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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01994720




Registration number
NCT01994720
Ethics application status
Date submitted
18/11/2013
Date registered
26/11/2013
Date last updated
12/06/2017

Titles & IDs
Public title
[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]
Scientific title
A Randomised, Double-Blind, Multinational Study to Prevent Major Vascular Events With Ticagrelor Compared to Aspirin (ASA) in Patients With Acute Ischaemic Stroke or TIA.
Secondary ID [1] 0 0
2012-003895-38
Secondary ID [2] 0 0
D5134C00001
Universal Trial Number (UTN)
Trial acronym
SOCRATES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischaemic Stroke 0 0
Transient Ischaemic Attack 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ticagrelor
Treatment: Drugs - Acetylsalicylic acid (ASA)

Experimental: ticagrelor -

Active comparator: Acetylsalicylic acid (ASA) -


Treatment: Drugs: ticagrelor
ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily.

Treatment: Drugs: Acetylsalicylic acid (ASA)
ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Composite of Stroke/MI/Death
Timepoint [1] 0 0
From randomization up to 97 days
Secondary outcome [1] 0 0
Number of Participants With Ischaemic Stroke
Timepoint [1] 0 0
From randomization up to 97 days
Secondary outcome [2] 0 0
Net Clinical Outcome
Timepoint [2] 0 0
From randomization up to 97 days
Secondary outcome [3] 0 0
Number of Participants With Composite of Ischaemic Stroke, MI and CV Death
Timepoint [3] 0 0
From randomization up to 97 days
Secondary outcome [4] 0 0
Number of Participants With All-Cause Death
Timepoint [4] 0 0
From randomization up to 97 days
Secondary outcome [5] 0 0
Number of Participants With CV Death
Timepoint [5] 0 0
From randomization up to 97 days
Secondary outcome [6] 0 0
Number of Participants With MI
Timepoint [6] 0 0
From randomization up to 97 days
Secondary outcome [7] 0 0
Number of Participants by Severity of Stroke and Overall Disability
Timepoint [7] 0 0
From randomization up to 97 days
Secondary outcome [8] 0 0
Number of Participants With Stroke
Timepoint [8] 0 0
From randomization up to 97 days
Secondary outcome [9] 0 0
Number of Participants With Fatal Stroke
Timepoint [9] 0 0
From randomization up to 97 days
Secondary outcome [10] 0 0
Number of Participants With Disabling Stroke
Timepoint [10] 0 0
From randomization up to 97 days
Secondary outcome [11] 0 0
Change in NIHSS
Timepoint [11] 0 0
From randomization up to 97 days
Secondary outcome [12] 0 0
EQ-5D at Visit 1 (Enrolment)
Timepoint [12] 0 0
Visit 1 (Enrolment)
Secondary outcome [13] 0 0
EQ-5D at Visit 2 (Day 7+-2d)
Timepoint [13] 0 0
Visit 2 (Day 7+-2d)
Secondary outcome [14] 0 0
EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit
Timepoint [14] 0 0
End of treatment visit (Day 90+-7d)
Secondary outcome [15] 0 0
EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit
Timepoint [15] 0 0
Premature treatment discontinuation visit(<15 days after last dose)
Secondary outcome [16] 0 0
Number of Participants With PLATO Major Bleeding Event
Timepoint [16] 0 0
From randomization up to 97 days
Secondary outcome [17] 0 0
Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event
Timepoint [17] 0 0
Time from first dose and up to and including 7 days following the date of last dose of the study

Eligibility
Key inclusion criteria
* Men or women equal or elder 40 years of age
* Either acute ischaemic stroke or high-risk TIA as defined here and randomisation occurring within 24 hours after onset of symptoms

Key
Minimum age
40 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Planned use of antithrombotic therapy in addition to study medication including antiplatelets (eg, open label ASA, GPIIb/IIIa inhibitors, clopidogrel, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol) and anticoagulants (eg, warfarin, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, unfractionated and low molecular weight heparins). - Any history of atrial fibrillation, ventricular aneurysm or suspicion of cardioembolic pathology for TIA or stroke. - Planned carotid, cerebrovascular, or coronary revascularisation that requires halting study medication within 7 days of randomisation. - Receipt of any intravenous or intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation - History of previous symptomatic non-traumatic intracerebral bleed at any time (asymptomatic microbleeds do not qualify), gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days.

Study design
Purpose of the study
Prevention
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 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
7/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/03/2016
Sample size
Target
Accrual to date
Final
13307
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Bedford Park
Recruitment hospital [3] 0 0
Research Site - Camperdown
Recruitment hospital [4] 0 0
Research Site - Clayton
Recruitment hospital [5] 0 0
Research Site - Darlinghurst
Recruitment hospital [6] 0 0
Research Site - Footscray
Recruitment hospital [7] 0 0
Research Site - Herston
Recruitment hospital [8] 0 0
Research Site - New Lambton Heights
Recruitment hospital [9] 0 0
Research Site - Parkville
Recruitment hospital [10] 0 0
Research Site - Southport
Recruitment hospital [11] 0 0
Research Site - Sydney
Recruitment hospital [12] 0 0
Research Site - Woodville
Recruitment postcode(s) [1] 0 0
- Adelaide
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- Bedford Park
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- Camperdown
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- Clayton
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- Darlinghurst
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- Footscray
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- Herston
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- New Lambton Heights
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- Parkville
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- Southport
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- Sydney
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- Woodville
Recruitment outside Australia
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United States of America
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Hochiminh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg \[two 90 mg tablets\] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg \[three 100 mg tablets\] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction \[MI\], and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).
Trial website
https://clinicaltrials.gov/study/NCT01994720
Trial related presentations / publications
Diener HC, Easton JD, Hart RG, Kasner S, Kamel H, Ntaios G. Review and update of the concept of embolic stroke of undetermined source. Nat Rev Neurol. 2022 Aug;18(8):455-465. doi: 10.1038/s41582-022-00663-4. Epub 2022 May 10.
Evans SR, Knutsson M, Amarenco P, Albers GW, Bath PM, Denison H, Ladenvall P, Jonasson J, Easton JD, Minematsu K, Molina CA, Wang Y, Wong KL, Johnston SC. Methodologies for pragmatic and efficient assessment of benefits and harms: Application to the SOCRATES trial. Clin Trials. 2020 Dec;17(6):617-626. doi: 10.1177/1740774520941441. Epub 2020 Jul 15.
Cucchiara B, George DK, Kasner SE, Knutsson M, Denison H, Ladenvall P, Amarenco P, Johnston SC. Disability after minor stroke and TIA: A secondary analysis of the SOCRATES trial. Neurology. 2019 Aug 13;93(7):e708-e716. doi: 10.1212/WNL.0000000000007936. Epub 2019 Jul 11.
Easton JD, Denison H, Evans SR, Knutsson M, Amarenco P, Albers GW, Ladenvall P, Minematsu K, Molina CA, Wang Y, Wong KL, Johnston SC; SOCRATES Steering Committee and Investigators. Estimated treatment effect of ticagrelor versus aspirin by investigator-assessed events compared with judgement by an independent event adjudication committee in the SOCRATES trial. Int J Stroke. 2019 Dec;14(9):908-914. doi: 10.1177/1747493019851282. Epub 2019 May 15.
Molina CA, Johnston SC, Ladenvall P, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Knutsson M, Minematsu K, Rother J, Wang Y, Wong KSL; SOCRATES Steering Committee and Investigators. Time to Loading Dose and Risk of Recurrent Events in the SOCRATES Trial. Stroke. 2019 Mar;50(3):675-682. doi: 10.1161/STROKEAHA.118.022675. Erratum In: Stroke. 2019 Apr;50(4):e118. doi: 10.1161/STR.0000000000000186.
Wong KSL, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Himmelmann A, Kasner SE, Knutsson M, Ladenvall P, Minematsu K, Molina CA, Wang Y, Johnston SC; SOCRATES Steering Committee and Investigators. Efficacy and Safety of Ticagrelor in Relation to Aspirin Use Within the Week Before Randomization in the SOCRATES Trial. Stroke. 2018 Jul;49(7):1678-1685. doi: 10.1161/STROKEAHA.118.020553. Epub 2018 Jun 18.
Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Hill MD, Jonasson J, Kasner SE, Ladenvall P, Minematsu K, Molina CA, Wang Y, Wong KSL, Johnston SC; SOCRATES Steering Committee and Investigators. Ticagrelor Versus Aspirin in Acute Embolic Stroke of Undetermined Source. Stroke. 2017 Sep;48(9):2480-2487. doi: 10.1161/STROKEAHA.117.017217. Epub 2017 Jul 18.
Easton JD, Aunes M, Albers GW, Amarenco P, Bokelund-Singh S, Denison H, Evans SR, Held P, Jahreskog M, Jonasson J, Minematsu K, Molina CA, Wang Y, Wong KSL, Johnston SC; SOCRATES Steering Committee and Investigators. Risk for Major Bleeding in Patients Receiving Ticagrelor Compared With Aspirin After Transient Ischemic Attack or Acute Ischemic Stroke in the SOCRATES Study (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes). Circulation. 2017 Sep 5;136(10):907-916. doi: 10.1161/CIRCULATIONAHA.117.028566. Epub 2017 Jun 27.
Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Hill MD, Jonasson J, Kasner SE, Ladenvall P, Minematsu K, Molina CA, Wang Y, Wong KSL, Johnston SC; SOCRATES Steering Committee and Investigators. Efficacy and safety of ticagrelor versus aspirin in acute stroke or transient ischaemic attack of atherosclerotic origin: a subgroup analysis of SOCRATES, a randomised, double-blind, controlled trial. Lancet Neurol. 2017 Apr;16(4):301-310. doi: 10.1016/S1474-4422(17)30038-8. Epub 2017 Feb 23.
Wang Y, Minematsu K, Wong KS, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Jonasson J, Molina CA, Johnston SC; SOCRATES Steering Committee and Investigators. Ticagrelor in Acute Stroke or Transient Ischemic Attack in Asian Patients: From the SOCRATES Trial (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes). Stroke. 2017 Jan;48(1):167-173. doi: 10.1161/STROKEAHA.116.014891. Epub 2016 Nov 29.
Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.
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Public notes

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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01994720