Back to resultsIntensive Statin Treatment for STEMI Patients Undergoing Primary PCI
Primary Purpose
STEMI
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
atorvastatin
atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for STEMI focused on measuring STEMI, atorvastatin, PCI
Eligibility 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
Sites / Locations
- Chaoyang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
usual care
intensive statin treatment
Arm Description
Outcomes
Primary Outcome Measures
The combined endpoint of 90-day all cause morality, cardiac death, recurrent MI, recurrent symptomatic myocardiac ischemia, target vessel revascularization
Secondary Outcome Measures
Full Information
NCT ID
NCT01033058
First Posted
December 15, 2009
Last Updated
December 23, 2009
Sponsor
Beijing Chao Yang Hospital
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01033058
Brief Title
Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI
Official Title
Effect of Intensive Statin Treatment on 90-day Prognosis of STEMI Patients Undergoing Emergency Primary PCI Compared With Usual Care
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Beijing Chao Yang Hospital
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI
Keywords
STEMI, atorvastatin, PCI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
usual care
Arm Type
Active Comparator
Arm Title
intensive statin treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
80mg atorvastatin immediately after enrollment, emergency PCI,atorvastatin 40mg/d and other usual medication after PCI
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
No loading dose of statin after enrollment, emergency PCI, atorvastatin 20mg/d and other usual medication after PCI
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinchun Yang, Prof.
Phone
+86 10 85231937
Email
yangxc@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinchun Yang, Prof.
Organizational Affiliation
Beijing Chaoyang Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaoyang Hospital
City
Beijing
State/Province
Chaoyang
ZIP/Postal Code
100020
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanying Shen, Dr.
Phone
85201000
First Name & Middle Initial & Last Name & Degree
Xinchun Yang, Prof.
12. IPD Sharing Statement
Learn more about this trial
Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI
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