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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01033058

Enrollment

500

Registered

2009-12-16

Start date

2009-12-31

Completion date

2011-06-30

Last updated

2009-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

STEMI

Keywords

STEMI, atorvastatin, PCI

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.

Interventions

DRUGatorvastatin

80mg atorvastatin immediately after enrollment, emergency PCI,atorvastatin 40mg/d and other usual medication after PCI

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactXinchun Yang, Prof.

yangxc@medmail.com.cn+86 10 85231937

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026