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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004999-53 | EudraCT Number |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt.
The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of age.
The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.
Patients remained in the treatment group to which they were originally allocated for the CLARINET study and continued blindly their treatment (0.2 mg/kg/day of clopidogrel or placebo) up to the occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first. The maximum treatment duration were 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 0.2 mL/kg/day matching placebo solution once daily. |
|
| Clopidogrel 0.2 mg/kg/day | Experimental | 0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | Form: reconstituted solution using Clopidogrel powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Bleeding Events | All bleeding events experienced during the study period were collected as for any Adverse Event. The 'on-treatment' period was defined as the period from inclusion in the extension study up to 28 days after treatment discontinuation, and participants who experienced bleeding events during that period were counted. | Up to a maximum of 6 months |
| Number of Participants According to Bleeding Type/Etiology | For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology. | Up to a maximum of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths | Outcome events, shunt thrombosis requiring intervention or death, experienced during the study period were recorded. Participants were counted excluding the events that occured after the participant's protocol study end (occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first). |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22269735 | Derived | Avlonitis VS, Planas S, Hayes AM, Parry A. Occlusion of modified Blalock-Taussig shunt after clopidogrel cessation. Ann Thorac Surg. 2012 Feb;93(2):656-8. doi: 10.1016/j.athoracsur.2011.07.071. |
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49 participants were enrolled between January 2009 and January 2010 in 25 sites in 15 countries (7 countries involved in CLARINET study were not selected as the delay in obtaining IRB/IEC and Health Authorities approvals would prevent recruitment and/or no patient would be recruited as the second surgery is always performed before 1 year of age).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 0.2 mL/kg/day matching placebo solution once daily |
| FG001 | Clopidogrel 0.2 mg/kg/Day | 0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| placebo | Drug | Form: reconstituted solution using matching placebo powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight |
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| Up to a maximum of 6 months |
| São Paulo |
| Brazil |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-Aventis Administrative Office | Berlin | Germany |
| Sanofi-Aventis Administrative Office | Budapest | Hungary |
| Sanofi-Aventis Administrative Office | Mumbai | India |
| Sanofi-Aventis Administrative Office | Milan | Italy |
| Sanofi-Aventis Administrative Office | Kuala Lumpur | Malaysia |
| Sanofi-Aventis Administrative Office | México | Mexico |
| Sanofi-Aventis Administrative Office | Warsaw | Poland |
| Sanofi-Aventis Administrative Office | Porto Salvo | Portugal |
| Sanofi-Aventis Administrative Office | Moscow | Russia |
| Sanofi-Aventis Administrative Office | Barcelona | Spain |
| Sanofi-Aventis Administrative Office | Taipei | Taiwan |
| Sanofi-Aventis Administrative Office | Guildford Surrey | United Kingdom |
| Treated |
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| Completed Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 0.2 mL/kg/day matching placebo solution once daily |
| BG001 | Clopidogrel 0.2 mg/kg/Day | 0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | days |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight at inclusion | Mean | Standard Deviation | kilograms (kg) |
| ||||||||||||||||
| Height at inclusion | Mean | Standard Deviation | centimeters (cm) |
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| Type of initial shunt palliation | Number | participants |
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| Shunt on cardiopulmonary bypass | Number | participants |
| |||||||||||||||||
| Age at shunt palliation | Mean | Standard Deviation | days |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Bleeding Events | All bleeding events experienced during the study period were collected as for any Adverse Event. The 'on-treatment' period was defined as the period from inclusion in the extension study up to 28 days after treatment discontinuation, and participants who experienced bleeding events during that period were counted. | The analysis was performed on the Intent-to-treat (ITT) population that consisted of all included participants. Participants were analyzed in the treatment arm allocated at randomization into the CLARINET study. | Posted | Number | participants | Up to a maximum of 6 months |
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| Secondary | Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths | Outcome events, shunt thrombosis requiring intervention or death, experienced during the study period were recorded. Participants were counted excluding the events that occured after the participant's protocol study end (occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first). | The analysis was performed on the Intent-to-treat (ITT) population that consisted of all included participants. Participants were analyzed in the treatment arm allocated at randomization into the CLARINET study. | Posted | Number | participants | Up to a maximum of 6 months |
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| Primary | Number of Participants According to Bleeding Type/Etiology | For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology. | The analysis was performed on the same population as previously (i.e. ITT population). | Posted | Number | participants | Up to a maximum of 6 months |
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Up to a maximum of 6 months. All Adverse Events (AE) experienced during the study period were collected regardless of seriousness or relationship to the drug .
The analysis was performed on the intent-to-treat population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from inclusion in the extension study up to 28 days after treatment discontinuation).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 0.2 mL/kg/day matching placebo solution once daily | 3 | 23 | 7 | 23 | ||
| EG001 | Clopidogrel 0.2 mg/kg/Day | 0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily | 6 | 26 | 17 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Low cardiac output syndrome | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Nodal arrhythmia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Pulmonary artery stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any infections and infestations | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Any gastrointestinal disorders | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Any general disorders and administration site conditions | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Any respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Any injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
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| Any skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Any cardiac disorders | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
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If no publication has occurred within 12 months after trial completion, the Investigator can publish the results. Prior to publication, the sponsor shall review the manuscript and can request changes, provided they do not jeopardize the accuracy and/or the scientific value of the publication. The approval is given in writing by the sponsor, not exceeding 90 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | sanofi-aventis | Contact_US@sanofi-aventis.com |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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| Portugal |
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| Taiwan |
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| Spain |
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| Russian Federation |
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| United Kingdom |
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| Italy |
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| India |
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| France |
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| Hungary |
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| Mexico |
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| Brazil |
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| Malaysia |
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| Poland |
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| Germany |
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| Modified Blalock Taussig Shunt without Norwood |
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| Sano procedure with Norwood |
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| Sano procedure without Norwood |
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| Central shunt |
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| Stent of ductus arteriosus |
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| No |
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| - Serious with an outcome of death |
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| - Leading to permanent treatment discontinuation |
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