The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by Near-Infrared Spectroscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Change From Baseline Lipid Pool to Follow up as Assessed by NIRS/IVUS With Treatment of Ticagrelor
研究概览
简要总结
The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by Near-Infrared Spectroscopy study will evaluate whether ticagrelor leads to a 20% reduction in the LCBI with NIRS/IVUS suggesting coronary plaque stabilization and reduced inflammation in patients already on long-term statin therapy undergoing non-urgent PCI. It is hypothesized that the treatment with ticagrelor following PCI will lead to a significant 20% reduction in the lipid pool as measured by NIRS/IVUS at follow-up when compared with baseline imaging, suggesting a reduction in inflammation and stabilization of the lipid core in atherosclerotic lesions not treated during the index procedure.
详细描述
Single-Center, open-label study of the effect of ticagrelor on the reduction in the lipid pool in 30 patients with multi-vessel CAD 2 Treatment periods over 6 months, with 2 additional follow-up phone calls at 1 and 3 months.
Non-urgent PCI requiring stent placement and evaluation by NIRS/IVUS at baseline and 6 month follow up A second concomitant coronary lesion with diameter stenosis greater than 50% will also be imaged using NIRS/IVUS.
Patients will be discharged on a ticagrelor regiment of 90 mg twice a day for the 6 month study.
Blood samples will be drawn at baseline prior to ticagrelor being administered and again at follow up.
Inclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •• Female (post menopausal or surgically sterile) and/or male aged 18 years or older
- •Multi-vessel coronary artery disease CAD
- •Statin therapy for minimum of 6 weeks prior to enrollment in the study with no plan for further adjustment
- •Non-emergent PCI for ACS with stent placement requiring dual-antiplatelet therapy
- •Ability to safely perform NIRS/IVUS for a concomitant non-culprit lesion with diameter stenosis ≥50% that was not treated with PCI
- •Willing and able to sign informed consent and participate in follow-up
排除标准
- •Thienopyridine or ticagrelor use in the last month
- •Need for coronary artery bypass surgery or other surgeries during the follow-up period
- •Documented medication non-compliance
- •Chronic inflammatory disorder or treatment with anti-inflammatory or immunosuppressive drugs
- •Prior or current malignancy within the last 5 years
- •Concomitant severe illness or reduced life expectancy that will prevent follow-up cardiac catheterization
- •Active infection
- •Pregnant or lactating women
- •End-stage renal disease
- •History of intracranial hemorrhage
- •Active pathological bleeding
- •Known severe hepatic impairment
- •Known hypersensitivity to ticagrelor
研究组 & 干预措施
Patiens Discharged on Ticagrelor
Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months.
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Change From Baseline Lipid Pool to Follow up as Assessed by NIRS/IVUS With Treatment of Ticagrelor
时间窗: 6 months
Treatment with ticagrelor following PCI will lead to significant 20% reduction in the LCBI as assessed at follow up by NIRS/IVUS when compared with baseline imaging data of the reference vessel, suggesting a reduction in inflammation and stabilization of the lipid core in atherosclerotic lesions not treated during the index procedure.
次要结局
- Change From Baseline Inflammatory Markers to Follow up With Treatment of Ticagrelor(6 months)