cardiac Event (MACE) (death, myocardial infarction, target vessel revascularization) [ Time Frame: 30 days post PCI ]

Current Secondary Outcome:

  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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.


Original Secondary Outcome:

  • Safety and tolerability profile of atorvastatin [ Time Frame: 30 days after PCI ]
  • Incidence of MACE [ Time Frame: 8 hours and 24 hours post PCI ]
  • Proportion of patients who have any elevated biomarkers of myocardial injury above normal range [ Time Frame: 8 hours, 24 hours and 30 days post PCI ]
  • Change from baseline in C-Reactive Protein (CRP) [ Time Frame: 8 hours, 24 hours and 30 days ]


Information By: Pfizer

Dates:
Date Received: July 31, 2008
Date Started: September 2008
Date Completion:
Last Updated: September 29, 2011
Last Verified: September 2011