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

Last updated: July 14, 2009
Sponsor: Yonsei University
Overall Status: Completed

Phase

4

Condition

Cardiac Ischemia

Heart Disease

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT00808717
4-2007-0156
  • Ages 18-80
  • All Genders

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.

Eligibility Criteria

Inclusion

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 STsegment elevation of more than 1 mm in at least two contiguous leads of EKG or newonset LBBB.

  3. The patient or guardian agrees to the study protocol and provides informed, writtenconsent.

Exclusion

Exclusion Criteria:

  1. Patients to whom PCI can not be undergone within 12 hours from receiving the studydrug

  2. Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mmHg

  3. The history of major surgery, trauma, retinal hemorrhage, significant gastrointestinalor genitourinary bleeding within recent 6 weeks; history of cerebrovascular attackwithin two years, or cerebrovascular attack with a significant residual neurologicaldeficit

  4. History of cerebrovascular attack within two years, or cerebrovascular attack with asignificant residual neurological deficit

  5. Severe or malignant hypertension (= sitting SBP > 180 mmHg and/or sitting DBP > 105mmHg)

  6. The history or diagnosis of vasculitis; renal insufficiency (the level of serumcreatinine 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.

Study Design

Total Participants: 170
Study Start date:
July 01, 2007
Estimated Completion Date:

Connect with a study center

  • Severance Hospital

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

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