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

NCT00728988

Last updated date
Study Location
Pfizer Investigational Site
Guangzhou, Guangdong, 510100, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Coronary Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Non-ST elevated ACS; LDL-C > 80 mg/dl

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- ST elevated acute myocardial infarction; previously or currently treated with
atorvastatin or other statins

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Advanced Information
Descriptive Information
Brief Title  ICMJE Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Atorvastatin Group
    Intervention: Drug: Atorvastatin
  • Usual Care Group
    Intervention: Drug: Atorvastatin
Publications * Jang Y, Zhu J, Ge J, Kim YJ, Ji C, Lam W. Preloading with atorvastatin before percutaneous coronary intervention in statin-naïve 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2010)
499
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2008)
350
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00728988
Other Study ID Numbers  ICMJE A2581161
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP