Last updated: 07/17/2024 15:06:25

The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy TrialSTABILITY

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GSK study ID
100601
See study documents
Clinicaltrials.gov ID
NCT00799903
See results summary
EudraCT ID
2008-005575-96
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)
Trial description: This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of participants with first occurrence of any component of the composite of major adverse cardiovascular events (cardiovascular [CV] death, non-fatal myocardial infarction [MI] or non-fatal stroke) during the time period for follow-up of CV events

Timeframe: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

Secondary outcomes:

Number of participants with first occurrence of any event in the composite of major coronary events (coronary heart disease [CHD] death, non-fatal MI, or urgent coronary revascularization [CR] for MI) during the time period for follow-up (FU) of CV events

Timeframe: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

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 time period for FU of CV events

Timeframe: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

Number of participants with CV death during the time period for follow-up of CV events

Timeframe: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

Number of participants with first occurrence of MI (fatal/non-fatal) during the time period for follow-up of CV events

Timeframe: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

Number of participants with first occurrence of stroke (fatal/non-fatal) during the time period for follow-up of CV events

Timeframe: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

Number of participants with first occurrence of any component of the composite of all-cause mortality, non-fatal MI, or non-fatal stroke during the time period for follow-up of CV events

Timeframe: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

Number of participants with all-cause mortality during the time period for vital status

Timeframe: From randomization until death or study completion (up to 4.49 years/average of 3.65 years)

Interventions:
  • Drug: Darapladib
  • Drug: Placebo
    • Enrollment:
    15828
    Primary completion date:
    2013-17-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    The STABILITY Investigators.Effect of Darapladib on Prevention of Ischemic Events in Stable Coronary Heart Disease.N Engl J Med.2014;370(18):1702-1711
    Matthias Wuttke et al (200+ authors).A catalogue of molecular targets for kidney function from genetic 1 analyses of a million individuals.Nat Genet.2019;51:957–972 DOI: 10.1038/s41588-019-0407-x
    Medical condition
    Atherosclerosis
    Product
    darapladib
    Collaborators
    Not applicable
    Study date(s)
    December 2008 to October 2013
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Men or women at least 18 years old. Women must be post-menopausal or using a highly
    • effective method for avoidance of pregnancy.
    • Planned coronary revascularization (such as stent placement or heart bypass) or any other major
    • surgical procedure.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Men or women at least 18 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
    • Current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject.
    • Chronic coronary heart disease
    • At least one of the following:
    • At least 60 years old
    • Diabetes requiring treatment with medication
    • Low HDL cholesterol ("good cholesterol")
    • Currently smoke cigarettes or stopped smoking within the past 3 months
    • 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 arterial disease.
    Exclusion criteria:
    • Planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure.
    • 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 expected to result in death within the next 2 years (other than heart disease)
    • Severe asthma that is poorly controlled with medication
    • Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to study entry)
    • Previous severe allergic response to food, drink, insect stings, etc.
    • Drug or alcohol abuse within the past 6 months OR 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)
    • Participation in a study of an investigational medication within the past 30 days
    • Current participation in a study of an investigational device

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    AMSTERDAM, Netherlands, 1105 AZ
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Aalst, Belgium, 9300
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Aarhus, Denmark, DK-8000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Adrogue, Buenos Aires, Argentina, B1846DSK
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Agia Varvara, Athens, Greece, 123 51
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ahmedabad, India, 380060
    Status
    Study Complete
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2013-17-10
    Actual study completion date
    2013-17-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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