Text Size

Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Beijing Chao Yang Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT01033058
First received: December 15, 2009
Last updated: December 23, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
STEMI
 Drug: atorvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Statins
U.S. FDA Resources

Further study details as provided by Beijing Chao Yang Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: December 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033058

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

Locations
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
Pfizer
Investigators
Principal Investigator: Xinchun Yang, Prof. Beijing Chaoyang Hospital, China
  More Information

No publications provided

Responsible Party: Prof. Yang Xinchun, Beijing Chaoyang Hospital
ClinicalTrials.gov Identifier: NCT01033058     History of Changes
Other Study ID Numbers: CHN2009CV005
Study First Received: December 15, 2009
Last Updated: December 23, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Chao Yang Hospital:
STEMI
atorvastatin
PCI

Additional relevant MeSH terms:
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013