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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03354429
Registration number
NCT03354429
Ethics application status
Date submitted
20/11/2017
Date registered
28/11/2017
Date last updated
22/12/2020
Titles & IDs
Public title
THALES - Acute STroke or Transient IscHaemic Attack Treated With TicAgreLor and ASA for PrEvention of Stroke and Death
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Scientific title
A Randomised, Double-Blind, Placebo-Controlled, International, Multicentre, Phase III Study to Investigate the Efficacy and Safety of Ticagrelor and ASA Compared With ASA in the Prevention of Stroke and Death in Patients With Acute Ischaemic Stroke or Transient Ischaemic Attack
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Secondary ID [1]
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2016-004232-37
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Secondary ID [2]
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D5134C00003
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Universal Trial Number (UTN)
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Trial acronym
THALES
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Ischaemic Stroke
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Transient Ischaemic Attack
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
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0
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Ischaemic
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ticagrelor
Treatment: Drugs - Placebo
Experimental: TICAGRELOR -
Placebo comparator: TICAGRELOR PLACEBO -
Treatment: Drugs: Ticagrelor
Ticagrelor arm: Day 1, loading dose of ticagrelor followed by daily maintenance dose until Day 30.
Treatment: Drugs: Placebo
Placebo arm: Day 1, loading dose of placebo followed by placebo daily maintenance dose until Day 30.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite of Subsequent Stroke or Death
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Assessment method [1]
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Participants with subsequent stroke or death
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Timepoint [1]
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From randomisation (day 1) to visit 3 (day 30-34)
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Secondary outcome [1]
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Ischaemic Stroke
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Assessment method [1]
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Number of participants with ischaemic stroke
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Timepoint [1]
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From randomisation (day 1) to visit 3 (day 30-34)
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Secondary outcome [2]
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Number of Participants With Modified Rankin Scale (mRS) Score >1 at Visit 3
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Assessment method [2]
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The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.0 - No symptoms,1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
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Timepoint [2]
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Visit 3 (day 30-34)
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Eligibility
Key inclusion criteria
1. Provision of signed informed consent prior to any study-specific procedure
2. =40 years of age
3. Acute onset of cerebral ischaemia due to
1. AIS with NIHSS =5. AIS is defined as acute onset of neurological deficit attributed to focal brain ischaemia, and either of the following:
* Persistent signs or symptoms of the ischaemic event at the time o randomisation, OR
* Acute ischaemic brain lesion documented before randomisation by computed tomography (CT) scan or magnetic resonance imaging (MRI) (diffusion-weighted imaging) and that could account for the clinical presentation
2. High-risk TIA, defined as neurological deficit of acute onset attributed to focal ischaemia of the brain by history or examination with complete resolution of the deficit, and at least one of the following:
* ABCD2 score =6 and TIA symptoms not limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo
* Symptomatic intracranial arterial occlusive disease that could account for the clinical presentation, documented by transcranial Doppler or vascular imaging and defined as at least 50% narrowing in the diameter of the vessel lumen
* Internal carotid arterial occlusive disease that could account for the clinical presentation, documented by Doppler, ultrasound, or vascular imaging and defined as at least 50% narrowing in diameter of the vessel lumen
4. Randomisation occurring within 24 hours after onset of symptoms; for wake-up strokes (when the time of symptom onset is not known), within 24 hours from the time point at which the patient was reported to be in their normal condition
5. CT or MRI performed after symptom onset ruling out intracranial haemorrhage or other pathology, such as vascular malformation, tumour, or abscess that according
to the Investigator could explain symptoms or contraindicate study treatment
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Minimum age
40
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Need for or an anticipated need for any of the following:
1. Dual antiplatelet therapy with ASA and P2Y12 inhibitors (including patients with carotid artery stenting and percutaneous coronary intervention)
2. Antiplatelets other than ASA (eg, GPIIb/IIIa inhibitors, clopidogrel, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol, ticagrelor) and other antithrombotic agents with antiplatelet effects, including traditional/herbal medicine agents
3. Anticoagulants (eg, warfarin, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, fondaparinux, or unfractionated heparin and long-term treatment with low-molecular weight heparins). Short-term treatment (=7 days) with low-dose low-molecular weight heparin may be used in immobilised patients at the discretion of the Investigator
2. Any history of atrial fibrillation/flutter, ventricular aneurysm, or suspicion of other cardioembolic pathology for TIA or stroke
3. Patients who should receive or have received any intravenous or intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation
4. Planned carotid endarterectomy that requires halting investigational product within 3 days of randomisation or is expected to require unblinding of investigational product (planned carotid endarterectomy is in itself not an exclusion criterion)
5. History of previous intracranial haemorrhage at any time (asymptomatic microbleeds do not qualify), gastrointestinal haemorrhage within the past 6 months, or major surgery within 30 days
6. Patients considered to be at risk of bradycardic events (eg, known sick sinus syndrome or second- or third-degree atrioventricular block) unless already treated with a permanent pacemaker
7. Inability of the patient to understand and/or comply with study procedures and/or follow-up, in the opinion of the Investigator
8. Known hypersensitivity to ticagrelor or ASA
9. Need for or an anticipated need for oral or intravenous therapy with any of the following:
1. Strong cytochrome P450 3A (CYP3A4) inhibitors (eg, ketoconazole, clarithromycin [but not erythromycin or azithromycin], nefazadone, ritonavir, atazanavir) that cannot be stopped for the course of the study
2. Long-term (>7 days) non-steroidal anti-inflammatory drugs
10. Known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura)
11. Known severe liver disease (eg, ascites or signs of coagulopathy)
12. Renal failure requiring dialysis
13. Pregnancy or breastfeeding. Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator
14. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
15. Previous enrolment or randomisation in the present study
16. Participation in another clinical study with an investigational product at any time during the 30 days prior to randomisation (regardless of when treatment with the investigational product was discontinued)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/01/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/12/2019
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Sample size
Target
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Accrual to date
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Final
11016
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Adelaide
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment postcode(s) [3]
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4029 - Herston
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3050 - Parkville
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4215 - Southport
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3021 - St Albans
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Recruitment outside Australia
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Argentina
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Germany
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State/province [111]
0
0
Hannover
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Minden
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Münster
Query!
Country [114]
0
0
Hong Kong
Query!
State/province [114]
0
0
Hong Kong
Query!
Country [115]
0
0
Hong Kong
Query!
State/province [115]
0
0
Kowloon
Query!
Country [116]
0
0
Hungary
Query!
State/province [116]
0
0
Baja
Query!
Country [117]
0
0
Hungary
Query!
State/province [117]
0
0
Balassagyarmat
Query!
Country [118]
0
0
Hungary
Query!
State/province [118]
0
0
Budapest
Query!
Country [119]
0
0
Hungary
Query!
State/province [119]
0
0
Debrecen
Query!
Country [120]
0
0
Hungary
Query!
State/province [120]
0
0
Gyor
Query!
Country [121]
0
0
Hungary
Query!
State/province [121]
0
0
Kistarcsa
Query!
Country [122]
0
0
Hungary
Query!
State/province [122]
0
0
Miskolc
Query!
Country [123]
0
0
Hungary
Query!
State/province [123]
0
0
Nyíregyháza
Query!
Country [124]
0
0
Hungary
Query!
State/province [124]
0
0
Pécs
Query!
Country [125]
0
0
Hungary
Query!
State/province [125]
0
0
Sopron-Balf
Query!
Country [126]
0
0
Hungary
Query!
State/province [126]
0
0
Székesfehérvár
Query!
Country [127]
0
0
Hungary
Query!
State/province [127]
0
0
Tatabánya
Query!
Country [128]
0
0
India
Query!
State/province [128]
0
0
Bangalore
Query!
Country [129]
0
0
India
Query!
State/province [129]
0
0
Bengaluru
Query!
Country [130]
0
0
India
Query!
State/province [130]
0
0
Dehradun
Query!
Country [131]
0
0
India
Query!
State/province [131]
0
0
Guntur
Query!
Country [132]
0
0
India
Query!
State/province [132]
0
0
Gurgaon
Query!
Country [133]
0
0
India
Query!
State/province [133]
0
0
Hyderabad
Query!
Country [134]
0
0
India
Query!
State/province [134]
0
0
Kanpur
Query!
Country [135]
0
0
India
Query!
State/province [135]
0
0
Kolkata
Query!
Country [136]
0
0
India
Query!
State/province [136]
0
0
Mangalore
Query!
Country [137]
0
0
India
Query!
State/province [137]
0
0
Nagpur
Query!
Country [138]
0
0
India
Query!
State/province [138]
0
0
Nashik
Query!
Country [139]
0
0
India
Query!
State/province [139]
0
0
New Delhi
Query!
Country [140]
0
0
India
Query!
State/province [140]
0
0
Srikakulam
Query!
Country [141]
0
0
India
Query!
State/province [141]
0
0
Varanasi
Query!
Country [142]
0
0
Italy
Query!
State/province [142]
0
0
Cona
Query!
Country [143]
0
0
Italy
Query!
State/province [143]
0
0
Genova
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Massa
Query!
Country [145]
0
0
Italy
Query!
State/province [145]
0
0
Milano
Query!
Country [146]
0
0
Italy
Query!
State/province [146]
0
0
Modena
Query!
Country [147]
0
0
Italy
Query!
State/province [147]
0
0
Negrar
Query!
Country [148]
0
0
Italy
Query!
State/province [148]
0
0
Pavia
Query!
Country [149]
0
0
Italy
Query!
State/province [149]
0
0
Perugia
Query!
Country [150]
0
0
Italy
Query!
State/province [150]
0
0
Pietra Ligure
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Pisa
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
Roma
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Siena
Query!
Country [154]
0
0
Italy
Query!
State/province [154]
0
0
Varese
Query!
Country [155]
0
0
Italy
Query!
State/province [155]
0
0
Verona
Query!
Country [156]
0
0
Italy
Query!
State/province [156]
0
0
Vicenza
Query!
Country [157]
0
0
Italy
Query!
State/province [157]
0
0
Vizzolo Predabissi
Query!
Country [158]
0
0
Korea, Republic of
Query!
State/province [158]
0
0
Anyang-si
Query!
Country [159]
0
0
Korea, Republic of
Query!
State/province [159]
0
0
Busan
Query!
Country [160]
0
0
Korea, Republic of
Query!
State/province [160]
0
0
Cheongju-si
Query!
Country [161]
0
0
Korea, Republic of
Query!
State/province [161]
0
0
Daegu
Query!
Country [162]
0
0
Korea, Republic of
Query!
State/province [162]
0
0
Daejeon-si
Query!
Country [163]
0
0
Korea, Republic of
Query!
State/province [163]
0
0
Goyang-si
Query!
Country [164]
0
0
Korea, Republic of
Query!
State/province [164]
0
0
Gwangju
Query!
Country [165]
0
0
Korea, Republic of
Query!
State/province [165]
0
0
Incheon
Query!
Country [166]
0
0
Korea, Republic of
Query!
State/province [166]
0
0
Jeju-do
Query!
Country [167]
0
0
Korea, Republic of
Query!
State/province [167]
0
0
Seongnam-si
Query!
Country [168]
0
0
Korea, Republic of
Query!
State/province [168]
0
0
Seoul
Query!
Country [169]
0
0
Mexico
Query!
State/province [169]
0
0
Culiacan
Query!
Country [170]
0
0
Mexico
Query!
State/province [170]
0
0
D.F
Query!
Country [171]
0
0
Mexico
Query!
State/province [171]
0
0
Durango
Query!
Country [172]
0
0
Mexico
Query!
State/province [172]
0
0
Guadalajara
Query!
Country [173]
0
0
Mexico
Query!
State/province [173]
0
0
Mexico City
Query!
Country [174]
0
0
Mexico
Query!
State/province [174]
0
0
Mexico
Query!
Country [175]
0
0
Mexico
Query!
State/province [175]
0
0
Monterrey
Query!
Country [176]
0
0
Mexico
Query!
State/province [176]
0
0
México
Query!
Country [177]
0
0
Mexico
Query!
State/province [177]
0
0
Tijuana
Query!
Country [178]
0
0
Peru
Query!
State/province [178]
0
0
Bellavista
Query!
Country [179]
0
0
Peru
Query!
State/province [179]
0
0
Callao
Query!
Country [180]
0
0
Peru
Query!
State/province [180]
0
0
Lima
Query!
Country [181]
0
0
Peru
Query!
State/province [181]
0
0
Trujillo
Query!
Country [182]
0
0
Peru
Query!
State/province [182]
0
0
Urb. El Chipe
Query!
Country [183]
0
0
Poland
Query!
State/province [183]
0
0
Bialystok
Query!
Country [184]
0
0
Poland
Query!
State/province [184]
0
0
Chelm
Query!
Country [185]
0
0
Poland
Query!
State/province [185]
0
0
Dzialdowo
Query!
Country [186]
0
0
Poland
Query!
State/province [186]
0
0
Gdansk
Query!
Country [187]
0
0
Poland
Query!
State/province [187]
0
0
Grodzisk Mazowiecki
Query!
Country [188]
0
0
Poland
Query!
State/province [188]
0
0
Gryfice
Query!
Country [189]
0
0
Poland
Query!
State/province [189]
0
0
Katowice
Query!
Country [190]
0
0
Poland
Query!
State/province [190]
0
0
Konskie
Query!
Country [191]
0
0
Poland
Query!
State/province [191]
0
0
Kraków
Query!
Country [192]
0
0
Poland
Query!
State/province [192]
0
0
Lublin
Query!
Country [193]
0
0
Poland
Query!
State/province [193]
0
0
Olsztyn
Query!
Country [194]
0
0
Poland
Query!
State/province [194]
0
0
Ostroleka
Query!
Country [195]
0
0
Poland
Query!
State/province [195]
0
0
Rybnik
Query!
Country [196]
0
0
Poland
Query!
State/province [196]
0
0
Sandomierz
Query!
Country [197]
0
0
Poland
Query!
State/province [197]
0
0
Skarzysko-Kamienna
Query!
Country [198]
0
0
Poland
Query!
State/province [198]
0
0
Warszawa
Query!
Country [199]
0
0
Poland
Query!
State/province [199]
0
0
Zielona Góra
Query!
Country [200]
0
0
Poland
Query!
State/province [200]
0
0
Lódz
Query!
Country [201]
0
0
Poland
Query!
State/province [201]
0
0
Swiebodzin
Query!
Country [202]
0
0
Romania
Query!
State/province [202]
0
0
Bucharest
Query!
Country [203]
0
0
Romania
Query!
State/province [203]
0
0
Iasi
Query!
Country [204]
0
0
Romania
Query!
State/province [204]
0
0
Oradea
Query!
Country [205]
0
0
Romania
Query!
State/province [205]
0
0
Sibiu
Query!
Country [206]
0
0
Romania
Query!
State/province [206]
0
0
Timisoara
Query!
Country [207]
0
0
Romania
Query!
State/province [207]
0
0
Tirgu-Mures
Query!
Country [208]
0
0
Russian Federation
Query!
State/province [208]
0
0
Chelyabinsk
Query!
Country [209]
0
0
Russian Federation
Query!
State/province [209]
0
0
Ekaterinburg
Query!
Country [210]
0
0
Russian Federation
Query!
State/province [210]
0
0
Izhevsk
Query!
Country [211]
0
0
Russian Federation
Query!
State/province [211]
0
0
Kazan
Query!
Country [212]
0
0
Russian Federation
Query!
State/province [212]
0
0
Kemerovo
Query!
Country [213]
0
0
Russian Federation
Query!
State/province [213]
0
0
Moscow
Query!
Country [214]
0
0
Russian Federation
Query!
State/province [214]
0
0
Nizhnii Novgorod
Query!
Country [215]
0
0
Russian Federation
Query!
State/province [215]
0
0
Nizhniy Novgorod
Query!
Country [216]
0
0
Russian Federation
Query!
State/province [216]
0
0
Novosibirsk
Query!
Country [217]
0
0
Russian Federation
Query!
State/province [217]
0
0
Ryazan
Query!
Country [218]
0
0
Russian Federation
Query!
State/province [218]
0
0
Saint Petersburg
Query!
Country [219]
0
0
Russian Federation
Query!
State/province [219]
0
0
Saint-Petersburg
Query!
Country [220]
0
0
Russian Federation
Query!
State/province [220]
0
0
Samara
Query!
Country [221]
0
0
Russian Federation
Query!
State/province [221]
0
0
Saratov
Query!
Country [222]
0
0
Russian Federation
Query!
State/province [222]
0
0
Sochi
Query!
Country [223]
0
0
Russian Federation
Query!
State/province [223]
0
0
Tomsk
Query!
Country [224]
0
0
Russian Federation
Query!
State/province [224]
0
0
Ufa
Query!
Country [225]
0
0
Russian Federation
Query!
State/province [225]
0
0
Voronezh
Query!
Country [226]
0
0
Russian Federation
Query!
State/province [226]
0
0
Yaroslavl
Query!
Country [227]
0
0
Saudi Arabia
Query!
State/province [227]
0
0
Ar Riya?
Query!
Country [228]
0
0
Saudi Arabia
Query!
State/province [228]
0
0
Jeddah
Query!
Country [229]
0
0
Saudi Arabia
Query!
State/province [229]
0
0
Riyadh
Query!
Country [230]
0
0
Slovakia
Query!
State/province [230]
0
0
Dolny Kubin
Query!
Country [231]
0
0
Slovakia
Query!
State/province [231]
0
0
Levoca
Query!
Country [232]
0
0
Slovakia
Query!
State/province [232]
0
0
Liptovsky Mikulas
Query!
Country [233]
0
0
Slovakia
Query!
State/province [233]
0
0
Martin
Query!
Country [234]
0
0
Slovakia
Query!
State/province [234]
0
0
Nitra
Query!
Country [235]
0
0
Slovakia
Query!
State/province [235]
0
0
Rimavska Sobota
Query!
Country [236]
0
0
Slovakia
Query!
State/province [236]
0
0
Skalica
Query!
Country [237]
0
0
Slovakia
Query!
State/province [237]
0
0
Spisska Nova Ves
Query!
Country [238]
0
0
Slovakia
Query!
State/province [238]
0
0
Trencin
Query!
Country [239]
0
0
Slovakia
Query!
State/province [239]
0
0
Trnava
Query!
Country [240]
0
0
Slovakia
Query!
State/province [240]
0
0
Ziar nad Hronom
Query!
Country [241]
0
0
Spain
Query!
State/province [241]
0
0
Albacete
Query!
Country [242]
0
0
Spain
Query!
State/province [242]
0
0
Alicante
Query!
Country [243]
0
0
Spain
Query!
State/province [243]
0
0
Badalona(Barcelona)
Query!
Country [244]
0
0
Spain
Query!
State/province [244]
0
0
Barcelona
Query!
Country [245]
0
0
Spain
Query!
State/province [245]
0
0
Gerona
Query!
Country [246]
0
0
Spain
Query!
State/province [246]
0
0
Lleida
Query!
Country [247]
0
0
Spain
Query!
State/province [247]
0
0
Madrid
Query!
Country [248]
0
0
Spain
Query!
State/province [248]
0
0
Sevilla
Query!
Country [249]
0
0
Spain
Query!
State/province [249]
0
0
Valencia
Query!
Country [250]
0
0
Spain
Query!
State/province [250]
0
0
Valladolid
Query!
Country [251]
0
0
Spain
Query!
State/province [251]
0
0
Zaragoza
Query!
Country [252]
0
0
Sweden
Query!
State/province [252]
0
0
Göteborg
Query!
Country [253]
0
0
Sweden
Query!
State/province [253]
0
0
Linköping
Query!
Country [254]
0
0
Sweden
Query!
State/province [254]
0
0
Lund
Query!
Country [255]
0
0
Sweden
Query!
State/province [255]
0
0
Malmö
Query!
Country [256]
0
0
Sweden
Query!
State/province [256]
0
0
Ostersund
Query!
Country [257]
0
0
Sweden
Query!
State/province [257]
0
0
Skövde
Query!
Country [258]
0
0
Sweden
Query!
State/province [258]
0
0
Solna
Query!
Country [259]
0
0
Sweden
Query!
State/province [259]
0
0
Stockholm
Query!
Country [260]
0
0
Sweden
Query!
State/province [260]
0
0
Uppsala
Query!
Country [261]
0
0
Taiwan
Query!
State/province [261]
0
0
Changhua
Query!
Country [262]
0
0
Taiwan
Query!
State/province [262]
0
0
Kaohsiung City
Query!
Country [263]
0
0
Taiwan
Query!
State/province [263]
0
0
Kaohsiung
Query!
Country [264]
0
0
Taiwan
Query!
State/province [264]
0
0
Keelung
Query!
Country [265]
0
0
Taiwan
Query!
State/province [265]
0
0
New Taipei City
Query!
Country [266]
0
0
Taiwan
Query!
State/province [266]
0
0
New Taipei
Query!
Country [267]
0
0
Taiwan
Query!
State/province [267]
0
0
Taichung City
Query!
Country [268]
0
0
Taiwan
Query!
State/province [268]
0
0
Taichung
Query!
Country [269]
0
0
Taiwan
Query!
State/province [269]
0
0
Tainan
Query!
Country [270]
0
0
Taiwan
Query!
State/province [270]
0
0
Taipei
Query!
Country [271]
0
0
Taiwan
Query!
State/province [271]
0
0
Taoyuan Hsien
Query!
Country [272]
0
0
Thailand
Query!
State/province [272]
0
0
Bangkok
Query!
Country [273]
0
0
Thailand
Query!
State/province [273]
0
0
Chonburi
Query!
Country [274]
0
0
Thailand
Query!
State/province [274]
0
0
Hat Yai
Query!
Country [275]
0
0
Thailand
Query!
State/province [275]
0
0
Khlong Luang
Query!
Country [276]
0
0
Thailand
Query!
State/province [276]
0
0
Khon Kaen
Query!
Country [277]
0
0
Thailand
Query!
State/province [277]
0
0
Lampang
Query!
Country [278]
0
0
Thailand
Query!
State/province [278]
0
0
Muang
Query!
Country [279]
0
0
Thailand
Query!
State/province [279]
0
0
Nakhonpathom
Query!
Country [280]
0
0
Thailand
Query!
State/province [280]
0
0
Prachinburi
Query!
Country [281]
0
0
Thailand
Query!
State/province [281]
0
0
Rajthevi
Query!
Country [282]
0
0
Thailand
Query!
State/province [282]
0
0
Ratchaburi
Query!
Country [283]
0
0
Thailand
Query!
State/province [283]
0
0
Ubonratchathani
Query!
Country [284]
0
0
Ukraine
Query!
State/province [284]
0
0
Chernivts?
Query!
Country [285]
0
0
Ukraine
Query!
State/province [285]
0
0
Ivano-Frankivsk
Query!
Country [286]
0
0
Ukraine
Query!
State/province [286]
0
0
Kharkiv Region
Query!
Country [287]
0
0
Ukraine
Query!
State/province [287]
0
0
Kherson
Query!
Country [288]
0
0
Ukraine
Query!
State/province [288]
0
0
Kyiv
Query!
Country [289]
0
0
Ukraine
Query!
State/province [289]
0
0
Lutsk
Query!
Country [290]
0
0
Ukraine
Query!
State/province [290]
0
0
Lviv
Query!
Country [291]
0
0
Ukraine
Query!
State/province [291]
0
0
Poltava
Query!
Country [292]
0
0
Ukraine
Query!
State/province [292]
0
0
Ternopil
Query!
Country [293]
0
0
Ukraine
Query!
State/province [293]
0
0
Vinnytsia
Query!
Country [294]
0
0
Ukraine
Query!
State/province [294]
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Zaporizhzhia
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Country [295]
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Vietnam
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State/province [295]
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Dong Nai
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Country [296]
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Vietnam
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State/province [296]
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Ha Noi
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Country [297]
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Vietnam
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Hanoi
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Country [298]
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Vietnam
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Ho Chi Minh City
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Country [299]
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Vietnam
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State/province [299]
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
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Summary
Brief summary
Study to investigate if the study drug ticagrelor and ASA is more effective than Placebo (inactive tablet) and ASA in preventing new stroke events
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Trial website
https://clinicaltrials.gov/study/NCT03354429
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Trial related presentations / publications
Johnston SC, Amarenco P, Aunes M, Denison H, Evans SR, Himmelmann A, Jahreskog M, James S, Knutsson M, Ladenvall P, Molina CA, Nylander S, Rother J, Wang Y; THALES Investigators. Ischemic Benefit and Hemorrhage Risk of Ticagrelor-Aspirin Versus Aspirin in Patients With Acute Ischemic Stroke or Transient Ischemic Attack. Stroke. 2021 Nov;52(11):3482-3489. doi: 10.1161/STROKEAHA.121.035555. Epub 2021 Sep 3. Wang Y, Pan Y, Li H, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Birve F, Ladenvall P, Molina CA, Johnston SC; THALES Steering Committee and Investigators. Efficacy and Safety of Ticagrelor and Aspirin in Patients With Moderate Ischemic Stroke: An Exploratory Analysis of the THALES Randomized Clinical Trial. JAMA Neurol. 2021 Sep 1;78(9):1091-1098. doi: 10.1001/jamaneurol.2021.2440. Yaghi S, de Havenon A, Rostanski S, Kvernland A, Mac Grory B, Furie KL, Kim AS, Easton JD, Johnston SC, Henninger N. Carotid Stenosis and Recurrent Ischemic Stroke: A Post-Hoc Analysis of the POINT Trial. Stroke. 2021 Jul;52(7):2414-2417. doi: 10.1161/STROKEAHA.121.034089. Epub 2021 May 4. Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y, Johnston SC; THALES Steering Committee and Investigators*. Ticagrelor Added to Aspirin in Acute Nonsevere Ischemic Stroke or Transient Ischemic Attack of Atherosclerotic Origin. Stroke. 2020 Dec;51(12):3504-3513. doi: 10.1161/STROKEAHA.120.032239. Epub 2020 Nov 16. Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y, Johnston SC; THALES Steering Committee and Investigators. Ticagrelor Added to Aspirin in Acute Ischemic Stroke or Transient Ischemic Attack in Prevention of Disabling Stroke: A Randomized Clinical Trial. JAMA Neurol. 2020 Nov 7;78(2):1-9. doi: 10.1001/jamaneurol.2020.4396. Online ahead of print. Erratum In: JAMA Neurol. 2021 Feb 1;78(2):253. doi: 10.1001/jamaneurol.2020.4906. Johnston SC, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y; THALES Investigators. Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA. N Engl J Med. 2020 Jul 16;383(3):207-217. doi: 10.1056/NEJMoa1916870. Johnston SC, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y; THALES Investigators. The Acute Stroke or Transient Ischemic Attack Treated with Ticagrelor and Aspirin for Prevention of Stroke and Death (THALES) trial: Rationale and design. Int J Stroke. 2019 Oct;14(7):745-751. doi: 10.1177/1747493019830307. Epub 2019 Feb 12. 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.
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Public notes
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Contacts
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/29/NCT03354429/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/29/NCT03354429/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03354429
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