To Investigate the Role of Upstream High Dose Statin in STEMI

NCT01050348 | Completed Phase 4 DMC

• 1 other identifier: 09-004 / WPCI 2009-08
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

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

  Immediately post revascularization to 30 days.

• Modified Coronary Revascularization Outcome Questionnaire (CROQ-PTCA)

  15 and 30 days post revascularization

Study Arms (2)

Atorvastatin calcium

ACTIVE COMPARATOR

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

Drug: Atorvastatin calcium

Sugar Pill

PLACEBO COMPARATOR

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

Drug: Inactive Placebo

Interventions

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.

Also known as: Lipitor

Atorvastatin calcium

Inactive Placebo DRUG

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

Also known as: Placebo, Sugar Pill

Sugar Pill

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Western Pennsylvania Hospital: lead
• West Penn Allegheny Health System: collaborator

Study Sites (2)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

The Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Interventions

Atorvastatin; Sugars

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Carbohydrates

Study Officials

• Venkatraman Srinivasan, MD

  West Penn Allegheny Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: January 15, 2010
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

US (2)