A study of Losmapimod (GW856553) to treat heart disease (V1)

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled study to evaluate the safety of 12 weeks of dosing with GW856553 and its effects on inflammatory markers, infarct size, and cardiac function in subjects with myocardial infarction without ST-segment elevation.

• IRAS ID

  22801

• Contact name

  Michael Marber

• Eudract number

  2009-010615-32

• ISRCTN Number

  NA

• Research summary

  Acute Coronary Syndrome (ACS) is a general term that describes a heart attack or unstable angina. A heart attack happens when fatty plaques in the lining of arteries burst, causing a clot to form that can totally or partially block blood flow to the heart. Partial blockage may lead to a type of Ó?minor? heart attack called a NSTEMI (Non-ST - segment elevation myocardial infarction). The risk of another heart attack, heart failure or death is greatest for the next 24 hours and is still high for 6 months. This study aims to show the beneficial effects of GW856553 or Losmapimod (a p38 mitogen activated protein kinase (MAPK) enzyme inhibitor).GW856553 interrupts the process of inflammation. GW856553 could stabilise and prevent fatty plaques from bursting and so prevent a blood clot forming. GW856553 could also help ameliorate the consequences of oxygen deprivation to the heart muscle during ACS, reducing further damage to the heart. Patients diagnosed in hospital with a NSTEMI may receive GW856553 or placebo tablets for 12 weeks. During screening subjects may undergo angiography and percutaneous coronary intervention (PCI), a routine procedure to check and treat the inside of the blood vessels. After hospital discharge patients will return to clinic 5 times, followed by a telephone call after six months. During the study, patients will undergo blood tests, pregnancy tests (for women who might be able to get pregnant), blood pressure and ECG monitoring (heart monitoring). Throughout the trial patients will continue to receive the usual standard of care in addition to this treatment. The total study duration will be 6 months. Patients may also be invited to take part in an MRI / flow sub study which can help measure the size of the heart attack and the flow of blood through the heart.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  09/H0804/65

• Date of REC Opinion

  10 Aug 2009

• REC opinion

  Further Information Favourable Opinion