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NCT Number: NCT00808717

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

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.

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Key information

Conditions

Myocardial Infarction Angioplasty Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Percutaneous Coronary Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient must be at least 18 years and 80 years of age.
  • 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.
  • The patient or guardian agrees to the study protocol and provides informed, written consent.

Exclusion criteria

  • Patients to whom PCI can not be undergone within 12 hours from receiving the study drug
  • Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mmHg
  • 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
  • History of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit
  • Severe or malignant hypertension (= sitting SBP > 180 mmHg and/or sitting DBP > 105 mmHg)
  • 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)
  • The patients who might die of other disease than cardiac disease during the trial.

Treatment and study plan

atorvastatin

Drug

Atorvastatin 10 mg vs. 80 mg before intervention

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Efficacy of High Dose Atorvastatin Loading in ST Elevation Myocardial Infarction

Acronym: STATIN STEMI

Important dates

Study start
2007
Primary completion
2008
First posted
Dec 16, 2008
Registry last updated
Jul 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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