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

Brief Summary

Official Title: “A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).”

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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: April 2014

Detailed Clinical Trial Description

Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. Following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, 6 months and every 6 months until the end of the study.

Interventions Used in this Clinical Trial

  • Drug: Darapladib 160 mg
    • Lp-PLA2 inhibitor administered in addition to standard therapy.
  • Drug: Placebo
    • Placebo administered in addition to standard therapy.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Darapladib 160 mg
    • Single daily oral tablet
  • Placebo Comparator: Placebo
    • Single daily oral tablet

Outcome Measures for this Clinical Trial

Primary Measures

  • Time to the first occurrence of any component of the composite of major coronary events (i.e., Coronary Heart Disease (CHD) death, non-fatal myocardial infarction (MI), or urgent coronary revascularization for myocardial ischemia).
    • Time Frame: Up to 5 years.
      Safety Issue?: No

Secondary Measures

  • The composite measure of Major Adverse Cardiovascular Event (MACE) that includes cardiovascular (CV) death (death due to a cardiovascular cause), non-fatal MI, or non-fatal stroke.
    • Time Frame: Up to 1400 days.
      Safety Issue?: No
  • Individual components of MACE (CV death, MI (fatal and non-fatal), stroke (fatal and non-fatal)).
    • Time Frame: Up to 1400 days.
      Safety Issue?: No
  • Individual components of major coronary events (CHD death, MI (fatal and non-fatal), urgent coronary revascularization for myocardial ischemia).
    • Time Frame: Up to 1400 days.
      Safety Issue?: No
  • Composite measure of total coronary events that incl. first occurrence of CHD death, non-fatal MI, hosp. for unstable angina(UA), or any coronary revasc. proc.(excl. percutaneous coronary intervention(PCI) planned prior to but performed after rand.).
    • Time Frame: Up to 1400 days.
      Safety Issue?: No
  • Any coronary revascularization procedures (excluding PCI planned prior to randomization but performed after randomization).
    • Time Frame: Up to 1400 days.
      Safety Issue?: No
  • The first occurrence of any component of the composite of all-cause mortality, non-fatal MI, or non-fatal stroke.
    • Time Frame: Up to 1400 days.
      Safety Issue?: No
  • The composite of CHD death and non-fatal MI.
    • Time Frame: Up to 1400 days.
      Safety Issue?: No
  • All cause mortality.
    • Time Frame: Up to 1400 days.
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • GlaxoSmithKline
  • Collaborator
    • The TIMI Study Group
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01000727