Clinical trial NCT00728988: Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: Asia Lipitor Pre-treatment in Acute Coronary Syndrome
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-06
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI)
timeFrame: 30 days post PCI
Secondary outcomes:
measure: Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI
timeFrame: 8 hours post PCI
measure: Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI
timeFrame: 24 hours post PCI
measure: Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB)
timeFrame: 8 hours, 24 hours and 30 days post PCI
measure: Percentage of Participants With Elevated Troponin I
timeFrame: 8 hours, 24 hours and 30 days post PCI
measure: Percentage of Participants With Elevated Myoglobin
timeFrame: 8 hours, 24 hours and 30 days post PCI
measure: Percent Change From Baseline in C-Reactive Protein (CRP)
timeFrame: Baseline, 8 hours, 24 hours and 30 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Changsha
country: China
facility: Pfizer Investigational Site
state: Hunan
city: Shen Yang
country: China
facility: Pfizer Investigational Site
state: Liaoning
city: Shenyang
country: China
facility: Pfizer Investigational Site
state: Liaoning
city: Qingdao
country: China
facility: Pfizer Investigational Site
state: Shandong
city: Hangzhou
country: China
facility: Pfizer Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Seongnam-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do, Korea
city: Busan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Gangneung-si, Gangwon-do
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Gwang Ju
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Jinju-si, Gyeongsangnam-do
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Koyang-shi
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Ulsan
country: Korea, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.