To Investigate the Role of Upstream High Dose Statin in STEMI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-06-30

Brief Summary

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This is a double-blinded randomized placebo controlled trial investigating the role of upstream 80mg Atorvastastin-calcium in patients undergoing percutaneous intervention for acute STEMI.

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Detailed Description

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Atorvastatin calcium

Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery

Group Type ACTIVE_COMPARATOR

Atorvastatin calcium

Intervention Type DRUG

Eligible patients will receive 80mgs of atorvastatin orally upon admission to hospital prior to percutaneous intervention of the affected artery. Dose of post-procedural statin will be at the discretion of the cardiologist.

Sugar Pill

Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery

Group Type PLACEBO_COMPARATOR

Inactive Placebo

Intervention Type DRUG

Eligible patients will receive a placebo orally upon admission to hospital prior to percutaneous intervention of the affected artery.

Interventions

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Atorvastatin calcium

Eligible patients will receive 80mgs of atorvastatin orally upon admission to hospital prior to percutaneous intervention of the affected artery. Dose of post-procedural statin will be at the discretion of the cardiologist.

Intervention Type DRUG

Inactive Placebo

Eligible patients will receive a placebo orally upon admission to hospital prior to percutaneous intervention of the affected artery.

Intervention Type DRUG

Other Intervention Names

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Lipitor Placebo, Sugar Pill

Eligibility Criteria

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Inclusion Criteria

1. Any patient of 25 to 90 years of age admitted or transferred to Western Pennsylvania Hospital or Allegheny General Hospital with a diagnosis of STEMI undergoing emergent percutaneous intervention (PCI) to the culprit coronary artery. STEMI is defined as greater than 1mm ST segment elevation on electrocardiogram.
2. Elevated cardiac biomarkers (troponin-T \> 0.03ng/ml, CKMB\>5ng/mL, or ck\>170 U/l).

Exclusion Criteria

1. Known history of liver disease defined as cirrhosis, alcoholic liver disease, Non alcoholic steatohepatitis, hepatitis or any causes of liver failure.
2. Renal failure with creatinine \>3mg/dL
3. Known history of liver or muscle disease such as rheumatologic myopathies, history of myositis, hepatitis, and hepatic cancer.
4. Cardiovascular arrest and shock.

Minimum Eligible Age

25 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No