At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 13,026 enrolled
Drug / intervention
Darapladib 160 mg +2 moredrug
Likely dose
Darapladib 160 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).
In Brief
A Phase 3 clinical trial evaluating Darapladib 160 mg, Placebo, and 1 other intervention for Acute Coronary Syndrome. Completed, enrolled 13,026 participants across 914 sites in 36 countries.
Detailed Summary
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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Coronary Syndrome
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Netherlands, New Zealand, Peru, Philippines, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsThe TIMI Study Group
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartDec 2009
Primary CompletionApr 2014
Study CompletionApr 2014
TodayJul 2026
First PostedOct 23, 2009
Enrollment StartDec 1, 2009
Primary CompletionApr 1, 2014
Study CompletionApr 24, 2014
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.7 years ago
Interventions
Darapladib 160 mgdrug
Lp-PLA2 inhibitor
Placebodrug
Placebo administered
Standard Therapyother
Guideline mandated therapy for individual's condition