LTS10916 CLARINET LONG TERM Study - Version Number: 1 (electronic 2.0)

• Research type

  Research Study

• Full title

  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

• IRAS ID

  16919

• Sponsor organisation

  Bristol Myers Squibb International Corporation

• Eudract number

  2008-004999-53

• ISRCTN Number

  N/A

• Research summary

  This CLARINET LONG TERM study is designed to determine the safety of the use of clopidogrel over a longer duration of treatment of up to a total of 18 months (an additional 6 months). Patients with congenital heart disease who have been included in the CLARINET study will be eligible to participate in this study. These patients will be between 12 months and 18 months of age and will have had surgical procedures that increase their risk for developing blood clots.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  09/H0106/28

• Date of REC Opinion

  25 Feb 2009

• REC opinion

  Favourable Opinion