To Investigate the Role of Upstream High Dose Statin in STEMI

Acute Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01050348
• Other study ID #: 09-004 / WPCI 2009-08
• Status: Completed
• Phase: Phase 4
• Start date: June 2009
• Est. completion date: June 2010

Study information

• Verified date: October 2018
• Source: The Western Pennsylvania Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	The Western Pennsylvania Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
The Western Pennsylvania Hospital	West Penn Allegheny Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular event (MACE) defined as cardiovascular death, MI, or target revascularization 30 days post percutaneous intervention.		15 and 30 days post revascularization
Secondary	Any increase in mean peak values of CK-MB, troponin I and myoglobin greater than twice the upper limit after intervention.		15 and 30 days post revascularization
Secondary	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.		15 and 30 days post revascularization
Secondary	Symptomatic side effects of current statin medication as described by adverse effects on consent form.		Immediately post revascularization to 30 days.
Secondary	Modified Coronary Revascularization Outcome Questionnaire (CROQ-PTCA)		15 and 30 days post revascularization