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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by General Hospital of Chinese Armed Police Forces.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:
NCT01334671
First received: March 30, 2011
Last updated: April 12, 2011
Last verified: April 2011
History of Changes
  Purpose

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


Condition Intervention Phase
ST-elevation Myocardial Infarction
(STEMI)
 Drug: Atorvastatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Clinical Effect of Intensive Statin Therapy in STEMI(ST-elevated Myocardial Infarction) Patients Before Emergency PCI(Percutaneous Coronary Intervention)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by General Hospital of Chinese Armed Police Forces:

Primary Outcome Measures:
  • MACEs (Major adverse cardiac events) [ Time Frame: follow-up for 6 months ] [ Designated as safety issue: Yes ]
    MACEs were compared among three groups during follow-up in STEMI patients undergoing emergency PCI.


Secondary Outcome Measures:
  • Echocardiographic changes [ Time Frame: postoperative 6 month ] [ Designated as safety issue: Yes ]
    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

  • HS-CRP,NO,SAA values [ Time Frame: preoperation 1 hour,postoperative 24 and 72 hours,postoperative 7 days ] [ Designated as safety issue: Yes ]
    to compare hs-crp,no,saa values at differnt treatment period among three groups

  • CK,CK-MB [ Time Frame: preoperation 1hour,postoperation 4/8/12/16/20/24hours ] [ Designated as safety issue: Yes ]
    to estimate myocardial damage degree among three groups

  • AST(glutamic-oxalacetic transaminease ),ALT(glutamic-pyruvic transaminase),LDL(low density lipoprotein cholesterin),TG(triglyceride) [ Time Frame: preoperation 1 hour,postoperation 24 and 72hours,postoperation 7 days ] [ Designated as safety issue: Yes ]
    to monitor adverse drug reaction


Estimated Enrollment: 150
Study Start Date: February 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1, Atorvastatin
STEMI 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
 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
Other Name: lipitol
Experimental: group 2 , Atorvastatin
Group 2 will be administered with atorvastatin 40mg per day for one month,then 20mg per day until the end of the trial
 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
Other Name: lipitol
Experimental: group 3 , Atorvastatin
Group 3 will be administered with atorvastatin 20mg per day until the end of the trial
 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
Other Name: lipitol

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334671

Contacts
Contact: HuiLiang LIU, Doctor 86-10-57976531 lhl518@vip.sina.com
Contact: Yong Yang, Doctor 86-10-57976533 yangyongfmmu@yahoo.com.cn

Locations
China
General Hospital of Chinese People's Armed Police Forces Recruiting
BeiJing, China, 100039
Contact: HuiIiang Liu, Doctor     86-10-57976531     lhl518@vip.sina.com    
Contact: Yong Yang, Doctor     86-10-57976533     672862837@qq.com;yangyongfmmu@yahoo.com.cn    
Principal Investigator: HuiLiang Liu, Doctor            
Principal Investigator: Yong Yang, Doctors            
Principal Investigator: Wenwen Yuan, Master            
Sponsors and Collaborators
General Hospital of Chinese Armed Police Forces
Investigators
Principal Investigator: HuiLiang Liu, Doctor Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
ClinicalTrials.gov Identifier: NCT01334671     History of Changes
Other Study ID Numbers: W2-2009041
Study First Received: March 30, 2011
Last Updated: April 12, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by General Hospital of Chinese Armed Police Forces:
ST-elevation myocardial infarction(STEMI)
emergency percutaneous coronary intervention(PCI)
lipitor or Atorvastatin

Additional relevant MeSH terms:
Emergencies
Infarction
Myocardial Infarction
Disease Attributes
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013