Conditions: Acute Coronary Syndrome
Keywords: Myocardial infarction Acute coronary syndrome Cardiovascular disease p38 mitogen-activated protein kinase (MAPK) inhibitor NSTEMI Losmapimod STEMI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3503
Healthy volunteers: no

Brief summary:
Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing understanding that the inflammatory response to ACS is integral to the subsequent evolution of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an enzyme which may play a central role in inflammation in the setting of heart attack. Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and thus reduce infarct size and the risk of subsequent cardiac events. This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as death, heart attack, or near heart attack requiring urgent treatment ) when started immediately after ACS (specifically, heart attack). Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo, which will be administered in addition to the usual standard of care therapies for heart attack. Following the in-hospital period, subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.

Detailed description:

Arms:
arm 1: Losmapimod 7.5 mg twice daily oral tablet arm 2: Placebo twice daily oral tablet

Interventions: intervention 1: Losmapimod 7.5 mg twice daily intervention 2: Placebo twice daily intervention 3: Standard therapy
Intervention descriptions: intervention 1: Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets. intervention 2: Subjects will receive placebo as film-coated, round, plain faced tablets. intervention 3: Subjects will receive standard therapy consistent with the appropriate guidelines from professional societies. The standard therapy includes nitrates, morphine sulfate, beta adrenergic blockers, renin-angiotensin aldosterone inhibitors, other anti-ischemic therapies, and analgesic therapy.

Protocol document: