Effects of Single-Dose Atorvastatin on Peri-Procedural Myonecrosis During Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes - The NO-MI Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Peri-procedural Myonecrosis
研究概览
简要总结
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.
详细描述
STUDY OBJECTIVES:
- 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), during percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndromes (ACS).
- Secondary endpoints include the measurements of other biomarkers of myocyte injury (CK, CK-MB) and inflammation (CRP).
- Other secondary endpoints include the relative angiographic efficacy of atorvastatin versus placebo on the post PCI growth of tissue level perfusion circumference and the post PCI growth of tissue level perfusion brightness using digital subtraction angiography.
METHODS:
I. Selection and Number of Patients
The study subjects are to be selected from those patients presenting to the BIDMC for cardiac catheterization. Eligible patients will be identified in the cardiac catheterization holding area prior to their procedure. After obtaining informed consent, patients will be randomized to a single dose of atorvastatin or placebo, which will be administered in the holding area about 4 hours prior to the procedure. There will be a total of 150 subjects enrolled in the study. There are a total of 2500 PCIs performed at the BIDMC per year, a third of which are for ACS. We anticipate that 30-40% of patients with ACS will be eligible for study participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
placebo oral tablet
placebo on average of 2-4 hours pre angio/PCI for ACS
干预措施: Placebo Oral Tablet (Drug)
atorvastatin 80 mg
80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS
干预措施: Atorvastatin 80mg (Drug)
atorvastatin 80 mg
80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS
干预措施: Screening (Other)
placebo oral tablet
placebo on average of 2-4 hours pre angio/PCI for ACS
干预措施: Screening (Other)
结局指标
主要结局
Peri-procedural Myonecrosis
时间窗: 24 hours
As measured by troponin T (TnT), during percutaneous coronary intervention (PCI). TnT will be measured at 18-24 hours. Assuming a 40% event rate (elevation in TnT), this study powered to predict 30% relative reduction in TnT
次要结局
- Other Biomarkers of Myocyte Injury (CK, CK-MB)(24 hours)
- Post PCI Growth of Tissue Level Perfusion Circumference and Brightness Using Digital Subtraction Angiography(24 hours)
- Inflammatory Markers (CRP)(24 hours)