Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yonsei University
Treatments:
Atorvastatin
Atorvastatin Calcium
Criteria
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:

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.