The Clinical Effect of Intensive Statin Therapy in STEMI Patients Before Emergency PCI

ST-elevation Myocardial Infarction Clinical Trial

Official title:

The Clinical Effect of Intensive Statin Therapy in STEMI(ST-elevated Myocardial Infarction) Patients Before Emergency PCI(Percutaneous Coronary Intervention)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01334671
• Other study ID #: W2-2009041
• Status: Recruiting
• Phase: Phase 3
• First received: March 30, 2011
• Last updated: April 12, 2011
• Start date: February 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2011
• Source: General Hospital of Chinese Armed Police Forces
• Contact: HuiLiang LIU, Doctor
• Phone: 86-10-57976531
• Email: lhl518[@]vip.sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical effect of intensive statin therapy before emergency PCI in patients with STEMI.

Description:

150 STEMI patients planned for emergency PCI were randomized to three groups, Group 1:received atorvastatin 80-mg loading dose before PCI then followed by 40-mg daily for one month and a maintenance dose of 20-mg qd thereafter(n=50); Group 2:received atorvastatin 40-mg qd after PCI for one month and a maintenance dose of 20-mg qd thereafter(n=50); Group 3: received atorvastatin 20-mg qd after PCI (n=50).Before PCI,all subjects received oral administration of aspirin 300mg and clopidogrel 300mg.Levels of creatine kinase,CK-MB(creatine kinase-MB),were measured to estimate myocardial damage degree.HS-CRP(high sensitivity C -reactive protein),NO(NO synthase),SAA(Serum amyloid A) were measured at preoperation 1 hour,postoperative 24 and 72 hours,7days after PCI. To compare echocardiography changes among three groups.Patients enrolled in the study need to receive follow-up survey which was carried out by clinical doctors.Hence,MACEs were analyzed during 6-month follow-up.So, the aim of our study is to evaluate the clinical significance of loading dosage of atorvastatin therapy and analyze the mechanism underlying it.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1.Clinical diagnosis of STEMI less than 12 hours 2.Eligible for emergency PCI

Exclusion Criteria:

• 1.Contradiction to atorvastatin 2.Contradiction to aspirin, clopidogrel and contrast medium 3.Life expectancy less than 3 months 4.Tumor or inflammatory diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• (STEMI)
• Emergencies
• Infarction
• Myocardial Infarction
• ST-elevation Myocardial Infarction

Intervention

Drug:
• Atorvastatin
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

Locations

Country	Name	City	State
China	General Hospital of Chinese People's Armed Police Forces	BeiJing

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Chinese Armed Police Forces

Country where clinical trial is conducted

China, 

References & Publications (7)

Albrecht C, Kaeppel N, Gauglitz G. Two immunoassay formats for fully automated CRP detection in human serum. Anal Bioanal Chem. 2008 Jul;391(5):1845-52. doi: 10.1007/s00216-008-2093-x. Epub 2008 May 3. — View Citation

Antoniades 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 dur — View Citation

Katayama T, Nakashima H, Yonekura T, Honda Y, Suzuki S, Yano K. [Significance of acute-phase inflammatory reactants as an indicator of prognosis after acute myocardial infarction: which is the most useful predictor?]. J Cardiol. 2003 Aug;42(2):49-56. Japa — View Citation

Topol EJ. Intensive statin therapy--a sea change in cardiovascular prevention. N Engl J Med. 2004 Apr 8;350(15):1562-4. Epub 2004 Mar 8. — View Citation

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. Review. — View Citation

Wilson 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. Review. — View Citation

Wu 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Echocardiographic changes	to compare echocardiographic changes ( left ventricular ejection fraction(LVEF); Left Ventricular Internal Diameter diastolic(LVIDd);Left Ventricular Internal Diameter systolic (LVIDs),Left Ventricular Enddiastolic Volume(LVEDV);Left Ventricular Endsystolic Volume(LVESV)at postoperative 6 month among three groups	postoperative 6 month	Yes
Secondary	HS-CRP,NO,SAA values	to compare hs-crp,no,saa values at differnt treatment period among three groups	preoperation 1 hour,postoperative 24 and 72 hours,postoperative 7 days	Yes
Secondary	CK,CK-MB	to estimate myocardial damage degree among three groups	preoperation 1hour,postoperation 4/8/12/16/20/24hours	Yes
Secondary	AST(glutamic-oxalacetic transaminease ),ALT(glutamic-pyruvic transaminase),LDL(low density lipoprotein cholesterin),TG(triglyceride)	to monitor adverse drug reaction	preoperation 1 hour,postoperation 24 and 72hours,postoperation 7 days	Yes