Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI
NCT01033058
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- 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
- 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
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- Beijing, Chaoyang
Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |