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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The Western Pennsylvania Hospital
Sponsor:
Collaborator:
West Penn Allegheny Health System
Information provided by (Responsible Party):
The Western Pennsylvania Hospital
ClinicalTrials.gov Identifier:
NCT01050348
First received: January 14, 2010
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Drug: Atorvastatin calcium
Drug: Inactive Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by The Western Pennsylvania Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Symptomatic side effects of current statin medication as described by adverse effects on consent form. [ Time Frame: Immediately post revascularization to 30 days. ] [ Designated as safety issue: Yes ]
  • Modified Coronary Revascularization Outcome Questionnaire (CROQ-PTCA) [ Time Frame: 15 and 30 days post revascularization ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Placebo, Sugar Pill

  Eligibility

Ages Eligible for Study:   25 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050348

Contacts
Contact: Roy Cho, MD rcho@wpahs.org
Contact: Mykie Bianchi 412-578-4316 mbianchi@wpahs.org

Locations
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: David Lasorda, D.O.    412-359-3131 ext 6559    dlasorda@wpahs.org   
The Western Pennsylvania Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Venkatraman Srinivasan, M.D.    412-578-1045    vsriniva@wpahs.org   
Contact: Roy Cho, MD MHSA    412-578-1045    rcho@wpahs.org   
Sponsors and Collaborators
The Western Pennsylvania Hospital
West Penn Allegheny Health System
Investigators
Principal Investigator: Venkatraman Srinivasan, MD West Penn Allegheny Health System
  More Information

No publications provided

Responsible Party: The Western Pennsylvania Hospital
ClinicalTrials.gov Identifier: NCT01050348     History of Changes
Other Study ID Numbers: 09-004 / WPCI 2009-08
Study First Received: January 14, 2010
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014