Status:
TERMINATED
Effects of Atorvastatin on Myonecrosis
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Pfizer
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 inter...
Detailed Description
STUDY OBJECTIVES: 1. The primary endpoint of the study is to evaluate the effects of a single high dose of atorvastatin versus placebo on peri-procedural myonecrosis, as measured by troponin T (TnT),...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00344019
Start Date
May 1 2006
End Date
January 1 2009
Last Update
January 2 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215