International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel 0.2 mg/kg Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 906
- 试验地点
- 3
- 主要终点
- Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)
研究概览
简要总结
Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important.
The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day for the reduction of all cause mortality and shunt related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig Shunt [BTS]).
The secondary objective was to assess the safety of Clopidogrel in the study population.
详细描述
In this event-driven study, participants were to be randomized and treated as soon as possible after shunt placement. They were then to be treated and followed until the primary endpoint criteria was reached i.e. (shunt thrombosis, the next surgical procedure for correction of the congenital heart disease or death) or one year of age or the common study-end-date, which ever came first.
The common study-en-date was defined as the date when it was projected that 172 participants would have reached the primary endpoint criteria.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 92 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cyanotic congenital heart disease treated by any palliative systemic-to-pulmonary artery shunt.
排除标准
- •Active bleeding or increase risk of bleeding,
- •Allergy to 2 or more classes of drug,
- •Unable to receive drug orally or enterically,
- •Current clinically significant or persistent thrombocytopenia, neutropenia, severe hepatic or renal failure.
研究组 & 干预措施
Placebo
干预措施: placebo (Drug)
Clopidogrel 0.2 mg/kg/day
干预措施: Clopidogrel (SR25990) (Drug)
结局指标
主要结局
Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)
时间窗: Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)
The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered to be of thrombotic nature by the blinded adjudication committee. Only the first event was counted.
次要结局
- Number of Participants With Bleeding Events(From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first)
- Number of Participants According to Bleeding Type/Etiology(From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first)