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Completed

NCT Number: NCT01050348

To Investigate the Role of Upstream High Dose Statin in STEMI

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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Key information

Conditions

Acute Myocardial Infarction

Age range

25 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Allegheny General Hospital, Pittsburgh, Pennsylvania, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.
  • Elevated cardiac biomarkers (troponin-T > 0.03ng/ml, CKMB>5ng/mL, or ck>170 U/l).

Exclusion criteria

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

Treatment and study plan

Atorvastatin calcium

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.

Other names: Lipitor

Inactive Placebo

Drug

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

Other names: Placebo, Sugar Pill

Primary outcomes

  1. Major adverse cardiovascular event (MACE) defined as cardiovascular death, MI, or target revascularization 30 days post percutaneous intervention.

    Time frame: 15 and 30 days post revascularization

Secondary outcomes

  1. Any increase in mean peak values of CK-MB, troponin I and myoglobin greater than twice the upper limit after intervention.

    Time frame: 15 and 30 days post revascularization

  2. Any occurrence of major adverse cardiac events defined as death, MI, congestive heart failure, cardiogenic shock or need for unplanned revascularization within 24 hours after procedure or need for emergent CABG.

    Time frame: 15 and 30 days post revascularization

  3. Symptomatic side effects of current statin medication as described by adverse effects on consent form.

    Time frame: Immediately post revascularization to 30 days.

  4. Modified Coronary Revascularization Outcome Questionnaire (CROQ-PTCA)

    Time frame: 15 and 30 days post revascularization

Sponsors and collaborators

Lead sponsor

The Western Pennsylvania Hospital

Other

Collaborators

  • West Penn Allegheny Health System

Registry information

Official study title

A Double Blinded Randomized Placebo Controlled Study: To Investigate the Role of Upstream High Dose Statin Treatment in Patients With ST Segment Elevation Myocardial Infarction

Acronym: IMPRES

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 15, 2010
Registry last updated
Oct 5, 2018

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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