A 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 (PM1116197, LATITUDE STUDY) (Short title: LosmApimod To Inhibit p38 MAP kinase as a TherapeUtic target and moDify outcomes after an acute coronary syndromE (LATITUDE)-TIMI 60)
- Conditions
- heart attackacute coronary syndrome10011082
- Registration Number
- NL-OMON41191
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 870
* Patients 35 years and above.
* Hospitalization for NSTEMI or STEMI (see protocol page 30-31 for details).
* At least one of the predictors of cardiovascular disease (see protocol page 31 for details).
* Unable to be randomized prior to coronary revascularization or fibrinolysis for the qualifying MI.
* Severe heart failure or shock (New York Heart Association [NYHA] class III or IV, or Killip class III or IV).
* Ongoing clinical instability (see protocol page 32 for details).
* History of chronic liver disease or severe renal impairment (see protocol page 32 for details).
* Known active tuberculosis, HIV, active opportunistic or other active life threatening infections.
* Vaccination with a live attenuated vaccine within 6 weeks of randomization.
* Pregnancy, lactation.
* Use of another investigational product (see protocol page 33 for details).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Composite of adjudicated MACE that includes the time to first occurrence of CV<br /><br>death, MI or severe recurrent ischemia requiring urgent coronary artery<br /><br>revascularization.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Principal endpoint only: Time to first occurrence of the composite of CV death<br /><br>or MI.</p><br>