Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI

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Capital Medical University

Status and phase

Unknown
Phase 4

Conditions

STEMI

Treatments

Drug: atorvastatin

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01033058
CHN2009CV005

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

500 participants in 2 patient groups

usual care
Active Comparator group
Treatment:
Drug: atorvastatin
intensive statin treatment
Experimental group
Treatment:
Drug: atorvastatin

Trial contacts and locations

1

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Central trial contact

Xinchun Yang, Prof.

Data sourced from clinicaltrials.gov

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