Reassessment of Anti-Platelet Therapy Using an Individualized Strategy With Pharmacogenomics to Refine Anti-Platelet Drugs in Vulnerable Patients to Eliminate Thrombotic and Bleeding Complications - A Cluster Randomized Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 1,760
- 试验地点
- 1
研究概览
简要总结
RAPID PREVENT aims to identify if a personalized (targeted) anti-platelet strategy will reduce bleeding events when compared to the current standard anti-platelet therapy.
详细描述
RAPID PREVENT is a Phase IV, single centre, physician initiated, cluster randomized pilot trial evaluating a personalized antiplatelet strategy for patients with acute coronary syndrome (ACS) with High Bleeding Risk (HBR) undergoing percutaneous coronary intervention (PCI). Monthly clusters are randomized 1:1 to either standard of care or personalized therapy guided by HBR algorithm and point of care CYP2C19 genotyping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the study, participants and clinicians cannot be blinded to the study treatment, however outcome adjudicators will remain blinded.
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
- •Age >18 years old
- •Receiving PCI with stenting
排除标准
- •Inability to take ticagrelor
- •Inability to take clopidogrel
- •Not expected to survive >48hours
- •Not able to complete a buccal swab
研究组 & 干预措施
Personlized Therapy with CYP2C19 genotyping
Participants randomized to this arm will completed a point of care genotyping test to determine the presence or absence of the CYP2C19 gene, and the anti-platelet therapy will be determined by if the gene is present or not.
干预措施: Genotyping guided therapy for anti-platelet management (Drug)
Standard of Care Therapy
Participants randomized to standard of care will receive the standard treatment for this condition.