Long Term Safety Study in Patients Included in the CLARINET Study With Cyanotic Congenital Heart Disease Palliated With a Systemic-to-pulmonary Artery Shunt and for Whom the Shunt is Still in Place at One Year of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Number of Participants With Bleeding Events
研究概览
简要总结
This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt.
The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of age.
The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.
详细描述
Patients remained in the treatment group to which they were originally allocated for the CLARINET study and continued blindly their treatment (0.2 mg/kg/day of clopidogrel or placebo) up to the occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first. The maximum treatment duration were 6 months.
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
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients randomized in the CLARINET study,
- •Still receiving the study drug,
- •Palliative systemic-to-pulmonary artery shunt still in place at 1 year of age,
- •Investigator's decision to continue based on his/her judgment of the expected benefit / risk of continuing treatment with study drug,
- •Signed informed consent to participate in the long-term safety study.
排除标准
- 未提供
研究组 & 干预措施
Placebo
0.2 mL/kg/day matching placebo solution once daily.
干预措施: placebo (Drug)
Clopidogrel 0.2 mg/kg/day
0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Number of Participants With Bleeding Events
时间窗: Up to a maximum of 6 months
All bleeding events experienced during the study period were collected as for any Adverse Event. The 'on-treatment' period was defined as the period from inclusion in the extension study up to 28 days after treatment discontinuation, and participants who experienced bleeding events during that period were counted.
Number of Participants According to Bleeding Type/Etiology
时间窗: Up to a maximum of 6 months
For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology.
次要结局
- Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths(Up to a maximum of 6 months)