The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial (SOLID-TIMI 52)

This study has been completed.
Sponsor:
Collaborator:
The TIMI Study Group
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01000727
First received: October 22, 2009
Last updated: October 9, 2014
Last verified: October 2014

October 22, 2009
October 9, 2014
December 2009
April 2014   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Time to the first occurrence of any component of the composite of Major Adverse Cardiovascular Events [MACE: CV death (death due to a cardiovascular cause), non-fatal myocardial infarction, non-fatal stroke]. [ Time Frame: Through the end of the study. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01000727 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as 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. ] [ Designated as 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. ] [ Designated as 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. ] [ Designated as safety issue: No ]
  • Any coronary revascularization procedures (excluding PCI planned prior to randomization but performed after randomization). [ Time Frame: Up to 1400 days. ] [ Designated as 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. ] [ Designated as safety issue: No ]
  • The composite of CHD death and non-fatal MI. [ Time Frame: Up to 1400 days. ] [ Designated as safety issue: No ]
  • All cause mortality. [ Time Frame: Up to 1400 days. ] [ Designated as safety issue: No ]
  • The composite measure of major coronary events that include the time to first occurrence of coronary heart disease death, non-fatal myocardial infarction or urgent coronary revascularization for myocardial ischemia. [ Time Frame: Through the end of the study. ] [ Designated as safety issue: No ]
  • The composite measure of total coronary events that include the time to first occurrence of coronary heart disease death, non-fatal myocardial infarction, hospitalization for unstable angina, or any coronary revascularization procedure. [ Time Frame: Through the end of the study. ] [ Designated as safety issue: No ]
  • The time to individual components of MACE [cardiovascular death, myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal)]. [ Time Frame: Through the end of the study. ] [ Designated as safety issue: No ]
  • All cause mortality. [ Time Frame: Through the end of the study. ] [ Designated as safety issue: No ]
  • The time to the first occurrence of any component of the composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke. [ Time Frame: Through the end of the study. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial
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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Drug: Darapladib 160 mg
    Lp-PLA2 inhibitor
    Other Name: SB-480848
  • Drug: Placebo
    Placebo administered
  • Other: Standard Therapy
    Guideline mandated therapy for individual's condition
  • Experimental: Darapladib 160 mg
    Single daily oral tablet
    Interventions:
    • Drug: Darapladib 160 mg
    • Other: Standard Therapy
  • Placebo Comparator: Placebo
    Single daily oral tablet
    Interventions:
    • Drug: Placebo
    • Other: Standard Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13026
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   United States,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Czech Republic,   United Kingdom,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   New Zealand,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine
 
NCT01000727
480848/033
Yes
GlaxoSmithKline
GlaxoSmithKline
The TIMI Study Group
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP