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

NCT ID: NCT01334671

Last Updated: 2011-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-03-31

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.

Conditions

ST-elevation Myocardial Infarction; (STEMI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

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

group 3 , Atorvastatin

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

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

lipitol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Chinese Armed Police Forces

OTHER

Sponsor Role: lead

Responsible Party

Department of Cardiology of General Hospital of Chinese People's Armed Police Forces

Principal Investigators

HuiLiang Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology of General Hospital of Chinese People's Armed Police Forces

Locations

General Hospital of Chinese People's Armed Police Forces

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

HuiLiang LIU, Doctor

Role: CONTACT

lhl518@vip.sina.com

86-10-57976531

Yong Yang, Doctor

Role: CONTACT

yangyongfmmu@yahoo.com.cn

86-10-57976533

Facility Contacts

HuiIiang Liu, Doctor

Role: primary

lhl518@vip.sina.com

86-10-57976531

Yong Yang, Doctor

Role: backup

672862837@qq.com;yangyongfmmu@yahoo.com.cn

86-10-57976533

References

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Reference Type: RESULT

PMID: 15861319 (View on PubMed)

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. doi: 10.1016/j.ijcard.2005.01.068.

Reference Type: RESULT

PMID: 16337036 (View on PubMed)

Katayama 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

Reference Type: RESULT

Topol 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.

Reference Type: RESULT

PMID: 15007111 (View on PubMed)

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 16916504 (View on PubMed)

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 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.

Reference Type: RESULT

PMID: 16168297 (View on PubMed)

Liu 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.

Reference Type: DERIVED

PMID: 23410871 (View on PubMed)

Other Identifiers

W2-2009041

Identifier Type: -

Identifier Source: org_study_id