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Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI

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ClinicalTrials.gov Identifier: NCT01033058
Recruitment Status : Unknown
Verified November 2009 by Beijing Chao Yang Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 16, 2009
Last Update Posted : December 24, 2009
Information provided by:
Beijing Chao Yang Hospital

Brief Summary:
This is a retrospective, randomized, parallel, open-labeled, controlled study to find out whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin treatment compared with routine treatment.

Condition or disease Intervention/treatment Phase
STEMI Drug: atorvastatin Phase 4

Detailed Description:

ARMYDA-ACS, ARMYDA-RECAPTURE and NAPLES II demonstrated that in patients with ASP and NSTE ACS undergoing early PCI, loading dose of atorvastatin before early PCI led to a reduction of prei-PCI MI, recurrent CV events and mortality. While, theses studies included patients with non-ST-segment elevation ACS, requiring PCI; these results cannot be extrapolated directly to patients with ST-segment elevation MI, and these trials included patients sent to an early and selective PCI, but not those undergoing emergency revascularization;

This study is designed to find out whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin treatment compared with routine treatment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Intensive Statin Treatment on 90-day Prognosis of STEMI Patients Undergoing Emergency Primary PCI Compared With Usual Care
Study Start Date : December 2009
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: usual care Drug: atorvastatin
No loading dose of statin after enrollment, emergency PCI, atorvastatin 20mg/d and other usual medication after PCI
Other Name: Lipitor
Experimental: intensive statin treatment Drug: atorvastatin
80mg atorvastatin immediately after enrollment, emergency PCI,atorvastatin 40mg/d and other usual medication after PCI
Other Name: Lipitor

Primary Outcome Measures :
  1. The combined endpoint of 90-day all cause morality, cardiac death, recurrent MI, recurrent symptomatic myocardiac ischemia, target vessel revascularization [ Time Frame: 2009 Dec- 2011 Mar ]

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 20-75 years old
  • myocardiac ischemia symptom of index event appeared less than 12 hours before enrollment.
  • ECG showed elevated ST segment in 3 or more contiguous leads
  • diagnosed with acute STEMI
  • eligible for primary PCI, and primary PCI is scheduled within 2 hours after enrollment

Exclusion Criteria:

  • allergic or experienced serious adverse reaction to HMG-CoA reductase
  • pregnancy, lactation, or child bearing potential women without any effective contraception
  • accompanied with malignant disease
  • active hepatic disease or hepatic dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033058

Contact: Xinchun Yang, Prof. +86 10 85231937 yangxc@medmail.com.cn

China, Chaoyang
Chaoyang Hospital Not yet recruiting
Beijing, Chaoyang, China, 100020
Contact: Yanying Shen, Dr.    85201000      
Principal Investigator: Xinchun Yang, Prof.         
Sponsors and Collaborators
Beijing Chao Yang Hospital
Principal Investigator: Xinchun Yang, Prof. Beijing Chaoyang Hospital, China

Responsible Party: Prof. Yang Xinchun, Beijing Chaoyang Hospital
ClinicalTrials.gov Identifier: NCT01033058     History of Changes
Other Study ID Numbers: CHN2009CV005
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: December 24, 2009
Last Verified: November 2009

Keywords provided by Beijing Chao Yang Hospital:

Additional relevant MeSH terms:
ST Elevation Myocardial Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors