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

October 3, 2018 updated by: The Western Pennsylvania Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15224
        • The Western Pennsylvania Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Atorvastatin calcium
Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery
Drug: 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.
Other Names:
  • Lipitor
Placebo Comparator: Sugar Pill
Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery
Drug: Inactive Placebo
Eligible patients will receive a placebo orally upon admission to hospital prior to percutaneous intervention of the affected artery.
Other Names:
  • Placebo, Sugar Pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
15 and 30 days post revascularization

Secondary Outcome Measures

Outcome Measure
Time Frame
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
15 and 30 days post revascularization
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
15 and 30 days post revascularization
Symptomatic side effects of current statin medication as described by adverse effects on consent form.
Time Frame: Immediately post revascularization to 30 days.
Immediately post revascularization to 30 days.
Modified Coronary Revascularization Outcome Questionnaire (CROQ-PTCA)
Time Frame: 15 and 30 days post revascularization
15 and 30 days post revascularization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Western Pennsylvania Hospital

Collaborators

West Penn Allegheny Health System

Investigators

  • Principal Investigator: Venkatraman Srinivasan, MD, West Penn Allegheny Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 14, 2010

First Posted (Estimate)

January 15, 2010

Study Record Updates

Last Update Posted (Actual)

October 5, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-004 / WPCI 2009-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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