Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation

"Long-term safety study in patients included in 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". - CLARINET LT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000909

Enrollment

Registered

2010-03-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Intervention1: Clopidogrel: dose - 0.2 mg/kg , 6 months Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

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

Exclusion criteria: Patients who have had primary efficacy endpoint ( Shunt thrombosis and early cardiac related procedure of thrombotic nature) during the Clarient study.

Design outcomes

Primary

Measure	Time frame
"The main endpoint will be safety as evaluated by the incidence of adverse events and serious adverse events including bleeding. Assessment of clinical safety will rely on recording of all adverse events whatever the seriousness including bleeding reported by the investigator during the protocol planned visits or unscheduled contacts established with the investigator by the patient?s parents or his/her primary care physician." Timepoint: "Day 01 ( Randomization ) , 3 month , 6 month Telephonic calls at 1st , 2nd , 4th , 5th Month "	—

Measure

Time frame

"The main endpoint will be safety as evaluated by the incidence of adverse events and serious adverse events including bleeding. Assessment of clinical safety will rely on recording of all adverse events whatever the seriousness including bleeding reported by the investigator during the protocol planned visits or unscheduled contacts established with the investigator by the patient?s parents or his/her primary care physician." Timepoint: "Day 01 ( Randomization ) , 3 month , 6 month Telephonic calls at 1st , 2nd , 4th , 5th Month "

—

Secondary

Measure	Time frame
"The secondary endpoint will be the efficacy assessed by the occurrence of shunt thrombosis requiring intervention or any death." Timepoint: "Day 01 ( Randomization ) , 3 month , 6 month Telephonic calls at 1st , 2nd , 4th , 5th Month "	—

Countries

Brazil, France, Germany, Hungary, India, Italy, Malaysia, Mexico, Portugal, Russian Federation, Spain, Taiwan, United Kingdom, United States of America

Contacts

Public ContactDr P V Suresh

Narayana Hrudayalaya Institute of Cardiac Sciences

suresh_pgi@yahoo.com91807835000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026