A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (LATITUDE-TIMI 60)

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.

Conditions

• Acute Coronary Syndrome

Interventions

DRUG

Losmapimod 7.5 mg twice daily

Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets.

DRUG

Placebo twice daily

Subjects will receive placebo as film-coated, round, plain faced tablets.

DRUG

Standard therapy

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.

Sponsors & Collaborators

• The TIMI Study Group

  collaborator OTHER

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-06-03

Primary Completion

2015-12-14

Completion

2015-12-14

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Belgium
• Bulgaria
• Canada
• Chile
• Czechia
• Denmark
• Estonia
• France
• Germany
• Greece
• Hong Kong
• Hungary
• Israel
• Italy
• Mexico
• Netherlands
• New Zealand
• Norway
• Philippines
• Poland
• Romania
• Russia
• Slovakia
• South Africa
• South Korea
• Spain
• Sweden
• Taiwan
• Thailand
• Ukraine
• United Kingdom

Study Locations