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To Investigate the Role of Upstream High Dose Statin in STEMI (IMPRES)

T

The Western Pennsylvania Hospital

Status and phase

Completed
Phase 4

Conditions

Acute Myocardial Infarction

Treatments

Drug: Inactive Placebo
Drug: Atorvastatin calcium

Study type

Interventional

Funder types

Other

Identifiers

NCT01050348
09-004 / WPCI 2009-08

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

25 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 2 patient groups, including a placebo group

Atorvastatin calcium
Active Comparator group
Description:
Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery
Treatment:
Drug: Atorvastatin calcium
Sugar Pill
Placebo Comparator group
Description:
Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery
Treatment:
Drug: Inactive Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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