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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
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
Secondary ID [1] 0 0
2016-004232-37
Secondary ID [2] 0 0
D5134C00003
Universal Trial Number (UTN)
Trial acronym
THALES
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 - 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of Subsequent Stroke or Death
Timepoint [1] 0 0
From randomisation (day 1) to visit 3 (day 30-34)
Secondary outcome [1] 0 0
Ischaemic Stroke
Timepoint [1] 0 0
From randomisation (day 1) to visit 3 (day 30-34)
Secondary outcome [2] 0 0
Number of Participants With Modified Rankin Scale (mRS) Score >1 at Visit 3
Timepoint [2] 0 0
Visit 3 (day 30-34)

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
Minimum age
40 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

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
22/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/12/2019
Sample size
Target
Accrual to date
Final
11016
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Heidelberg
Recruitment hospital [3] 0 0
Research Site - Herston
Recruitment hospital [4] 0 0
Research Site - Parkville
Recruitment hospital [5] 0 0
Research Site - Southport
Recruitment hospital [6] 0 0
Research Site - St Albans
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Adrogué
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Argentina
State/province [2] 0 0
Buenos Aires
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Argentina
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Capital Federal
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Argentina
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Ciudad Autónoma de Bs. As.
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Argentina
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Cordoba
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Argentina
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Argentina
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Mendoza
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Rosario
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Salta
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Belgium
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Belgium
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Assebroek (Brugge)
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Belgium
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Bruges
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Belgium
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Brussels
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Belgium
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Dendermonde
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Belgium
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Edegem
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Dijon
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Lille
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France
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Paris Cedex 13
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Paris
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Rennes
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Saint Herblain
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Saint-Priez En Jarez
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Suresnes Cedex
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Germany
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Germany
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Germany
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Hungary
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Gyor
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Hungary
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Kistarcsa
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Miskolc
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Nyíregyháza
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Hungary
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Pécs
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Hungary
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Sopron-Balf
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Hungary
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Székesfehérvár
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Hungary
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Tatabánya
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India
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Bangalore
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India
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India
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India
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Guntur
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India
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India
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Kanpur
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Pavia
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Callao
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Trujillo
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Lublin
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Rybnik
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Country [199] 0 0
Poland
State/province [199] 0 0
Zielona Góra
Country [200] 0 0
Poland
State/province [200] 0 0
Lódz
Country [201] 0 0
Poland
State/province [201] 0 0
Swiebodzin
Country [202] 0 0
Romania
State/province [202] 0 0
Bucharest
Country [203] 0 0
Romania
State/province [203] 0 0
Iasi
Country [204] 0 0
Romania
State/province [204] 0 0
Oradea
Country [205] 0 0
Romania
State/province [205] 0 0
Sibiu
Country [206] 0 0
Romania
State/province [206] 0 0
Timisoara
Country [207] 0 0
Romania
State/province [207] 0 0
Tirgu-Mures
Country [208] 0 0
Russian Federation
State/province [208] 0 0
Chelyabinsk
Country [209] 0 0
Russian Federation
State/province [209] 0 0
Ekaterinburg
Country [210] 0 0
Russian Federation
State/province [210] 0 0
Izhevsk
Country [211] 0 0
Russian Federation
State/province [211] 0 0
Kazan
Country [212] 0 0
Russian Federation
State/province [212] 0 0
Kemerovo
Country [213] 0 0
Russian Federation
State/province [213] 0 0
Moscow
Country [214] 0 0
Russian Federation
State/province [214] 0 0
Nizhnii Novgorod
Country [215] 0 0
Russian Federation
State/province [215] 0 0
Nizhniy Novgorod
Country [216] 0 0
Russian Federation
State/province [216] 0 0
Novosibirsk
Country [217] 0 0
Russian Federation
State/province [217] 0 0
Ryazan
Country [218] 0 0
Russian Federation
State/province [218] 0 0
Saint Petersburg
Country [219] 0 0
Russian Federation
State/province [219] 0 0
Saint-Petersburg
Country [220] 0 0
Russian Federation
State/province [220] 0 0
Samara
Country [221] 0 0
Russian Federation
State/province [221] 0 0
Saratov
Country [222] 0 0
Russian Federation
State/province [222] 0 0
Sochi
Country [223] 0 0
Russian Federation
State/province [223] 0 0
Tomsk
Country [224] 0 0
Russian Federation
State/province [224] 0 0
Ufa
Country [225] 0 0
Russian Federation
State/province [225] 0 0
Voronezh
Country [226] 0 0
Russian Federation
State/province [226] 0 0
Yaroslavl
Country [227] 0 0
Saudi Arabia
State/province [227] 0 0
Ar Riya?
Country [228] 0 0
Saudi Arabia
State/province [228] 0 0
Jeddah
Country [229] 0 0
Saudi Arabia
State/province [229] 0 0
Riyadh
Country [230] 0 0
Slovakia
State/province [230] 0 0
Dolny Kubin
Country [231] 0 0
Slovakia
State/province [231] 0 0
Levoca
Country [232] 0 0
Slovakia
State/province [232] 0 0
Liptovsky Mikulas
Country [233] 0 0
Slovakia
State/province [233] 0 0
Martin
Country [234] 0 0
Slovakia
State/province [234] 0 0
Nitra
Country [235] 0 0
Slovakia
State/province [235] 0 0
Rimavska Sobota
Country [236] 0 0
Slovakia
State/province [236] 0 0
Skalica
Country [237] 0 0
Slovakia
State/province [237] 0 0
Spisska Nova Ves
Country [238] 0 0
Slovakia
State/province [238] 0 0
Trencin
Country [239] 0 0
Slovakia
State/province [239] 0 0
Trnava
Country [240] 0 0
Slovakia
State/province [240] 0 0
Ziar nad Hronom
Country [241] 0 0
Spain
State/province [241] 0 0
Albacete
Country [242] 0 0
Spain
State/province [242] 0 0
Alicante
Country [243] 0 0
Spain
State/province [243] 0 0
Badalona(Barcelona)
Country [244] 0 0
Spain
State/province [244] 0 0
Barcelona
Country [245] 0 0
Spain
State/province [245] 0 0
Gerona
Country [246] 0 0
Spain
State/province [246] 0 0
Lleida
Country [247] 0 0
Spain
State/province [247] 0 0
Madrid
Country [248] 0 0
Spain
State/province [248] 0 0
Sevilla
Country [249] 0 0
Spain
State/province [249] 0 0
Valencia
Country [250] 0 0
Spain
State/province [250] 0 0
Valladolid
Country [251] 0 0
Spain
State/province [251] 0 0
Zaragoza
Country [252] 0 0
Sweden
State/province [252] 0 0
Göteborg
Country [253] 0 0
Sweden
State/province [253] 0 0
Linköping
Country [254] 0 0
Sweden
State/province [254] 0 0
Lund
Country [255] 0 0
Sweden
State/province [255] 0 0
Malmö
Country [256] 0 0
Sweden
State/province [256] 0 0
Ostersund
Country [257] 0 0
Sweden
State/province [257] 0 0
Skövde
Country [258] 0 0
Sweden
State/province [258] 0 0
Solna
Country [259] 0 0
Sweden
State/province [259] 0 0
Stockholm
Country [260] 0 0
Sweden
State/province [260] 0 0
Uppsala
Country [261] 0 0
Taiwan
State/province [261] 0 0
Changhua
Country [262] 0 0
Taiwan
State/province [262] 0 0
Kaohsiung City
Country [263] 0 0
Taiwan
State/province [263] 0 0
Kaohsiung
Country [264] 0 0
Taiwan
State/province [264] 0 0
Keelung
Country [265] 0 0
Taiwan
State/province [265] 0 0
New Taipei City
Country [266] 0 0
Taiwan
State/province [266] 0 0
New Taipei
Country [267] 0 0
Taiwan
State/province [267] 0 0
Taichung City
Country [268] 0 0
Taiwan
State/province [268] 0 0
Taichung
Country [269] 0 0
Taiwan
State/province [269] 0 0
Tainan
Country [270] 0 0
Taiwan
State/province [270] 0 0
Taipei
Country [271] 0 0
Taiwan
State/province [271] 0 0
Taoyuan Hsien
Country [272] 0 0
Thailand
State/province [272] 0 0
Bangkok
Country [273] 0 0
Thailand
State/province [273] 0 0
Chonburi
Country [274] 0 0
Thailand
State/province [274] 0 0
Hat Yai
Country [275] 0 0
Thailand
State/province [275] 0 0
Khlong Luang
Country [276] 0 0
Thailand
State/province [276] 0 0
Khon Kaen
Country [277] 0 0
Thailand
State/province [277] 0 0
Lampang
Country [278] 0 0
Thailand
State/province [278] 0 0
Muang
Country [279] 0 0
Thailand
State/province [279] 0 0
Nakhonpathom
Country [280] 0 0
Thailand
State/province [280] 0 0
Prachinburi
Country [281] 0 0
Thailand
State/province [281] 0 0
Rajthevi
Country [282] 0 0
Thailand
State/province [282] 0 0
Ratchaburi
Country [283] 0 0
Thailand
State/province [283] 0 0
Ubonratchathani
Country [284] 0 0
Ukraine
State/province [284] 0 0
Chernivts?
Country [285] 0 0
Ukraine
State/province [285] 0 0
Ivano-Frankivsk
Country [286] 0 0
Ukraine
State/province [286] 0 0
Kharkiv Region
Country [287] 0 0
Ukraine
State/province [287] 0 0
Kherson
Country [288] 0 0
Ukraine
State/province [288] 0 0
Kyiv
Country [289] 0 0
Ukraine
State/province [289] 0 0
Lutsk
Country [290] 0 0
Ukraine
State/province [290] 0 0
Lviv
Country [291] 0 0
Ukraine
State/province [291] 0 0
Poltava
Country [292] 0 0
Ukraine
State/province [292] 0 0
Ternopil
Country [293] 0 0
Ukraine
State/province [293] 0 0
Vinnytsia
Country [294] 0 0
Ukraine
State/province [294] 0 0
Zaporizhzhia
Country [295] 0 0
Vietnam
State/province [295] 0 0
Dong Nai
Country [296] 0 0
Vietnam
State/province [296] 0 0
Ha Noi
Country [297] 0 0
Vietnam
State/province [297] 0 0
Hanoi
Country [298] 0 0
Vietnam
State/province [298] 0 0
Ho Chi Minh City
Country [299] 0 0
Vietnam
State/province [299] 0 0
Ho Chi Minh

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03354429