The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial

(SOLID-TIMI 52 Trial)

Recruiting in Palo Alto (17 mi)

+717 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g. medical procedures performed to restore the normal blood flow in patients with atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome (also called ACS).

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

Signed written informed consent.

Men or women at least 18 years old (in Taiwan, at least 20 years old). Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.

Hospitalization for acute coronary syndrome (ACS) within 30 days prior to study entry.

Treatment Details

Interventions

• Darapladib 160 mg (Other)
• Placebo (Other)
• Standard Therapy (Other)

Participant Groups

Group I: Darapladib 160 mg Experimental Treatment 2 Interventions

Single daily oral tablet

Group II: Placebo Placebo Group 2 Interventions

Single daily oral tablet

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

The TIMI Study Group

Collaborator

Trials

22

Recruited

129,000+