ong Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation
Phase 3
Completed
- Conditions
- Health Condition 1: null- Cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt and the shunt is still in place at one year of age.Health Condition 2: Q257- Other congenital malformations ofpulmonary artery
- Registration Number
- CTRI/2009/091/000909
- Lead Sponsor
- SanofiSynthelabo India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 47
Inclusion Criteria
Patients randomized in the CLARINET study who still are receiving the study drug and with the palliative systemic-to-pulmonary artery shunt still in place at 1 year of age, − for whom the investigator?s decision is to continue the study drug treatment based on his/her judgment of the expected benefit/risk of continuing treatment with study drug.
Exclusion Criteria
Patients who have had primary efficacy endpoint ( Shunt thrombosis and early cardiac related procedure of thrombotic nature) during the Clarient study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main endpoint will be safety as evaluated by the incidence of adverse events and serious <br/ ><br>adverse events including bleeding. <br/ ><br>Assessment of clinical safety will rely on recording of all adverse events whatever the seriousness <br/ ><br>including bleeding reported by the investigator during the protocol planned visits or unscheduled <br/ ><br>contacts established with the investigator by the patient?s parents or his/her primary care <br/ ><br>physician. <br/ ><br>Timepoint: Day 01 ( Randomization ) , 3 month , 6 month <br/ ><br> Telephonic calls at 1st , 2nd , 4th , 5th Month <br/ ><br>
- Secondary Outcome Measures
Name Time Method The secondary endpoint will be the efficacy assessed by the occurrence of shunt thrombosis <br/ ><br>requiring intervention or any death. <br/ ><br>Timepoint: Day 01 ( Randomization ) , 3 month , 6 month <br/ ><br> Telephonic calls at 1st , 2nd , 4th , 5th Month <br/ ><br>