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CompletedNCT00808717STATIN STEMIUpdated Jul 15, 2009

Efficacy of High Dose atorvaSTATIN Loading Before Primary Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction (STATIN STEMI)

A Phase 4 interventional study of Atorvastatin in Myocardial Infarction, Angioplasty and Percutaneous Coronary, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-07-15.

Sponsored by Yonsei University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Although statin prior to PCI has favorable effects in stable angina and ACS except ST elevation MI (STEMI), there have been few studies for STEMI. Celik T et al. reported in patients with STEMI that prior statin use may improve coronary blood flow after PCI in patients with AMI, possibly by its beneficial effects on microvascular function. But this study was retrospective, non-randomized study and evaluated the effects for chronic statin therapy not acute high dose effect. Therefore, the investigators investigated whether acute high-dose statin prior to primary PCI in ST segment elevation myocardial infarction can have beneficial effect or not for periprocedural period and 30 days-cardiac events.

02

Conditions studied

  • Myocardial Infarction
  • Angioplasty
  • Percutaneous Coronary

Keywords

  • Myocardial Infarction
  • Coronary Angioplasty
  • Myocardial infarction, Angioplasty, Transluminal, Percutaneous Coronary
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 170 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The patient must be at least 18 years and 80 years of age.
  2. The patient had the symptoms of acute myocardial infarction within 12 hours with ST segment elevation of more than 1 mm in at least two contiguous leads of EKG or new onset LBBB.
  3. The patient or guardian agrees to the study protocol and provides informed, written consent.

Exclusion criteria

Exclusion Criteria:

  1. Patients to whom PCI can not be undergone within 12 hours from receiving the study drug
  2. Cardiogenic shock or symptomatic hypotension or sitting SBP \< 95 mmHg
  3. The history of major surgery, trauma, retinal hemorrhage, significant gastrointestinal or genitourinary bleeding within recent 6 weeks; history of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit
  4. History of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit
  5. Severe or malignant hypertension (= sitting SBP > 180 mmHg and/or sitting DBP > 105 mmHg)
  6. The history or diagnosis of vasculitis; renal insufficiency (the level of serum creatinine is two times higher than the upper limit of normal of each center)
  7. The patients who might die of other disease than cardiac disease during the trial.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (estimated)

Study arms

  • Experimental
    High dose Atorvastatin 80 mg

    Administered Atorvastatin 80 mg before intervention

    Drug: Atorvastatin

  • Active comparator
    Control

    Administered Atorvastatin 10 mg before intervention

    Drug: Atorvastatin

Interventions

  • DrugAtorvastatin

    Atorvastatin 10 mg vs. 80 mg before intervention

06

What researchers measure

Primary outcomes

  1. To evaluate the effect of high dose atorvastatin in STEMI - 30 Days MACE(death, myocardial infarction, target vessel revascularization)

    Time frame: 30 days

Secondary outcomes

  1. To evaluate the safety of high dose atorvastatin in STEMI - TIMI flow at before and after PCI - Myocardial blush grade after PCI - Procedural success (No reflow incidence) - MACE at 6 month - Periprocedural MI

    Time frame: immediate, 30 days, 6 months

07

Study locations

1 site
  • Severance Hospital
    Seoul, 120-752, Korea, Republic of
08

References and documents

Publications

  • Kim JS, Kim J, Choi D, Lee CJ, Lee SH, Ko YG, Hong MK, Kim BK, Oh SJ, Jeon DW, Yang JY, Cho JR, Lee NH, Cho YH, Cho DK, Jang Y. Efficacy of high-dose atorvastatin loading before primary percutaneous coronary intervention in ST-segment elevation myocardial infarction: the STATIN STEMI trial. JACC Cardiovasc Interv. 2010 Mar;3(3):332-9. doi: 10.1016/j.jcin.2009.11.021. Erratum In: JACC Cardiovasc Interv. 2012 Feb;5(2):248. PubMed 20298994 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00808717
Lead sponsor
Yonsei University
First posted
Dec 16, 2008
Start date
Jul 2007
Primary completion
Dec 2008
Last update
Jul 15, 2009

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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