A Randomized Clinical Trial to Evaluate the Effects of High Dose Statin and Niacin Therapy on Excised Plaque Biomarkers in Patients Undergoing Carotid Endarterectomy (CEA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Plaque Instability Protein Composite Score
研究概览
简要总结
This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is diagnosed with carotid stenosis AND is scheduled to undergo carotid endarterectomy
- •Female patients of reproductive potential must abstain from sex or use an acceptable method of birth control through out the study
排除标准
- •Patient must undergo CEA less than 4 weeks after entering study
- •Patient has recent history of acute coronary syndrome
- •Patient has has coronary artery bypass graft surgery within 30 days of study start
- •Patient has thyroid disease that has not been treated for more than 6 weeks
- •Patient has donated blood within 8 weeks of study start
- •Patient has poorly controlled diabetes mellitis
- •Patient has human immunodeficiency virus (HIV) or Hepatitis B or C
- •Patient is taking warfarin or other anticoagulants
- •Patient is taking hormone replacement therapy
研究组 & 干预措施
Statin 80 mg + Niacin extended-release (ER)
Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin.
干预措施: Atorvastatin/niacin extended-release (Drug)
Statin 80 mg + Niacin extended-release (ER)
Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin.
干预措施: Simvastatin (Drug)
Statin 10 mg
Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
干预措施: Atorvastatin (Drug)
Statin 10 mg
Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
干预措施: Simvastatin (Drug)
结局指标
主要结局
Plaque Instability Protein Composite Score
时间窗: At time of carotid endarterectomy (after 4 to 12 weeks of dosing)
Each excised plaque was analyzed using an assay of 20 proteins that reflect plaque composition and inflammation. Each protein was assigned scaled signs, with a lower (negative) sign associated with plaque stability and a higher (positive) sign associated with plaque inflammation/instability. The Composite Score was the average amounts of all the 20 proteins with their associated signs. A higher Composite Score is associated with more plaque instability.
Composite Score of Plaque Inflammation/Stability Gene Expression as Assayed by Ribonucleic Acid (RNA) Taqman Analysis
时间窗: At time of carotid endarterectomy (after 4 to 12 weeks of dosing)
Excised carotid plaques were evaluated for the gene expression of 60 biomarkers associated with inflammation ("Hot" biomarkers) \& 25 biomarkers associated with stability ("Cold" biomarkers). Each biomarker was assayed using a quantitative polymerase chain reaction method and results were reported as a Cycle Threshold, (Ct). A Composite Score was calculated by averaging the Ct for each of the 25 "cold" genes, and subtracting the average Ct for the 60 "hot" genes. A higher composite score was associated with greater inflammation and a lower score was associated with stability (non-inflamed).
Total Cholesterol and Free Cholesterol Measured by Enzymatic Chromogenic Assay
时间窗: At time of carotid endarterectomy (after 4 to 12 weeks of dosing)
Cholesterol ester was to be calculated by the following formula: Cholesterol Ester = Total Cholesterol - Free Cholesterol.
次要结局
未报告次要终点