null - FindTrial

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 LONG TERM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004999-53-PT

Enrollment

Registered

2008-10-24

Start date

2009-02-06

Completion date

Unknown

Last updated

2012-07-24

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

Conditions

Patients at one year of age who are included in CLARINET, with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt, and for whom the shunt is still in place. MedDRA version: 8.1 Level: LLT Classification code 10019273 Term: Heart disease congenital

Interventions

Trade Name: Plavix Pharmaceutical Form: Powder and solvent for oral solution INN or Proposed INN: clopidogrel hydrogen sulfate CAS Number: 120202-66-6 Current Sponsor code: SR25990C Concentration unit

Eligibility

Sex/Gender

All

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 and - for whom the parents/guardian have signed the informed consent to participate in this long-term safety study. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients who have had a primary efficacy endpoint (shunt thrombosis or early cardiac related procedure of thrombotic nature) during the CLARINET study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the safety up to 18 months of age of the extended use of 0.2 mg/kg/day clopidogrel in patients who are 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. ;Secondary Objective: To assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.;Primary end point(s): The main endpoint will be safety evaluated by the incidence of adverse events and serious adverse events including bleeding.	—

Measure

Time frame

Main Objective: To determine the safety up to 18 months of age of the extended use of 0.2 mg/kg/day clopidogrel in patients who are 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. ;Secondary Objective: To assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.;Primary end point(s): The main endpoint will be safety evaluated by the incidence of adverse events and serious adverse events including bleeding.

—

Countries

Belgium, France, Germany, Hungary, Italy, Portugal, Spain, United Kingdom

Outcome results

None listed

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