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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00799903




Registration number
NCT00799903
Ethics application status
Date submitted
26/11/2008
Date registered
1/12/2008
Date last updated
10/08/2017

Titles & IDs
Public title
The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial
Scientific 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)
Secondary ID [1] 0 0
100601
Universal Trial Number (UTN)
Trial acronym
STABILITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darapladib
Treatment: Drugs - Placebo

Experimental: Darapladib - Single daily oral tablet

Placebo Comparator: Placebo - Single daily oral tablet


Treatment: Drugs: Darapladib
Lp-PLA2 inhibitor administered in addition to standard therapy

Treatment: Drugs: Placebo
Placebo administered in addition to standard therapy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
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 outcome [1] 0 0
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
Timepoint [1] 0 0
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 outcome [2] 0 0
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
Timepoint [2] 0 0
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 outcome [3] 0 0
Number of Participants With CV Death During the Time Period for Follow-up of CV Events
Timepoint [3] 0 0
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 outcome [4] 0 0
Number of Participants With First Occurrence of MI (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events
Timepoint [4] 0 0
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 outcome [5] 0 0
Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events
Timepoint [5] 0 0
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 outcome [6] 0 0
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
Timepoint [6] 0 0
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 outcome [7] 0 0
Number of Participants With All-cause Mortality During the Time Period for Vital Status
Timepoint [7] 0 0
From randomization until death or study completion (up to 4.49 years/average of 3.65 years)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/10/2013
Sample size
Target
Accrual to date
Final
15828
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [3] 0 0
GSK Investigational Site - Concord
Recruitment hospital [4] 0 0
GSK Investigational Site - Gosford
Recruitment hospital [5] 0 0
GSK Investigational Site - Liverpool
Recruitment hospital [6] 0 0
GSK Investigational Site - Auchenflower
Recruitment hospital [7] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [8] 0 0
GSK Investigational Site - Sherwood
Recruitment hospital [9] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [10] 0 0
GSK Investigational Site - Ballarat
Recruitment hospital [11] 0 0
GSK Investigational Site - Caulfield South
Recruitment hospital [12] 0 0
GSK Investigational Site - Frankston
Recruitment hospital [13] 0 0
GSK Investigational Site - Malvern
Recruitment hospital [14] 0 0
GSK Investigational Site - Fremantle
Recruitment hospital [15] 0 0
GSK Investigational Site - Joondalup
Recruitment hospital [16] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2250 - Gosford
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment postcode(s) [6] 0 0
4066 - Auchenflower
Recruitment postcode(s) [7] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [8] 0 0
4075 - Sherwood
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
- Ballarat
Recruitment postcode(s) [11] 0 0
3162 - Caulfield South
Recruitment postcode(s) [12] 0 0
3199 - Frankston
Recruitment postcode(s) [13] 0 0
3144 - Malvern
Recruitment postcode(s) [14] 0 0
6160 - Fremantle
Recruitment postcode(s) [15] 0 0
6027 - Joondalup
Recruitment postcode(s) [16] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Chrudim
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Kladno
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Kolin
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Milevsko
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Pisek
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Pribram
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Slany
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Svitavy
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Tabor
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Esbjerg
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Roubaix
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Bayern
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Sachsen-Anhalt
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Sachsen
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Berlin
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Chiba
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Fukuoka
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00799903
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries