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

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin calcium
Inactive Placebo
Sponsored by
The Western Pennsylvania Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

25 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Allegheny General Hospital
  • The Western Pennsylvania Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Atorvastatin calcium

Sugar Pill

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Any increase in mean peak values of CK-MB, troponin I and myoglobin greater than twice the upper limit after intervention.
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.
Symptomatic side effects of current statin medication as described by adverse effects on consent form.
Modified Coronary Revascularization Outcome Questionnaire (CROQ-PTCA)

Full Information

First Posted
January 14, 2010
Last Updated
October 3, 2018
Sponsor
The Western Pennsylvania Hospital
Collaborators
West Penn Allegheny Health System
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1. Study Identification

Unique Protocol Identification Number
NCT01050348
Brief Title
To Investigate the Role of Upstream High Dose Statin in STEMI
Acronym
IMPRES
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Western Pennsylvania Hospital
Collaborators
West Penn Allegheny Health System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin calcium
Arm Type
Active Comparator
Arm Description
Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery
Intervention Type
Drug
Intervention Name(s)
Atorvastatin calcium
Other Intervention Name(s)
Lipitor
Intervention Description
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
Intervention Name(s)
Inactive Placebo
Other Intervention Name(s)
Placebo, Sugar Pill
Intervention Description
Eligible patients will receive a placebo orally upon admission to hospital prior to percutaneous intervention of the affected artery.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
Symptomatic side effects of current statin medication as described by adverse effects on consent form.
Time Frame
Immediately post revascularization to 30 days.
Title
Modified Coronary Revascularization Outcome Questionnaire (CROQ-PTCA)
Time Frame
15 and 30 days post revascularization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Venkatraman Srinivasan, MD
Organizational Affiliation
West Penn Allegheny Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
The Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States

12. IPD Sharing Statement

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To Investigate the Role of Upstream High Dose Statin in STEMI

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