Darapladib versus Placebo Following Acute Coronary Syndrome

• Research type

  Research Study

• Full title

  A Clinical Outcomes Study of Darapladib versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)

• IRAS ID

  36193

• Contact name

  Kausik Ray

• Sponsor organisation

  GlaxoSmithKline Research & Development, Ltd

• Eudract number

  2009-012581-32

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Acute Coronary Syndrome (ACS) represents a range of clinical presentations associated with an increased risk of cardiovascular events such as heart attack, stroke and recurrent hospital admissions for heart disease. Despite the implementation of urgent in-hospital interventions (such as coronary revascularization) and chronic post-discharge treatments (such as antiplatelet agents and statins), recent trials have shown that post-ACS patients remain at high risk of future cardiovascular events. There is a known link between increased levels of an enzyme (a chemical messenger in the body) called ??Lp-PLA2?? and cardiovascular events. Darapladib is an experimental medicine which blocks the Lp-PLA2 enzyme. It is hoped that darapladib will provide therapeutic benefits to patients following an ACS, when given in addition to standard treatment. This study, known as SOLID-TIMI 52, will recruit around 11,500 people from about 40 countries, including the UK. The study will compare the effectiveness of darapladib to placebo in the treatment of post-ACS patients. Adults aged 18 years or older who have recently been hospitalised for ACS (within 30 days) will be invited to participate. The study is double-blind, meaning that neither the participant nor the doctor will know which treatment group has been assigned. Participants will receive study medication (in tablet form) for about 3 years. They will visit the clinic/hospital about 10 times during the whole study. There will be around 4 visits during the first year, and then about 2 visits per year until the end of the study. Participants will also receive telephone calls from the study staff about twice each year. Procedures that participants will undergo include: physical examination, vital signs, electrocardiogram and blood and urine sample collection. The study is sponsored by GSK, working in collaboration with the TIMI Study Group.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  09/H0304/85

• Date of REC Opinion

  28 Jan 2010

• REC opinion

  Further Information Favourable Opinion