Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI

STEMI Clinical Trial

Official title:

Effect of Intensive Statin Treatment on 90-day Prognosis of STEMI Patients Undergoing Emergency Primary PCI Compared With Usual Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01033058
• Other study ID #: CHN2009CV005
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 15, 2009
• Last updated: December 23, 2009
• Start date: December 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2009
• Source: Beijing Chao Yang Hospital
• Contact: Xinchun Yang, Prof.
• Phone: +86 10 85231937
• Email: yangxc[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• STEMI

Intervention

Drug:
• atorvastatin
80mg atorvastatin immediately after enrollment, emergency PCI,atorvastatin 40mg/d and other usual medication after PCI
• atorvastatin
No loading dose of statin after enrollment, emergency PCI, atorvastatin 20mg/d and other usual medication after PCI

Locations

Country	Name	City	State
China	Chaoyang Hospital	Beijing	Chaoyang

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital	Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The combined endpoint of 90-day all cause morality, cardiac death, recurrent MI, recurrent symptomatic myocardiac ischemia, target vessel revascularization		2009 Dec- 2011 Mar	No