Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI

Phase 4

• Conditions: STEMI
• Interventions: Drug: atorvastatin

• Registration Number: NCT01033058
• Lead Sponsor: Beijing Chao Yang Hospital

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 Timeline

• Status Verified: 2009-11
• Study Start: 2009-12
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Last Update Submitted: 2009-12-23
• Last Update Posted: 2009-12-24
• Primary Completion: 2011-03
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual care	atorvastatin	-
intensive statin treatment	atorvastatin	-

Primary Outcome Measures

Name	Time	Method
The combined endpoint of 90-day all cause morality, cardiac death, recurrent MI, recurrent symptomatic myocardiac ischemia, target vessel revascularization	2009 Dec- 2011 Mar

Trial Locations

Locations (1)

Chaoyang Hospital; 🇨🇳 Beijing, Chaoyang, China