Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI
Effect of Intensive Statin Treatment on 90-day Prognosis of STEMI Patients Undergoing Emergency Primary PCI Compared With Usual Care
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 15, 2009
CompletedFirst Posted
Study publicly available on registry
December 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 24, 2009
November 1, 2009
1.2 years
December 15, 2009
December 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The combined endpoint of 90-day all cause morality, cardiac death, recurrent MI, recurrent symptomatic myocardiac ischemia, target vessel revascularization
2009 Dec- 2011 Mar
Study Arms (2)
usual care
ACTIVE COMPARATORintensive statin treatment
EXPERIMENTALInterventions
80mg atorvastatin immediately after enrollment, emergency PCI,atorvastatin 40mg/d and other usual medication after PCI
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Chao Yang Hospitallead
- Pfizercollaborator
Study Sites (1)
Chaoyang Hospital
Beijing, Chaoyang, 100020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xinchun Yang, Prof.
Beijing Chaoyang Hospital, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 15, 2009
First Posted
December 16, 2009
Study Start
December 1, 2009
Primary Completion
March 1, 2011
Study Completion
June 1, 2011
Last Updated
December 24, 2009
Record last verified: 2009-11