Placebo Controlled, Double Blind, Randomized Cardiovascular Outcome Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With ASCVD Not Adequately Controlled Despite Maximally Tolerated Lipid Modifying Therapies
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 9,541
- 试验地点
- 589
- 主要终点
- Major Adverse Cardiovascular Effect (MACE)
研究概览
简要总结
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy.
详细描述
This study will be a placebo-controlled, double-blind, randomized, phase 3 study to evaluate the effect of 10mg Obicetrapib in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy to reduce the risk of cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization. The PREVAIL Study
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)
盲法说明
Matching placebo to active
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
- •Males & females ≥ 18 years age.
- •Established ASCVD including:
- •Coronary artery disease
- •Cerebrovascular disease
- •Peripheral Artery disease
- •On maximally tolerated lipid-modifying therapy
- •Fasting LDL-C ≥ 55 mg/dL
- •Fasting triglycerides < 400 mg/dL
- •Estimated glomerular filtration rate ≥ 30 mL/min
排除标准
- •New York Heart Association class III or IV heart failure or left ventricular ejection fraction < 30%
- •Have been hospitalized for Heart Failure within 5 years prior to screening
- •Had non-fatal MI, non-fatal stroke, non-elective coronary revascularization and/or hospitalization for unstable angina or chest pain within past 3 months prior to screening
- •Uncontrolled hypertension
- •Diagnosis of homozygous familial hypercholesterolemia (HoFH)
- •Active liver disease
- •HbA1c ≥10%
- •Thyroid Stimulating Hormone (TSH) > 1.5 times upper limit normal
- •Creatine kinase > 3 times upper limit normal
- •History of malignancy with surgery in past 3 years
- •History of alcohol or drug abuse within past 5 years
- •Received treatment with investigational product or device within past 30 days excluding Coronavirus treatment or vaccine
- •Known allergy to study drug
- •Participated in previous obicetrapib trial
- •Taking gemfibrozil within 30 days screening
研究组 & 干预措施
obicetrapib 10mg
one 10mg tablet, once daily.
干预措施: Obicetrapib (Drug)
Placebo
one placebo tablet, once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Major Adverse Cardiovascular Effect (MACE)
时间窗: 30 months after last participant randomized
To evaluate the effect of obicetrapib on the risk of MACE
次要结局
未报告次要终点