Estudio de seguridad a largo plazo en los pacientes incluidos en el estudio CLARINET con cardiopatía congénita cianosante paliada con derivación sistémica a la arteria pulmonar en los cuales persista la derivación al año de edad -------------------------------------------------------- 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

• Register: EUCTR
• Last refreshed on: 19 April 2022
• Main ID: EUCTR2008-004999-53-ES
• Date of registration: 18/12/2008
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis recherche & développement
• Public title: Estudio de seguridad a largo plazo en los pacientes incluidos en el estudio CLARINET con cardiopatía congénita cianosante paliada con derivación sistémica a la arteria pulmonar en los cuales persista la derivación al año de edad -------------------------------------------------------- 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
• Scientific title: Estudio de seguridad a largo plazo en los pacientes incluidos en el estudio CLARINET con cardiopatía congénita cianosante paliada con derivación sistémica a la arteria pulmonar en los cuales persista la derivación al año de edad -------------------------------------------------------- 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
• Date of first enrolment: 18/02/2009
• Target sample size: 32
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004999-53
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

pacientes incluidos en el estudio CLARINET con cardiopatía congénita cianosante paliada con derivación sistémica a la arteria pulmonar en los cuales persista la derivación al año de edad ------------------------------------------------------ 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

Intervention(s)

Trade Name: PLAVIX 75 mg comprimidos con cubierta pelicular
Pharmaceutical Form: Powder and solvent for oral solution
INN or Proposed INN: CLOPIDOGREL
Other descriptive name: CLOPIDOGREL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Powder and solvent for oral solution
Route of administration of the placebo: Oral use

Primary Outcome(s)

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.

Primary end point(s): The main endpoint will be safety evaluated by the incidence of adverse events and serious adverse events including bleeding.

Secondary Objective: To assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.

Secondary ID(s)

2008-004999-53-PT

LTS10916

Ethics review

Status: Approved
Approval date: 06/02/2009
Contact:

Results

• Results available: Yes
• Date Posted: 20/12/2014
• Date Completed: 21/07/2010
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2008-004999-53/results