Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome
NCT00728988
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Acute Coronary Syndrome
Sex
Females and Males
Age
18 + years
Inclusion Criteria
Show details
- Non-ST elevated ACS; LDL-C > 80 mg/dl
Exclusion Criteria
Show details
- ST elevated acute myocardial infarction; previously or currently treated with
atorvastatin or other statins
NEED INFO?
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ALL GENDERS
18 Years+
years
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Acute Coronary SyndromeA Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients
NCT00852397
- Kasuga, Fukuoka
- Kitakyusyu, Fukuoka
- Kure, Hiroshima
- Sapporo, Hokkaido
- Uji, Kyoto
- Ikoma, Nara
- Hirakata, Osaka
- Kawachinagano, Osaka
- Matsubara, Osaka
- Yao, Osaka
- Wako, Saitama
- Sunto, Shizuoka
- Minato-Ku, Tokyo
- Shinagawa, Tokyo
- Gifu,
- Hiroshima,
- Kumamoto,
- Osaka,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Acute Coronary SyndromeEffectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice
NCT00922766
- Ahmedabad, Gujarat
- Surat, Gujarat
- Hissar, Haryana
- Hissar, Haryana
- Bangalore, Karnataka
- Manglore, Karnataka
- Mysore, Karnataka
- Nagpur, Maharahtra
- Nashik, Maharahtra
- Ambernath (E), Maharashtra
- Nagpur, Maharashtra
- Nagpur, Maharashtra
- Nagpur, Maharashtra
- Nagpur, Maharashtra
- Nashik Road, Maharashtra
- Nashik Road, Maharashtra
- Nashik, Maharashtra
- Nashik, Maharashtra
- Thane, Maharashtra
- Bikaner, Rajasthan
- Jaipur, Rajasthan
- Jaipur, Rajasthan
- Chennai, Tamil Nadu
- Kolkata, West Bengal
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Acute Coronary SyndromeAtorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome
NCT00728988
- Guangzhou, Guangdong
- Changsha, Hunan
- Shen Yang, Liaoning
- Shenyang, Liaoning
- Qingdao, Shandong
- Hangzhou, Zhejiang
- Beijing,
- Beijing,
- Beijing,
- Shanghai,
- Shanghai,
- Shanghai,
- Seongnam-si, Gyeonggi-do, Korea
- Busan,
- Daegu,
- Daegu,
- Daegu,
- Daejeon,
- Gangneung-si, Gangwon-do,
- Gwang Ju,
- Jinju-si, Gyeongsangnam-do,
- Koyang-shi,
- Seoul,
- Seoul,
- Seoul,
- Ulsan,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 499 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |