Phase 3 N=13,026 Randomized Quadruple-blind Treatment

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

Acute Coronary Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01000727 ↗

Enrolled (actual)

13,026

Serious AEs

46.0%

Results posted

Aug 2017

Primary outcome: Primary: Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event — 910; 903 Participants — p=0.929

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Darapladib 160 mg (Drug); Placebo (Drug); Standard Therapy (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event	910; 903	0.929
SECONDARY Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal MI or Non-fatal Stroke) During the Time Period for Follow-up of CV Events	838; 824	0.777
SECONDARY Number of Participants With Cardiovascular Death During the Time Period for Follow-up of Cardiovascular Events	268; 243	0.274
SECONDARY Number of Participants With First Occurrence of MI (Fatal/Nonfatal) During the Time Period for Follow-up of Cardiovascular Events	564; 547	0.631
SECONDARY Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of Cardiovascular Events	130; 145	0.354
SECONDARY Number of Participants With CHD Death During the Time Period for Follow-up of Cardiovascular Events	241; 211	0.161
SECONDARY Number of Participants With Urgent Coronary Revascularization for Myocardial Ischemia During the Time Period for Follow-up of Cardiovascular Events	218; 237	0.360
SECONDARY Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During the Time Period for FU of CV Events	1352; 1290	0.202
SECONDARY Number of Participants With First Occurrence of Any Coronary Revascularization Procedures (Excluding Coronary Revascularization Planned Prior to Randomization, But Performed After Randomization) During the Time Period for Follow-up of Cardiovascular Event	967; 926	0.329
SECONDARY Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Nonfatal Stroke During the Time Period for Follow-up of Cardiovascular Events	928; 914	0.797
SECONDARY Number of Participants With First Occurrence of Any Event in the Composite of CHD Death and Non-fatal MI During the Time Period for Follow-up of Cardiovascular Events	725; 701	0.546
SECONDARY Number of Participants With All-cause Mortality During the Time Period for Vital Status	403; 376	0.362

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).

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.
Clinically stable for 24 hours prior to study entry.
A planned percutaneous coronary intervention (PCI) should be performed prior to study entry, whenever possible.
At least one of the following:
At least 60 years old.
Myocardial infarction prior to the qualifying ACS event.
Diabetes mellitus requiring treatment with medication.
Diagnosed mild or moderate reduction in kidney function.
Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral artery disease.

Exclusion Criteria

ACS symptoms or lab results not believed to be caused by a narrowing or blocked coronary artery.
No major coronary artery with a blockage of more than 50% (unless all stenoses are successfully treated by PCI).
Planned coronary artery bypass graft (CABG) surgery, or CABG surgery performed after the qualifying ACS event and prior to study entry.
Certain types of liver disease.
Severe reduction in kidney function OR removal of a kidney OR kidney transplant.
Severe heart failure.
Blood pressure higher than normal despite lifestyle changes and treatment with medications.
Any life-threatening disease with a life expectancy of less than 2 years (other than heart disease) that may prevent the subject from completing the study.
Severe asthma that is poorly controlled with medication.
Pregnancy (Note: A pregnancy test will be performed on all non-sterile women prior to study entry).
Previous severe allergic reaction to food, medications, drink, insect stings, etc.
Drug or alcohol abuse within the past 6 months. Mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study.
Certain medications that may interfere with the study medication (these will be identified by the study doctor).
If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less than or equal to 20.0 nmol/min/mL are excluded.
Previously took darapladib (SB-480848).
Participation in a study of an investigational medication within the past 30 days.
Current participation in a study of an investigational device.
Any other reason the investigator deems the subject should not participate in the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01000727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.