The Clinical Effect of Intensive Statin Therapy in STEMI Patients Before Emergency PCI
1 other identifier
interventional
150
1 country
1
Brief Summary
The purpose of this study is to evaluate the clinical effect of intensive statin therapy before emergency PCI in patients with STEMI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 30, 2011
CompletedFirst Posted
Study publicly available on registry
April 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedApril 13, 2011
April 1, 2011
1.8 years
March 30, 2011
April 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MACEs (Major adverse cardiac events)
MACEs were compared among three groups during follow-up in STEMI patients undergoing emergency PCI.
follow-up for 6 months
Secondary Outcomes (4)
Echocardiographic changes
postoperative 6 month
HS-CRP,NO,SAA values
preoperation 1 hour,postoperative 24 and 72 hours,postoperative 7 days
CK,CK-MB
preoperation 1hour,postoperation 4/8/12/16/20/24hours
AST(glutamic-oxalacetic transaminease ),ALT(glutamic-pyruvic transaminase),LDL(low density lipoprotein cholesterin),TG(triglyceride)
preoperation 1 hour,postoperation 24 and 72hours,postoperation 7 days
Study Arms (3)
group 1, Atorvastatin
EXPERIMENTALSTEMI patients will be randomly divided into three groups Group 1 which has been give 80mg atorvastatin before PCI will be administered with atorvastatin 40mg per day for one month,then 20mg per day until the end of the trial
group 2 , Atorvastatin
EXPERIMENTALGroup 2 will be administered with atorvastatin 40mg per day for one month,then 20mg per day until the end of the trial
group 3 , Atorvastatin
EXPERIMENTALGroup 3 will be administered with atorvastatin 20mg per day until the end of the trial
Interventions
Group 1:80mg before PCI and 40mg per day after PCI for one month then 20mg per day until the end of the trial Group 2:40mg per day after PCI for one month then 20mg per day until the end of the trial Group 3:20mg per day after PCI until the end of the trial
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of STEMI less than 12 hours 2.Eligible for emergency PCI
You may not qualify if:
- Contradiction to atorvastatin 2.Contradiction to aspirin, clopidogrel and contrast medium 3.Life expectancy less than 3 months 4.Tumor or inflammatory diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Hospital of Chinese People's Armed Police Forces
Beijing, 100039, China
Related Publications (8)
Walter DH, Dimmeler S, Zeiher AM. Effects of statins on endothelium and endothelial progenitor cell recruitment. Semin Vasc Med. 2004 Nov;4(4):385-93. doi: 10.1055/s-2004-869595.
PMID: 15861319RESULTWilson AM, Ryan MC, Boyle AJ. The novel role of C-reactive protein in cardiovascular disease: risk marker or pathogen. Int J Cardiol. 2006 Jan 26;106(3):291-7. doi: 10.1016/j.ijcard.2005.01.068.
PMID: 16337036RESULTKatayama T，Nakashima H，Yonekura T，et al. Significance of acutephase inflammatory reactants as an indicator of prognosis after acute myocardial infarction：which is the most useful predictor？J Cardiol，2003
RESULTTopol EJ. Intensive statin therapy--a sea change in cardiovascular prevention. N Engl J Med. 2004 Apr 8;350(15):1562-4. doi: 10.1056/NEJMe048061. Epub 2004 Mar 8. No abstract available.
PMID: 15007111RESULTAlbrecht C，KaePPel N，Gauglitz G.Twoimmunoassay formats for fully automated CRPdetection in human serum【J」Anal Bioanal Chem，2008， 391(5):1845一1852.
RESULTWu TL, I Chen Tsai, Chang PY, Tsao KC, Sun CF, Wu LL, Wu JT. Establishment of an in-house ELISA and the reference range for serum amyloid A (SAA): complementarity between SAA and C-reactive protein as markers of inflammation. Clin Chim Acta. 2007 Feb;376(1-2):72-6. doi: 10.1016/j.cca.2006.07.012. Epub 2006 Jul 15.
PMID: 16916504RESULTAntoniades C, Tousoulis D, Vasiliadou C, Pitsavos C, Chrysochoou C, Panagiotakos D, Tentolouris C, Marinou K, Koumallos N, Stefanadis C. Genetic polymorphism on endothelial nitric oxide synthase affects endothelial activation and inflammatory response during the acute phase of myocardial infarction. J Am Coll Cardiol. 2005 Sep 20;46(6):1101-9. doi: 10.1016/j.jacc.2005.05.072.
PMID: 16168297RESULTLiu HL, Yang Y, Yang SL, Luo JP, Li H, Jing LM, Shen ZQ. Administration of a loading dose of atorvastatin before percutaneous coronary intervention prevents inflammation and reduces myocardial injury in STEMI patients: a randomized clinical study. Clin Ther. 2013 Mar;35(3):261-72. doi: 10.1016/j.clinthera.2013.01.009. Epub 2013 Feb 12.
PMID: 23410871DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
HuiLiang Liu, Doctor
Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 30, 2011
First Posted
April 13, 2011
Study Start
February 1, 2011
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
April 13, 2011
Record last verified: 2011-04