THALES - Acute STroke or Transient IscHaemic Attack Treated With TicAgreLor and ASA for PrEvention of Stroke and Death (THALES)

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

Study to investigate if the study drug ticagrelor and ASA is more effective than Placebo (inactive tablet) and ASA in preventing new stroke events

Study Overview

• Status: Completed
• Conditions: Acute Ischaemic Stroke; Transient Ischaemic Attack
• Intervention / Treatment: Drug: Ticagrelor; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 11016
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Adrogué, Argentina, 1846
    • Research Site
  • Buenos Aires, Argentina, 1180AAX
    • Research Site
  • Buenos Aires, Argentina, 1437
    • Research Site
  • Buenos Aires, Argentina, AR-CP 1221
    • Research Site
  • Buenos Aires, Argentina, C1425 FSD
    • Research Site
  • Buenos Aires, Argentina, C1437BZK
    • Research Site
  • Capital Federal, Argentina, 1428
    • Research Site
  • Ciudad Autónoma de Bs. As., Argentina, C1199ABB
    • Research Site
  • Cordoba, Argentina, 5000
    • Research Site
  • Mar del Plata, Argentina, B7602CBM
    • Research Site
  • Mendoza, Argentina, M5500IDN
    • Research Site
  • Rosario, Argentina, S2000DSV
    • Research Site
  • Rosario, Argentina, S200GAP
    • Research Site
  • Salta, Argentina, A4400
    • Research Site
• Australia
  • Adelaide, Australia, 5000
    • Research Site
  • Heidelberg, Australia, 3084
    • Research Site
  • Herston, Australia, 4029
    • Research Site
  • Parkville, Australia, 3050
    • Research Site
  • Southport, Australia, 4215
    • Research Site
  • St Albans, Australia, 3021
    • Research Site
• Belgium
  • Antwerpen, Belgium, 2020
    • Research Site
  • Assebroek (Brugge), Belgium, 8310
    • Research Site
  • Bruges, Belgium, 8000
    • Research Site
  • Brussels, Belgium, 1200
    • Research Site
  • Dendermonde, Belgium, 9200
    • Research Site
  • Edegem, Belgium, 2650
    • Research Site
  • Kortrijk, Belgium, 8500
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
  • Liège, Belgium, 4000
    • Research Site
  • Oostende, Belgium, 8400
    • Research Site
  • Roeselare, Belgium, 8800
    • Research Site
  • Sint-Truiden, Belgium, 3800
    • Research Site
  • Yvoir, Belgium, 5530
    • Research Site
• Brazil
  • Botucatu, Brazil, 18618-687
    • Research Site
  • Curitiba, Brazil, 81210-310
    • Research Site
  • Goiania, Brazil, 74083-100
    • Research Site
  • Joinville, Brazil, 89202-165
    • Research Site
  • Maringa, Brazil, 87015-000
    • Research Site
  • Porto Alegre, Brazil, 90610-000
    • Research Site
  • Ribeirao Preto, Brazil, 14015130
    • Research Site
  • Rio de Janeiro, Brazil, 22270-005
    • Research Site
  • Salvador, Brazil, 41820011
    • Research Site
• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • Research Site
  • Kozloduy, Bulgaria, 3320
    • Research Site
  • Lukovit, Bulgaria, 5770
    • Research Site
  • Pazardzhik, Bulgaria, 4400
    • Research Site
  • Pleven, Bulgaria, 5800
    • Research Site
  • Sliven, Bulgaria, 8800
    • Research Site
  • Sofia, Bulgaria, 1407
    • Research Site
  • Sofia, Bulgaria, 1142
    • Research Site
  • Sofia, Bulgaria, 1606
    • Research Site
  • Teteven, Bulgaria, 5700
    • Research Site
• Canada
  • Chicoutimi, Canada, G7H 5H6
    • Research Site
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Research Site
    • Edmonton, Alberta, Canada, T6G 2B7
      • Research Site
    • Lethbridge, Alberta, Canada, T1J 0N9
      • Research Site
• China
  • Baoji, China, 721008
    • Research Site
  • Baotou, China, 014016
    • Research Site
  • Beijing, China, 100070
    • Research Site
  • Beijing, China, 100191
    • Research Site
  • Beijing, China, 100049
    • Research Site
  • Changsha, China, 410013
    • Research Site
  • Changsha, China, 430033
    • Research Site
  • Changsha, China, 410078
    • Research Site
  • Chifeng, China, 024000
    • Research Site
  • Daqing, China, 163000
    • Research Site
  • Foshan, China, 528000
    • Research Site
  • Guangzhou, China, 510080
    • Research Site
  • Guangzhou, China, 510180
    • Research Site
  • Guangzhou, China, 510630
    • Research Site
  • Guiyang, China, 550004
    • Research Site
  • Haikou, China, 570311
    • Research Site
  • Hangzhou, China, 310009
    • Research Site
  • Hohhot, China, 010017
    • Research Site
  • Hohhot, China, 10050
    • Research Site
  • Jinan, China, 250001
    • Research Site
  • Jinzhou, China, 121004
    • Research Site
  • Liuzhou, China, 545006
    • Research Site
  • Nanchang, China, 330006
    • Research Site
  • Nanjing, China, 210029
    • Research Site
  • Nantong, China, 226001
    • Research Site
  • Ningbo, China, 315010
    • Research Site
  • Shanghai, China, 200080
    • Research Site
  • Shanghai, China, 200090
    • Research Site
  • Shanghai, China, CN-200120
    • Research Site
  • Shenyang, China, 110016
    • Research Site
  • Taiyuan, China, 030001
    • Research Site
  • Tangshan, China, 063001
    • Research Site
  • Tianjin, China, 300060
    • Research Site
  • Tianjin, China, 300121
    • Research Site
  • Wenzhou, China, 325000
    • Research Site
  • Wu Han, China, 430060
    • Research Site
  • Wuhan, China, 430022
    • Research Site
  • Wuhan, China, 430033
    • Research Site
  • Wuxi, China, 214002
    • Research Site
  • Xi'an, China, 710061
    • Research Site
  • Xiamen, China, 361004
    • Research Site
  • Xining, China, 810001
    • Research Site
  • Xuzhou, China, 221006
    • Research Site
• Czechia
  • Brno, Czechia, 656 91
    • Research Site
  • Chomutov, Czechia, 430 12
    • Research Site
  • Ostrava, Czechia, 708 52
    • Research Site
  • Ostrava, Czechia, 703 84
    • Research Site
  • Pardubice, Czechia, 520 03
    • Research Site
  • Praha 4, Czechia, 140 59
    • Research Site
  • Usti nad Labem, Czechia, 401 13
    • Research Site
• France
  • Bayonne, France, 64100
    • Research Site
  • Besancon Cedex, France, 25030
    • Research Site
  • Bordeaux Cedex, France, 33076
    • Research Site
  • Bourg en Bresse, France, 01012
    • Research Site
  • Brest Cedex 2, France, 29609
    • Research Site
  • Caen, France, 14033
    • Research Site
  • Corbeil Essonnes Cedex, France, 91106
    • Research Site
  • Dijon, France, 21079
    • Research Site
  • Le Chesnay Cedex, France, 78157
    • Research Site
  • Lille, France, 59037
    • Research Site
  • Metz, France, 57085
    • Research Site
  • Montpellier Cedex 5, France, 34295
    • Research Site
  • NICE Cedex 01, France, 06001
    • Research Site
  • Nancy, France, 54035
    • Research Site
  • PARIS Cedex 12, France, 75571
    • Research Site
  • Paris, France, 75475
    • Research Site
  • Paris, France, 75019
    • Research Site
  • Paris Cedex 13, France, 75651
    • Research Site
  • Paris Cedex 18, France, 75877
    • Research Site
  • Rennes, France, 35033
    • Research Site
  • Rouen Cedex, France, 76031
    • Research Site
  • Saint Herblain, France, 44093
    • Research Site
  • Saint-Priez En Jarez, France, 42270
    • Research Site
  • Strasbourg Cedex, France, 67098
    • Research Site
  • Suresnes Cedex, France, 92151
    • Research Site
  • Toulouse Cedex 9, France, 31059
    • Research Site
• Germany
  • Altenburg, Germany, 04600
    • Research Site
  • Bad Neustadt, Germany, 97616
    • Research Site
  • Berlin, Germany, 12351
    • Research Site
  • Erlangen, Germany, 91054
    • Research Site
  • Essen, Germany, 45147
    • Research Site
  • Hamburg, Germany, 20099
    • Research Site
  • Hamburg, Germany, 22291
    • Research Site
  • Hamburg, Germany, 22043
    • Research Site
  • Hamburg, Germany, 22763
    • Research Site
  • Hannover, Germany, 30625
    • Research Site
  • Minden, Germany, 32429
    • Research Site
  • Münster, Germany, 48149
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Research Site
  • Kowloon, Hong Kong
    • Research Site
• Hungary
  • Baja, Hungary, 6500
    • Research Site
  • Balassagyarmat, Hungary, 2660
    • Research Site
  • Budapest, Hungary, 1083
    • Research Site
  • Budapest, Hungary, 1125
    • Research Site
  • Budapest, Hungary, 1134
    • Research Site
  • Budapest, Hungary, 1106
    • Research Site
  • Budapest, Hungary, 1204
    • Research Site
  • Debrecen, Hungary, 4043
    • Research Site
  • Győr, Hungary, 9000
    • Research Site
  • Kistarcsa, Hungary, 2143
    • Research Site
  • Miskolc, Hungary, 3526
    • Research Site
  • Nyíregyháza, Hungary, 4400
    • Research Site
  • Pécs, Hungary, 7623
    • Research Site
  • Sopron-Balf, Hungary, 9494
    • Research Site
  • Székesfehérvár, Hungary, 8000
    • Research Site
  • Tatabánya, Hungary, 2800
    • Research Site
• India
  • Bangalore, India, 560068
    • Research Site
  • Bangalore, India, 560002
    • Research Site
  • Bengaluru, India, 560076
    • Research Site
  • Dehradun, India, 248001
    • Research Site
  • Guntur, India, 522001
    • Research Site
  • Gurgaon, India, 122001
    • Research Site
  • Gurgaon, India, 122002
    • Research Site
  • Hyderabad, India, 500018
    • Research Site
  • Kanpur, India, 208002
    • Research Site
  • Kolkata, India, 700017
    • Research Site
  • Mangalore, India, 575002
    • Research Site
  • Nagpur, India, 420012
    • Research Site
  • Nagpur, India, 440012
    • Research Site
  • Nashik, India, 422005
    • Research Site
  • New Delhi, India, 110029
    • Research Site
  • New Delhi, India, 110005
    • Research Site
  • New Delhi, India, 110026
    • Research Site
  • Srikakulam, India, 532001
    • Research Site
  • Varanasi, India, 221004
    • Research Site
• Italy
  • Cona, Italy, 44124
    • Research Site
  • Genova, Italy, 16132
    • Research Site
  • Genova, Italy, 16128
    • Research Site
  • Massa, Italy, 55100
    • Research Site
  • Milano, Italy, 20132
    • Research Site
  • Modena, Italy, 41100
    • Research Site
  • Negrar, Italy, 37024
    • Research Site
  • Pavia, Italy, 27100
    • Research Site
  • Perugia, Italy, 06132
    • Research Site
  • Pietra Ligure, Italy, 17027
    • Research Site
  • Pisa, Italy, 56100
    • Research Site
  • Roma, Italy, 00152
    • Research Site
  • Roma, Italy, 00144
    • Research Site
  • Roma, Italy, 00161
    • Research Site
  • Siena, Italy, 53100
    • Research Site
  • Varese, Italy, 21100
    • Research Site
  • Verona, Italy, 37126
    • Research Site
  • Vicenza, Italy, 36100
    • Research Site
  • Vizzolo Predabissi, Italy, 20070
    • Research Site
• Korea, Republic of
  • Anyang-si, Korea, Republic of, 14068
    • Research Site
  • Busan, Korea, Republic of, 49241
    • Research Site
  • Busan, Korea, Republic of, 49201
    • Research Site
  • Cheongju-si, Korea, Republic of, 28644
    • Research Site
  • Daegu, Korea, Republic of, 42601
    • Research Site
  • Daegu, Korea, Republic of, 42415
    • Research Site
  • Daegu, Korea, Republic of, 700-721
    • Research Site
  • Daejeon-si, Korea, Republic of, 35233
    • Research Site
  • Goyang-si, Korea, Republic of, 411-706
    • Research Site
  • Gwangju, Korea, Republic of, 61469
    • Research Site
  • Incheon, Korea, Republic of, 400-711
    • Research Site
  • Jeju-do, Korea, Republic of, 63241
    • Research Site
  • Seongnam-si, Korea, Republic of, 13620
    • Research Site
  • Seoul, Korea, Republic of, 02447
    • Research Site
  • Seoul, Korea, Republic of, 04401
    • Research Site
  • Seoul, Korea, Republic of, 01830
    • Research Site
  • Seoul, Korea, Republic of, 02053
    • Research Site
• Mexico
  • Culiacan, Mexico, 80230
    • Research Site
  • D.F, Mexico, 14269
    • Research Site
  • Durango, Mexico, 34217
    • Research Site
  • Guadalajara, Mexico, 44280
    • Research Site
  • Mexico, Mexico, 01090
    • Research Site
  • Mexico City, Mexico, 6726
    • Research Site
  • Mexico City, Mexico, 07760
    • Research Site
  • Monterrey, Mexico, 64460
    • Research Site
  • México, Mexico, 03103
    • Research Site
  • Tijuana, Mexico, 22321
    • Research Site
• Peru
  • Bellavista, Peru, CALLAO 2
    • Research Site
  • Callao, Peru, CALLAO 02
    • Research Site
  • Lima, Peru, LIMA 01
    • Research Site
  • Lima, Peru, LIMA 1
    • Research Site
  • Lima, Peru, LIMA 31
    • Research Site
  • Lima, Peru, Lima-1
    • Research Site
  • Lima, Peru, LIMA 13
    • Research Site
  • Trujillo, Peru, 130101
    • Research Site
  • Urb. El Chipe, Peru, 20007
    • Research Site
• Poland
  • Białystok, Poland, 15-276
    • Research Site
  • Chełm, Poland, 22-100
    • Research Site
  • Działdowo, Poland, 13-200
    • Research Site
  • Gdańsk, Poland, 80-952
    • Research Site
  • Gdańsk, Poland, 80-803
    • Research Site
  • Grodzisk Mazowiecki, Poland, 05-825
    • Research Site
  • Gryfice, Poland, 72-300
    • Research Site
  • Katowice, Poland, 40-635
    • Research Site
  • Końskie, Poland, 26-200
    • Research Site
  • Kraków, Poland, 31-826
    • Research Site
  • Lublin, Poland, 20-954
    • Research Site
  • Olsztyn, Poland, 10-560
    • Research Site
  • Olsztyn, Poland, 10-082
    • Research Site
  • Ostrołęka, Poland, 07-410
    • Research Site
  • Rybnik, Poland, 44-200
    • Research Site
  • Sandomierz, Poland, 27-600
    • Research Site
  • Skarżysko-Kamienna, Poland, 26-110
    • Research Site
  • Warszawa, Poland, 02-957
    • Research Site
  • Warszawa, Poland, 03-242
    • Research Site
  • Zielona Góra, Poland, 65-046
    • Research Site
  • Łódź, Poland, 90-153
    • Research Site
  • Łódź, Poland, 93-113
    • Research Site
  • Świebodzin, Poland, 66-200
    • Research Site
• Romania
  • Bucharest, Romania, 050098
    • Research Site
  • Bucharest, Romania, 011461
    • Research Site
  • Bucharest, Romania, 020125
    • Research Site
  • Iasi, Romania, 700309
    • Research Site
  • Oradea, Romania, 410169
    • Research Site
  • Sibiu, Romania, 550166
    • Research Site
  • Timisoara, Romania, 300736
    • Research Site
  • Tirgu-Mures, Romania, 540136
    • Research Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454106
    • Research Site
  • Ekaterinburg, Russian Federation, 620102
    • Research Site
  • Izhevsk, Russian Federation, 426063
    • Research Site
  • Kazan, Russian Federation, 420012
    • Research Site
  • Kazan, Russian Federation, 420101
    • Research Site
  • Kemerovo, Russian Federation, 650002
    • Research Site
  • Moscow, Russian Federation, 117997
    • Research Site
  • Moscow, Russian Federation, 121374
    • Research Site
  • Moscow, Russian Federation, 115516
    • Research Site
  • Moscow, Russian Federation, 117292
    • Research Site
  • Moscow, Russian Federation, 123367
    • Research Site
  • Moscow, Russian Federation, 109004
    • Research Site
  • Nizhnii Novgorod, Russian Federation, 603018
    • Research Site
  • Nizhniy Novgorod, Russian Federation, 603005
    • Research Site
  • Novosibirsk, Russian Federation, 630051
    • Research Site
  • Novosibirsk, Russian Federation, 630003
    • Research Site
  • Ryazan, Russian Federation, 390039
    • Research Site
  • Saint Petersburg, Russian Federation, 196601
    • Research Site
  • Saint Petersburg, Russian Federation, 196247
    • Research Site
  • Saint-Petersburg, Russian Federation, 192242
    • Research Site
  • Saint-Petersburg, Russian Federation, 194354
    • Research Site
  • Samara, Russian Federation, 443095
    • Research Site
  • Samara, Russian Federation, 443096
    • Research Site
  • Saratov, Russian Federation, 410030
    • Research Site
  • Sochi, Russian Federation, 354057
    • Research Site
  • Tomsk, Russian Federation, 634063
    • Research Site
  • Ufa, Russian Federation, 450071
    • Research Site
  • Voronezh, Russian Federation, 394066
    • Research Site
  • Yaroslavl, Russian Federation, 150030
    • Research Site
• Saudi Arabia
  • Ar Riyāḑ, Saudi Arabia, 11426
    • Research Site
  • Jeddah, Saudi Arabia, 21423
    • Research Site
  • Riyadh, Saudi Arabia, 12372
    • Research Site
  • Riyadh, Saudi Arabia, 11525
    • Research Site
• Slovakia
  • Dolny Kubin, Slovakia, 02614
    • Research Site
  • Levoca, Slovakia, 054 01
    • Research Site
  • Liptovsky Mikulas, Slovakia, 031 23
    • Research Site
  • Martin, Slovakia, 03659
    • Research Site
  • Nitra, Slovakia, 949 01
    • Research Site
  • Rimavska Sobota, Slovakia, 97912
    • Research Site
  • Skalica, Slovakia, 909 82
    • Research Site
  • Spisska Nova Ves, Slovakia, 052 01
    • Research Site
  • Trencin, Slovakia, 81171
    • Research Site
  • Trnava, Slovakia, 91701
    • Research Site
  • Ziar nad Hronom, Slovakia, 96537
    • Research Site
• Spain
  • Albacete, Spain, 02006
    • Research Site
  • Alicante, Spain, 03010
    • Research Site
  • Badalona(Barcelona), Spain, 08916
    • Research Site
  • Barcelona, Spain, 08035
    • Research Site
  • Barcelona, Spain, 08003
    • Research Site
  • Barcelona, Spain, 08025
    • Research Site
  • Gerona, Spain, 17007
    • Research Site
  • Lleida, Spain, 25198
    • Research Site
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28006
    • Research Site
  • Sevilla, Spain, 41009
    • Research Site
  • Sevilla, Spain, 41013
    • Research Site
  • Valencia, Spain, 46009
    • Research Site
  • Valladolid, Spain, 47005
    • Research Site
  • Zaragoza, Spain, 50009
    • Research Site
• Sweden
  • Göteborg, Sweden, 413 45
    • Research Site
  • Linköping, Sweden, 581 85
    • Research Site
  • Lund, Sweden, 221 85
    • Research Site
  • Malmö, Sweden, 205 02
    • Research Site
  • Ostersund, Sweden, 831 83
    • Research Site
  • Skövde, Sweden, 541 85
    • Research Site
  • Solna, Sweden, 171 76
    • Research Site
  • Stockholm, Sweden, 118 83
    • Research Site
  • Stockholm, Sweden, 182 88
    • Research Site
  • Uppsala, Sweden, 751 85
    • Research Site
• Taiwan
  • Changhua, Taiwan, 500
    • Research Site
  • Kaohsiung, Taiwan, 80756
    • Research Site
  • Kaohsiung City, Taiwan, 83301
    • Research Site
  • Keelung, Taiwan, 20448
    • Research Site
  • New Taipei, Taiwan, 23561
    • Research Site
  • New Taipei City, Taiwan, 237
    • Research Site
  • Taichung, Taiwan, 40705
    • Research Site
  • Taichung, Taiwan, 40447
    • Research Site
  • Taichung City, Taiwan, 437
    • Research Site
  • Tainan, Taiwan, 704
    • Research Site
  • Tainan, Taiwan, 710
    • Research Site
  • Taipei, Taiwan, 10002
    • Research Site
  • Taipei, Taiwan, 10449
    • Research Site
  • Taipei, Taiwan, 11101
    • Research Site
  • Taipei, Taiwan, 116
    • Research Site
  • Taoyuan Hsien, Taiwan, 33305
    • Research Site
• Thailand
  • Bangkok, Thailand, 10300
    • Research Site
  • Bangkok, Thailand, 10330
    • Research Site
  • Bangkok, Thailand, 10400
    • Research Site
  • Bangkok, Thailand, 10700
    • Research Site
  • Bangkok, Thailand, 10600
    • Research Site
  • Bangkok, Thailand, 10220
    • Research Site
  • Chonburi, Thailand, 20000
    • Research Site
  • Hat Yai, Thailand, 90110
    • Research Site
  • Khlong Luang, Thailand, 12120
    • Research Site
  • Khon Kaen, Thailand, 40002
    • Research Site
  • Lampang, Thailand, 52000
    • Research Site
  • Muang, Thailand, 57000
    • Research Site
  • Nakhonpathom, Thailand, 73000
    • Research Site
  • Prachinburi, Thailand, 25000
    • Research Site
  • Rajthevi, Thailand, 10400
    • Research Site
  • Ratchaburi, Thailand, 70000
    • Research Site
  • Ubonratchathani, Thailand, 34000
    • Research Site
• Ukraine
  • Chernivtsі, Ukraine, 58001
    • Research Site
  • Ivano-Frankivsk, Ukraine, 76018
    • Research Site
  • Ivano-Frankivsk, Ukraine, 76008
    • Research Site
  • Kharkiv Region, Ukraine, 61176
    • Research Site
  • Kharkiv Region, Ukraine, 61018
    • Research Site
  • Kherson, Ukraine, 73000
    • Research Site
  • Kyiv, Ukraine, 03129
    • Research Site
  • Lutsk, Ukraine, 43024
    • Research Site
  • Lviv, Ukraine, 79013
    • Research Site
  • Poltava, Ukraine, 36038
    • Research Site
  • Ternopil, Ukraine, 46027
    • Research Site
  • Vinnytsia, Ukraine, 21005
    • Research Site
  • Zaporizhzhia, Ukraine, 69600
    • Research Site
  • Zaporizhzhia, Ukraine, 69068
    • Research Site
• Vietnam
  • Dong Nai, Vietnam, 81000
    • Research Site
  • Ha Noi, Vietnam, 10000
    • Research Site
  • Hanoi, Vietnam, 10000
    • Research Site
  • Ho Chi Minh, Vietnam, 70000
    • Research Site
  • Ho Chi Minh City, Vietnam, 70000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 130 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TICAGRELOR	Drug: Ticagrelor; Ticagrelor arm: Day 1, loading dose of ticagrelor followed by daily maintenance dose until Day 30.
PLACEBO_COMPARATOR: TICAGRELOR PLACEBO	Drug: Placebo; Placebo arm: Day 1, loading dose of placebo followed by placebo daily maintenance dose until Day 30.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Subsequent Stroke or Death	Participants with subsequent stroke or death	From randomisation (day 1) to visit 3 (day 30-34)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischaemic Stroke	Number of participants with ischaemic stroke	From randomisation (day 1) to visit 3 (day 30-34)
Number of Participants With Modified Rankin Scale (mRS) Score >1 at Visit 3	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.	Visit 3 (day 30-34)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Severe	Participants with bleeding event that fulfils serious adverse event criteria and is categorised as GUSTO Severe. GUSTO is a bleeding scale (GUSTO = Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries). GUSTO Severe bleeding is defined as any of the following: (1) fatal bleeding, (2) intracranial bleeding, or (3) bleeding that caused haemodynamic compromise requiring intervention	From randomisation (day 1) to visit 3 (day 30-34)
ICH or Fatal Bleeding Event	Participants with ICH or fatal bleeding event	From randomisation (day 1) to visit 3 (day 30-34)
Bleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Moderate/Severe	Participants with bleeding event that fulfils serious adverse event criteria and is categorised as GUSTO Moderate/Severe. GUSTO is a bleeding scale (GUSTO = Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries). GUSTO Severe bleeding is defined as any of the following: (1) fatal bleeding, (2) intracranial bleeding, or (3) bleeding that caused haemodynamic compromise requiring intervention. GUSTO Moderate bleeding is a bleeding requiring transfusion of whole blood or packed red blood cells without haemodynamic compromise	From randomisation (day 1) to visit 3 (day 30-34)
Premature Permanent Discontinuation of IP Due to Bleeding	Participants with premature permanent discontinuation of IP due to bleeding	From randomisation (day 1) to visit 3 (day 30-34)

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General 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.
• 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.

Helpful Links

• redacted SAP
• redacted CSP

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2018
• Primary Completion (ACTUAL): December 13, 2019
• Study Completion (ACTUAL): December 13, 2019

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 24, 2017
• First Posted (ACTUAL): November 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Acute ischaemic stroke; Transient Ischaemic Attack (TIA); Stroke
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemic Stroke; Ischemia; Ischemic Attack, Transient; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor
• Other Study ID Numbers: D5134C00003; 2016-004232-37 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No