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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01000727




Registration number
NCT01000727
Ethics application status
Date submitted
22/10/2009
Date registered
23/10/2009
Date last updated
10/08/2017

Titles & IDs
Public title
The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial
Scientific 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).
Secondary ID [1] 0 0
480848/033
Universal Trial Number (UTN)
Trial acronym
SOLID-TIMI 52
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darapladib 160 mg
Treatment: Drugs - Placebo
Other interventions - Standard Therapy

Experimental: Darapladib 160 mg - Single daily oral tablet

Placebo comparator: Placebo - Single daily oral tablet


Treatment: Drugs: Darapladib 160 mg
Lp-PLA2 inhibitor

Treatment: Drugs: Placebo
Placebo administered

Other interventions: Standard Therapy
Guideline mandated therapy for individual's condition
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
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 3.80 years)
Secondary 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 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 3.80 years)
Secondary outcome [2] 0 0
Number of Participants With Cardiovascular Death During the Time Period for Follow-up of Cardiovascular 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 3.80 years)
Secondary outcome [3] 0 0
Number of Participants With First Occurrence of MI (Fatal/Nonfatal) During the Time Period for Follow-up of Cardiovascular 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 3.80 years)
Secondary outcome [4] 0 0
Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of Cardiovascular 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 3.80 years)
Secondary outcome [5] 0 0
Number of Participants With CHD Death During the Time Period for Follow-up of Cardiovascular 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 3.80 years)
Secondary outcome [6] 0 0
Number of Participants With Urgent Coronary Revascularization for Myocardial Ischemia During the Time Period for Follow-up of Cardiovascular 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 3.80 years)
Secondary outcome [7] 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 the Time Period for FU of CV Events
Timepoint [7] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [11] 0 0
Number of Participants With All-cause Mortality During the Time Period for Vital Status
Timepoint [11] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)

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

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
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/04/2014
Sample size
Target
Accrual to date
Final
13026
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [3] 0 0
GSK Investigational Site - Gosford
Recruitment hospital [4] 0 0
GSK Investigational Site - Auchenflower
Recruitment hospital [5] 0 0
GSK Investigational Site - Herston
Recruitment hospital [6] 0 0
GSK Investigational Site - Milton
Recruitment hospital [7] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [8] 0 0
GSK Investigational Site - Elizabeth Vale
Recruitment hospital [9] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [10] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [11] 0 0
GSK Investigational Site - Nedlands
Recruitment hospital [12] 0 0
GSK Investigational Site - Fremantle
Recruitment hospital [13] 0 0
GSK Investigational Site - Ashford
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4064 - Milton
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
3128 - Box Hill
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment postcode(s) [12] 0 0
6160 - Fremantle
Recruitment postcode(s) [13] 0 0
5035 - Ashford
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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United States of America
State/province [2] 0 0
Alaska
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India
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Stirling

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The TIMI Study Group
Address [1] 0 0
Country [1] 0 0

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 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).
Trial website
https://clinicaltrials.gov/study/NCT01000727
Trial related presentations / publications
Correa S, Morrow DA, Braunwald E, Davies RY, Goodrich EL, Murphy SA, Cannon CP, O'Donoghue ML. Cystatin C for Risk Stratification in Patients After an Acute Coronary Syndrome. J Am Heart Assoc. 2018 Oct 16;7(20):e009077. doi: 10.1161/JAHA.118.009077.
Barger LK, Rajaratnam SMW, Cannon CP, Lukas MA, Im K, Goodrich EL, Czeisler CA, O'Donoghue ML. Short Sleep Duration, Obstructive Sleep Apnea, Shiftwork, and the Risk of Adverse Cardiovascular Events in Patients After an Acute Coronary Syndrome. J Am Heart Assoc. 2017 Oct 10;6(10):e006959. doi: 10.1161/JAHA.117.006959.
Eisen A, Cannon CP, Braunwald E, Steen DL, Zhou J, Goodrich EL, Im K, Dalby AJ, Spinar J, Daga S, Lukas MA, O'Donoghue ML. Predictors of Nonuse of a High-Potency Statin After an Acute Coronary Syndrome: Insights From the Stabilization of Plaques Using Darapladib-Thrombolysis in Myocardial Infarction 52 (SOLID-TIMI 52) Trial. J Am Heart Assoc. 2017 Jan 11;6(1):e004332. doi: 10.1161/JAHA.116.004332.
O'Donoghue ML, Braunwald E, White HD, Lukas MA, Tarka E, Steg PG, Hochman JS, Bode C, Maggioni AP, Im K, Shannon JB, Davies RY, Murphy SA, Crugnale SE, Wiviott SD, Bonaca MP, Watson DF, Weaver WD, Serruys PW, Cannon CP; SOLID-TIMI 52 Investigators; Steen DL. Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1006-15. doi: 10.1001/jama.2014.11061. Erratum In: JAMA. 2014 Oct 8;312(14):1473. Dylan P. Steen[corrected to Dylan L. Steen].
O'Donoghue ML, Braunwald E, White HD, Serruys P, Steg PG, Hochman J, Maggioni AP, Bode C, Weaver D, Johnson JL, Cicconetti G, Lukas MA, Tarka E, Cannon CP. Study design and rationale for the Stabilization of pLaques usIng Darapladib-Thrombolysis in Myocardial Infarction (SOLID-TIMI 52) trial in patients after an acute coronary syndrome. Am Heart J. 2011 Oct;162(4):613-619.e1. doi: 10.1016/j.ahj.2011.07.018. Epub 2011 Sep 15.
Public notes

Contacts
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GSK Clinical Trials
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GlaxoSmithKline
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01000727