Effects of Atorvastatin on Myonecrosis
Condition: Coronary Disease
MeSH terms: Acute Coronary Syndrome; Coronary Disease
Intervention: Placebo Oral Tablet; Atorvastatin 80mg; Screening
Intervention description: placebo pre-PCI for ACS; atorvastatin 80 mg pre-angio/PCI; Patients signed consent to be screened for eligibility for randomization to placebo vs. study drug (atorvastatin)
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized trial of 80 mg atorvastatin vs. placebo pre PCI
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute coronary syndrome; Percutaneous coronary intervention; Peri-procedure myocardial infarction

Summary:

      This study is designed as a prospective, randomized, placebo-controlled, double-blind
      analysis of atorvastatin 80 mg versus placebo administered on average 4 hours prior to
      percutaneous coronary intervention [PCI] (at least 2 hours) in patients presenting with
      unstable angina. Only patients with negative cardiac biomarkers, measured on 2 separate
      occasions a few hours apart will be eligible for inclusion. Furthermore, patients already on
      high-dose statin therapy; patients taking any statin within 24 hours prior to the PCI; and
      patients with contraindications to statins will be excluded from the study. The primary
      endpoint is a quantitative troponin level at 18-24 hours after PCI. At an enrollment of a
      total of 150 patients (75 per group), the study is powered to detect a 30% difference in
      troponin level. Secondary endpoints include elevation of creatine kinase (CK) and CK-MB above
      the upper limit of normal, change in C-reactive protein (CRP) levels from baseline and
      thrombolysis in myocardial infarction (TIMI) myocardial perfusion grade. All patients will be
      started on statin therapy the day after the procedure, as deemed appropriate by their
      treating physicians.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be aged 18 or over.

          -  Patients must provide written informed consent.

          -  Patients are presenting with unstable angina (defined as new onset chest pain,
             accelerating chest pain, chest pain at rest and ST-segment depression on the
             electrocardiogram [EKG])

          -  Patients undergoing successful coronary stent implantation of the (presumed) culprit
             lesion (defined as < 50% residual stenosis).

        Exclusion Criteria:

          -  Any patient who is unable to give written informed consent.

          -  Any condition which, in the investigator's opinion, would interfere with optimal
             participation in the study or produce a significant risk to the patient.

          -  Patients presenting with an ST-elevation myocardial infarction (MI).

          -  Patients with elevated troponin, CK, or CK-MB (above the upper limit of normal).

          -  Patients already on high-dose statin therapy (defined as any statin equivalent to
             atorvastatin ≥ 40 mg).

          -  Patients who took any statin agent within 24 hours of presentation to the cardiac
             catheterization laboratory.

          -  Patients with active hepatic disease or myositis, in whom statin therapy is
             contraindicated.

          -  Patients with hypersensitivity to atorvastatin.

          -  Patients with procedural complications, including unsuccessful percutaneous
             transluminal coronary angioplasty (PTCA)/stenting, major side-branch occlusion,
             flow-limiting dissections at the completion of the procedure, emergent coronary artery
             bypass surgery, peri-procedural thrombus formation with distal embolization, stent
             thrombosis within the first 24 hours, repeat emergent PCI within 24 hours, and death
             within 24 hours.

          -  Cardiogenic shock.