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| Sponsor: | Sanofi-Aventis |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00396877 |
Purpose
Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important.
The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day 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 (e.g. modified Blalock Taussig Shunt [BTS]).
The secondary objective was to assess the safety of Clopidogrel in the study population.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Defects, Congenital |
Drug: Clopidogrel (SR25990) Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel 0.2 mg/kg Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt |
The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; 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 to be of thrombotic nature by the blinded adjudication committee.
Only the first event was counted.
Bleeding events spanning from signature of the Informed Consent Form up to the last visit were collected as for any Adverse Event.
The 'on-treatment' period was defined as the period from randomization up until 28 days after treatment discontinuation or final follow-up visit, whichever came first, and participants who experienced bleeding events during that period were counted.
| Enrollment: | 906 |
| Study Start Date: | November 2006 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: placebo
Form: reconstituted solution using matching placebo powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight |
| Experimental: Clopidogrel 0.2 mg/kg/day |
Drug: Clopidogrel (SR25990)
Form: reconstituted solution using Clopidogrel powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight Other Name: Plavix
|
In this event-driven study, participants were to be randomized and treated as soon as possible after shunt placement. They were then to be treated and followed until the primary endpoint criteria was reached i.e. (shunt thrombosis, the next surgical procedure for correction of the congenital heart disease or death) or one year of age or the common study-end-date, which ever came first.
The common study-en-date was defined as the date when it was projected that 172 participants would have reached the primary endpoint criteria.
Eligibility| Ages Eligible for Study: | up to 92 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 31 Study Locations| Study Director: | International Clinical Development Clinical Study Director | Sanofi-Aventis |
More Information
| Responsible Party: | International Clinical Development Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00396877 History of Changes |
| Other Study ID Numbers: | EFC5314, 2006-000946-38 |
| Study First Received: | November 7, 2006 |
| Results First Received: | February 15, 2011 |
| Last Updated: | March 24, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
cyanotic congenital heart disease shunt palliation thrombosis clopidogrel |
|
Congenital Abnormalities Heart Defects, Congenital Heart Diseases Cardiovascular Abnormalities Cardiovascular Diseases Clopidogrel Ticlopidine Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions |
Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents |
