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Trial record 1 of 1 for:    NCT01033058
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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
Sponsor:
Collaborator:
Pfizer
Information provided by:
Beijing Chao Yang Hospital

Tracking Information
First Submitted Date  ICMJE December 15, 2009
First Posted Date  ICMJE December 16, 2009
Last Update Posted Date December 24, 2009
Study Start Date  ICMJE December 2009
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI
Official Title  ICMJE Effect of Intensive Statin Treatment on 90-day Prognosis of STEMI Patients Undergoing Emergency Primary PCI Compared With Usual Care
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE STEMI
Intervention  ICMJE
  • Drug: atorvastatin
    80mg atorvastatin immediately after enrollment, emergency PCI,atorvastatin 40mg/d and other usual medication after PCI
    Other Name: Lipitor
  • Drug: atorvastatin
    No loading dose of statin after enrollment, emergency PCI, atorvastatin 20mg/d and other usual medication after PCI
    Other Name: Lipitor
Study Arms  ICMJE
  • Active Comparator: usual care
    Intervention: Drug: atorvastatin
  • Experimental: intensive statin treatment
    Intervention: Drug: atorvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 15, 2009)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2011
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01033058
Other Study ID Numbers  ICMJE CHN2009CV005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Yang Xinchun, Beijing Chaoyang Hospital
Study Sponsor  ICMJE Beijing Chao Yang Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Xinchun Yang, Prof. Beijing Chaoyang Hospital, China
PRS Account Beijing Chao Yang Hospital
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP