Targeting Vascular INflammation in Patients With Community-Acquired Pneumonia (TIN_CAP): a Multi-centre, Prospective, Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- The change over 6 months in the FDG uptake TBR as a marker of arterial plaque inflammation between the icosapent ethyl and placebo groups
研究概览
简要总结
The goal of this clinical trial is to learn if icosapent ethyl (Vascepa) works to lessen the amount of inflammation in adults diagnosed with Community-Acquired Pneumonia (CAP). The main question it aims to answer is:
What is the effect of taking Vascepa on inflammation in the arteries in patients with CAP? Researchers will compare the drug Vascepa to a placebo (a look-alike submstance that contains no drug) to see if Vascepa works to reduce inflammation in patients with CAP.
Participants wil:
- take Vacscepa or a placebo twice a day for 6 months
- Visit the clinic 3 times (baseline, 30 days, and 6 months) for checkups and tests
详细描述
TIN CAP is a multi centre, prospective, randomized, double-blind, placebo-controlled clinical trial to evaluate the use of icosapent ethyl (Vascepa) on vascular inflammation in patients with CAP using FDG-PET/CT imaging and measurement of circulating biomarkers. The current proposal uses a randomized design to:
- measure the effect of icosapent ethyl vs. placebo on reducing arterial inflammation over a 6-month treatment period, with primary analysis at 6-months;
- the correlation between imaging and blood biomarkers over time relative to the drug response.
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
- 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 who have:
- •Hospitalization with CAP (defined as pulmonary infiltration using chest imaging, in addition to other clinical symptoms including fever, cough, and sputum)
- •age > 18 years;
- •given informed consent.
排除标准
- •Patients who have:
- •history of cancer within the last 3 years (other than a successfully treated cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix).
- •active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));
- •pregnancy (all women of child bearing potential will have a negative BHCG test;
- •breastfeeding;
- •Women of childbearing potential who refuse to use two forms of contraception (this includes at least one form of highly effective and one effective method of contraception) throughout the study OR men capable of fathering a child who refuse to use contraception.
- •Allergies to icosapent ethyl
- •allergies to fish or shellfish
- •glomerular filtration rate (GFR) <50 ml/min/1.72m2 (excluded from CTA portion)
- •unable to give informed consent;
- •Exclusion for CTA portion of the protocol:
- •Patients with dye allergy will not undergo CTA but will have PET/CT
研究组 & 干预措施
Treatment
Participants randomized to this arm will receive Vascepa for 6 months.
干预措施: Icosapent Ethyl 1000 MG Oral Capsule [Vascepa] (Drug)
Placebo
Participants randomized to this arm will receive placebo for 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
The change over 6 months in the FDG uptake TBR as a marker of arterial plaque inflammation between the icosapent ethyl and placebo groups
时间窗: 6 months
次要结局
- The change in inflammation, measured on FDG PET, in the pulmonary tissue.(6 months)