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

Primary Purpose

ST-elevation Myocardial Infarction, (STEMI)

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
General Hospital of Chinese Armed Police Forces
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-elevation Myocardial Infarction focused on measuring ST-elevation myocardial infarction(STEMI), emergency percutaneous coronary intervention(PCI), lipitor or Atorvastatin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of Chinese People's Armed Police ForcesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

group 1, Atorvastatin

group 2 , Atorvastatin

group 3 , Atorvastatin

Arm Description

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

Group 2 will be administered with atorvastatin 40mg per day for one month,then 20mg per day until the end of the trial

Group 3 will be administered with atorvastatin 20mg per day until the end of the trial

Outcomes

Primary Outcome Measures

MACEs (Major adverse cardiac events)
MACEs were compared among three groups during follow-up in STEMI patients undergoing emergency PCI.

Secondary Outcome Measures

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
HS-CRP,NO,SAA values
to compare hs-crp,no,saa values at differnt treatment period among three groups
CK,CK-MB
to estimate myocardial damage degree among three groups
AST(glutamic-oxalacetic transaminease ),ALT(glutamic-pyruvic transaminase),LDL(low density lipoprotein cholesterin),TG(triglyceride)
to monitor adverse drug reaction

Full Information

First Posted
March 30, 2011
Last Updated
April 12, 2011
Sponsor
General Hospital of Chinese Armed Police Forces
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1. Study Identification

Unique Protocol Identification Number
NCT01334671
Brief Title
The Clinical Effect of Intensive Statin Therapy in STEMI Patients Before Emergency PCI
Official Title
The Clinical Effect of Intensive Statin Therapy in STEMI(ST-elevated Myocardial Infarction) Patients Before Emergency PCI(Percutaneous Coronary Intervention)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
General Hospital of Chinese Armed Police Forces

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation Myocardial Infarction, (STEMI)
Keywords
ST-elevation myocardial infarction(STEMI), emergency percutaneous coronary intervention(PCI), lipitor or Atorvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1, Atorvastatin
Arm Type
Experimental
Arm Description
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
Arm Title
group 2 , Atorvastatin
Arm Type
Experimental
Arm Description
Group 2 will be administered with atorvastatin 40mg per day for one month,then 20mg per day until the end of the trial
Arm Title
group 3 , Atorvastatin
Arm Type
Experimental
Arm Description
Group 3 will be administered with atorvastatin 20mg per day until the end of the trial
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
lipitol
Intervention Description
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
Primary Outcome Measure Information:
Title
MACEs (Major adverse cardiac events)
Description
MACEs were compared among three groups during follow-up in STEMI patients undergoing emergency PCI.
Time Frame
follow-up for 6 months
Secondary Outcome Measure Information:
Title
Echocardiographic changes
Description
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
Time Frame
postoperative 6 month
Title
HS-CRP,NO,SAA values
Description
to compare hs-crp,no,saa values at differnt treatment period among three groups
Time Frame
preoperation 1 hour,postoperative 24 and 72 hours,postoperative 7 days
Title
CK,CK-MB
Description
to estimate myocardial damage degree among three groups
Time Frame
preoperation 1hour,postoperation 4/8/12/16/20/24hours
Title
AST(glutamic-oxalacetic transaminease ),ALT(glutamic-pyruvic transaminase),LDL(low density lipoprotein cholesterin),TG(triglyceride)
Description
to monitor adverse drug reaction
Time Frame
preoperation 1 hour,postoperation 24 and 72hours,postoperation 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HuiLiang LIU, Doctor
Phone
86-10-57976531
Email
lhl518@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Yang, Doctor
Phone
86-10-57976533
Email
yangyongfmmu@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HuiLiang Liu, Doctor
Organizational Affiliation
Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Chinese People's Armed Police Forces
City
BeiJing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HuiIiang Liu, Doctor
Phone
86-10-57976531
Email
lhl518@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Yong Yang, Doctor
Phone
86-10-57976533
Email
672862837@qq.com;yangyongfmmu@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
HuiLiang Liu, Doctor
First Name & Middle Initial & Last Name & Degree
Yong Yang, Doctors
First Name & Middle Initial & Last Name & Degree
Wenwen Yuan, Master

12. IPD Sharing Statement

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Citation
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Citation
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Citation
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Citation
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Results Reference
derived

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

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