NCT07625306尚未招募3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating the Efficacy, Safety, Tolerability, and Coronary Plaque Effects of Early Pelacarsen (TQJ230) Initiation in Patients in the US With Elevated Lp(a) and Recent Acute Coronary Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 240
研究概览
简要总结
CTQJ230A1US13 is a randomized, double-blind, placebo-controlled, multicenter phase IIIb study designed to evaluate the efficacy, safety, tolerability, and coronary plaque effects of early pelacarsen (TQJ230) initiation in participants with elevated Lp(a) and recent acute coronary syndrome (ACS).
详细描述
This study consists of Lp(a) measurement and additional screening assessments, a double-blind treatment period of 18 months, and a 16-week safety follow up period from the last dose. Efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo will be assessed throughout the study, with primary analysis at Day 180 and final analysis at Day 540.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lp(a) ≥ 150 nmol/L
- •Within 10 days of hospitalization for ACS event and meets all of the following criteria:
- •Clinical syndrome consistent with spontaneous cardiac ischemia
- •Diagnosis of ACS: ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI)
排除标准
- •Uncontrolled hypertension
- •Heart failure New York Heart Association (NYHA) class IV
- •History of malignancy of any organs
- •History of hemorrhagic stroke or other major bleeding
- •Platelet count ≤ LLN
- •Active liver disease or hepatic dysfunction
- •Significant kidney disease
- •Contraindication for CCTA or severe contrast allergy
- •Pregnant or nursing women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究者
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