International randomized double blind clinical study evaluating the efficacy and safety of clopidogrel 0.2mg/kg once daily versus placebo in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig shunt) - CLARINET

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000946-38-BE

Enrollment

490

Registered

2006-09-26

Start date

2007-01-24

Completion date

Unknown

Last updated

2012-04-03

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

Conditions

Neonates or infants (age less than or equal to 92 days at the time of randomization) with systemic to pulmonary arterial shunt for palliation of cyanotic congenital heart disease. 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 CAS Number: 120202-66-6 Current Sponsor code: SR25990C Concentration unit: mg/ml milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Neonate or infant (age less than or equal to 92 days at the time of randomization) with cyanotic congenital heart disease. - Treated by any palliative systemic-to-pulmonary artery shunt (closed shunt or open shunt, Norwood, Sano, stent of ductus arteriosus). - Signed informed consent obtained from patient’s legally acceptable representative (parents or guardians). 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: - Active bleeding or increased risk of bleeding (bleeding disorders [e.g., hemophilia, von Willebrand disease], artero-venous malformations, aneurysms) or previous intracranial (Grades II-IV) or life-threatening hemorrhage. - Allergy to 2 or more classes of drug. - Current treatment with thienopyridine (open label clopidogrel or ticlopidine), dipyridamole or oral anticoagulant. - Adjusted gestational age less than 34 weeks. - Unable to receive study drug orally or enterically. - Concurrent use of another experimental drug/device or participation in another investigational drug or device trial within the last 30 days, except if the study involves an FDA approved drug/device. - Current clinically significant or persistent thrombocytopenia, neutropenia, severe hepatic or renal failure (i.e., more than 2.5 times the upper limit for age of hepatic enzymes or creatinine).

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of 0.2 mg/kg/day of clopidogrel versus placebo 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.;Secondary Objective: To assess the safety of clopidogrel in the study population.;Primary end point(s): The primary efficacy criterion is the first occurrence of any component of the primary composite endpoint of: -Any death or -Shunt thrombosis requiring intervention or -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 of thrombotic nature	—

Measure

Time frame

Main Objective: To evaluate the efficacy of 0.2 mg/kg/day of clopidogrel versus placebo 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.;Secondary Objective: To assess the safety of clopidogrel in the study population.;Primary end point(s): The primary efficacy criterion is the first occurrence of any component of the primary composite endpoint of: -Any death or -Shunt thrombosis requiring intervention or -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 of thrombotic nature

—

Countries

Belgium, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Portugal, Sweden, United Kingdom

Outcome results

None listed

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