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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01334671
Enrollment
150
Registered
2011-04-13
Start date
2011-02-28
Completion date
2013-03-31
Last updated
2011-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST-elevation Myocardial Infarction, (STEMI)

Keywords

ST-elevation myocardial infarction(STEMI), emergency percutaneous coronary intervention(PCI), lipitor or Atorvastatin

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.

Interventions

DRUGAtorvastatin

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

Sponsors

General Hospital of Chinese Armed Police Forces
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MACEs (Major adverse cardiac events)follow-up for 6 monthsMACEs were compared among three groups during follow-up in STEMI patients undergoing emergency PCI.

Secondary

MeasureTime frameDescription
Echocardiographic changespostoperative 6 monthto 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 valuespreoperation 1 hour,postoperative 24 and 72 hours,postoperative 7 daysto compare hs-crp,no,saa values at differnt treatment period among three groups
CK,CK-MBpreoperation 1hour,postoperation 4/8/12/16/20/24hoursto estimate myocardial damage degree among three groups
AST(glutamic-oxalacetic transaminease ),ALT(glutamic-pyruvic transaminase),LDL(low density lipoprotein cholesterin),TG(triglyceride)preoperation 1 hour,postoperation 24 and 72hours,postoperation 7 daysto monitor adverse drug reaction

Countries

China

Contacts

Primary ContactHuiLiang LIU, Doctor
lhl518@vip.sina.com86-10-57976531
Backup ContactYong Yang, Doctor
yangyongfmmu@yahoo.com.cn86-10-57976533

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026