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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03354429
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Acute Ischaemic Stroke Transient Ischaemic Attack Drug: Ticagrelor Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : December 16, 2019
Estimated Study Completion Date : December 16, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

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.




Primary Outcome Measures :
  1. Time from randomisation to first subsequent stroke or death [ Time Frame: Day1-Day30 ]
    To demonstrate superior efficacy of ticagrelor and ASA compared with placebo and ASA in AIS/TIA patients in the prevention of the composite of stroke and death at 30 days


Secondary Outcome Measures :
  1. Time from randomisation to first subsequent ischaemic stroke [ Time Frame: Day1-Day30 ]
    To demonstrate superior efficacy of ticagrelor and ASA compared with placebo and ASA in AIS/TIA patients in the prevention of ischaemic stroke at 30 days

  2. The modified Rankin Scale (mRS) score >1 at Visit 3 [ Time Frame: Day30 ]
    To demonstrate superior efficacy of ticagrelor and ASA compared with placebo and ASA in AIS/TIA patients in reducing overall disability at 30 days. 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.


Other Outcome Measures:
  1. Time from randomisation to first bleeding event that fulfils SAE criteria and is categorised as GUSTO Severe [ Time Frame: Day1-Day30 ]
    To assess the safety of ticagrelor and ASA compared with that of placebo and ASA in AIS/TIA patients, in particular with respect to major bleeding events

  2. Time from randomisation to first ICH or fatal bleeding event [ Time Frame: Day1-Day30 ]
    To assess the safety of ticagrelor and ASA compared with that of placebo and ASA in AIS/TIA patients, in particular with respect to major bleeding events

  3. Time from randomisation to first bleeding event that fulfils SAE criteria and is categorised as GUSTO Moderate/Severe [ Time Frame: Day1-Day30 ]
    To assess the safety of ticagrelor and ASA compared with that of placebo and ASA in AIS/TIA patients, in particular with respect to major bleeding events

  4. Time from randomisation to premature permanent discontinuation of IP due to bleeding [ Time Frame: Day1-Day30 ]
    To assess the safety of ticagrelor and ASA compared with that of placebo and ASA in AIS/TIA patients, in particular with respect to major bleeding events



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354429


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Locations
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Argentina
Research Site Recruiting
Adrogué, Argentina, 1846
Research Site Recruiting
Buenos Aires, Argentina, 1180AAX
Research Site Recruiting
Buenos Aires, Argentina, 1437
Research Site Recruiting
Buenos Aires, Argentina, AR-CP 1221
Research Site Withdrawn
Buenos Aires, Argentina, C1093AAS
Research Site Withdrawn
Buenos Aires, Argentina, C1431 CABA
Research Site Not yet recruiting
Buenos Aires, Argentina, C1437BZK
Research Site Recruiting
Buenos Aires, Argentina
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Capital Federal, Argentina
Research Site Not yet recruiting
Ciudad Autónoma de Bs. As., Argentina, C1199ABB
Research Site Recruiting
Cordoba, Argentina, 5000
Research Site Withdrawn
General Roca, Argentina, 8332
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Mar del Plata, Argentina, B7602CBM
Research Site Not yet recruiting
Mendoza, Argentina, M5500IDN
Research Site Withdrawn
Rosario, Argentina, 2000
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Rosario, Argentina, S2000DSV
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Rosario, Argentina, S200GAP
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Salta, Argentina
Australia
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Adelaide, Australia, 5000
Research Site Withdrawn
Adelaide, Australia, 5000
Research Site Withdrawn
Clayton, Australia, 3168
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Footscray, Australia, 3011
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Heidelberg, Australia, 3084
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Herston, Australia, 4029
Research Site Withdrawn
New Lambton Heights, Australia, 2305
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Parkville, Australia, 3050
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Southport, Australia, 4215
Belgium
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Antwerpen, Belgium, 2020
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Assebroek (Brugge), Belgium, 8310
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Bruges, Belgium, 8000
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Brussels, Belgium, 1200
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Dendermonde, Belgium, 9200
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Edegem, Belgium, 2650
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Kortrijk, Belgium, 8500
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Leuven, Belgium, 3000
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Liège, Belgium, 4000
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Oostende, Belgium, 8400
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Roeselare, Belgium, 8800
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Sint-Truiden, Belgium, 3800
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Yvoir, Belgium, 5530
Brazil
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Belo Horizonte, Brazil, 30140 062
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Botucatu, Brazil, 18618-687
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Curitiba, Brazil, 81210-310
Research Site Withdrawn
Florianópolis, Brazil, 88015-270
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Goiania, Brazil, 74083-100
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Joinville, Brazil, 89202-165
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Maringa, Brazil, 87015-000
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Porto Alegre, Brazil, 90035-074
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Porto Alegre, Brazil, 90610-000
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Ribeirao Preto, Brazil, 14015130
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Rio de Janeiro, Brazil, 22270-005
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Salvador, Brazil, 41820011
Research Site Suspended
Sao Paulo, Brazil, 04005-000
Bulgaria
Research Site Completed
Dupnitsa, Bulgaria, 2600
Research Site Completed
Kozloduy, Bulgaria, 3320
Research Site Completed
Lukovit, Bulgaria, 5770
Research Site Completed
Pazardzhik, Bulgaria, 4400
Research Site Completed
Pleven, Bulgaria, 5800
Research Site Completed
Sliven, Bulgaria, 8800
Research Site Completed
Sofia, Bulgaria, 1142
Research Site Completed
Sofia, Bulgaria, 1407
Research Site Completed
Sofia, Bulgaria, 1606
Research Site Withdrawn
Sofia, Bulgaria, 1606
Research Site Completed
Teteven, Bulgaria, 5700
Canada, Alberta
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Calgary, Alberta, Canada, T2N 2T9
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Edmonton, Alberta, Canada, T6G 2B7
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Edmonton, Alberta, Canada, T6L 5X8
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Lethbridge, Alberta, Canada, T1J 0N9
Canada, British Columbia
Research Site Withdrawn
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Quebec
Research Site Withdrawn
Greenfield Park, Quebec, Canada, J4V 2H1
Research Site Withdrawn
Montreal, Quebec, Canada, H3G 1A4
Canada
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Chicoutimi, Canada, G7H 5H6
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Quebec, Canada, G1J 1Z4
China
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Baoji, China, 721008
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Baotou, China, 014016
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Beijing, China, 100070
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Beijing, China, 100191
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Beijing, China, 101199
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Beijing, China
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Changchun, China, 130041
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Changsha, China, 410004
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Changsha, China, 410013
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Changsha, China, 410078
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Changsha, China, 430033
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Chifeng, China, 024000
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Dalian, China, 116001
Research Site Withdrawn
Dalian, China, 116033
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Daqing, China, 163000
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Foshan, China, 528000
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Guangzhou, China, 510080
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Guangzhou, China, 510180
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Guangzhou, China, 510630
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Guiyang, China, 550004
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Haikou, China, 570311
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Hangzhou, China, 310009
Research Site Completed
Harbin, China, 150000
Research Site Withdrawn
Hengshui, China
Research Site Recruiting
Hohhot, China, 010017
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Hohhot, China, 10050
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Jilin, China
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Jinan, China, 250001
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Jinzhou, China, 121004
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Linhai, China, 318000
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Liuzhou, China
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Nanchang, China, 330006
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Nanjing, China, 210002
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Nanjing, China, 210011
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Nanjing, China, 210029
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Nantong, China, 226001
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Ningbo, China, 315010
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Qiqihar, China
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Shanghai, China, 200040
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Shanghai, China, 200080
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Shanghai, China, 200090
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Shanghai, China, CN-200120
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Shenyang, China, 110016
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Taiyuan, China, 030001
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Taiyuan, China
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Tangshan, China, 063001
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Tangshan, China
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Tianjin, China, 300052
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Tianjin, China, 300060
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Tianjin, China, 300121
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Wenzhou, China, 325000
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Wu Han, China, 430060
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Wuhan, China, 430022
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Wuhan, China, 430033
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Wuhan, China, CN-430030
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Wuxi, China, 214002
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Xi'an, China, 710038
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Xi'an, China, 710061
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Xiamen, China, 361004
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Xining, China, 810001
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Xuzhou, China, 221006
Czechia
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Brno, Czechia, 656 91
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Chomutov, Czechia, 430 12
Research Site Withdrawn
Olomouc, Czechia, 775 20
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Ostrava, Czechia, 703 84
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Ostrava, Czechia, 708 52
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Pardubice, Czechia, 520 03
Research Site Withdrawn
Praha 2, Czechia, 120 00
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Praha 4, Czechia, 140 59
Research Site Withdrawn
Praha, Czechia, 169 02
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Usti nad Labem, Czechia, 401 13
France
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Bayonne, France, 64100
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Besancon Cedex, France, 25030
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Bordeaux Cedex, France, 33076
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Bourg en Bresse, France, 01012
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Brest Cedex 2, France, 29609
Research Site Withdrawn
Bron, France, 69500
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Caen, France, 14033
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Corbeil Essonnes Cedex, France, 91106
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Dijon, France, 21079
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Le Chesnay Cedex, France, 78157
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Lille, France, 59037
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Metz, France, 57085
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Montpellier Cedex 5, France, 34295
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Nancy, France, 54035
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NICE Cedex 01, France, 06001
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PARIS Cedex 12, France, 75571
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Paris Cedex 13, France, 75651
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Paris Cedex 18, France, 75877
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Paris, France, 75019
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Pringy Cedex, France, 74374
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Rennes, France, 35033
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Rouen Cedex, France, 76031
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Saint Herblain, France, 44093
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Saint-Priez En Jarez, France, 42270
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Strasbourg Cedex, France, 67098
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Suresnes Cedex, France, 92151
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Toulouse Cedex 9, France, 31059
Germany
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Altenburg, Germany, 04600
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Bad Neustadt, Germany, 97616
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Berlin, Germany, 12351
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Erlangen, Germany, 91054
Research Site Recruiting
Essen, Germany, 45147
Research Site Completed
Hamburg, Germany, 20099
Research Site Recruiting
Hamburg, Germany, 22043
Research Site Recruiting
Hamburg, Germany, 22291
Research Site Recruiting
Hamburg, Germany, 22763
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Hannover, Germany, 30625
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Minden, Germany, 32429
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Münster, Germany, 48149
Hong Kong
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Hong Kong, Hong Kong
Research Site Withdrawn
Hong Kong, Hong Kong
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HongKong, Hong Kong
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Kowloon, Hong Kong
Hungary
Research Site Recruiting
Baja, Hungary, 6500
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Balassagyarmat, Hungary, 2660
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Budapest, Hungary, 1083
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Budapest, Hungary, 1106
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Budapest, Hungary, 1125
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Budapest, Hungary, 1134
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Budapest, Hungary, 1204
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Debrecen, Hungary, 4043
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Győr, Hungary, 9000
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Kistarcsa, Hungary, 2143
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Miskolc, Hungary, 3526
Research Site Withdrawn
Nagykanizsa, Hungary, 8800
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Nyíregyháza, Hungary, 4400
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Pécs, Hungary, 7623
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Sopron-Balf, Hungary, 9494
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Székesfehérvár, Hungary, 8000
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Tatabánya, Hungary, 2800
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Zalaegerszeg, Hungary, 8900
India
Research Site Recruiting
Bangalore, India, 560002
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Bangalore, India, 560068
Research Site Withdrawn
Chennai, India, 600001
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Guntur, India, 522001
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Gurgaon, India, 122001
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Hyderabad, India, 500018
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Kanpur, India, 208002
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Kolkata, India, 700017
Research Site Withdrawn
Kolkatta, India, 700027
Research Site Withdrawn
Ludhiana, India, 141 008
Research Site Recruiting
Madurai, India, 625107
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Mangalore, India, 575002
Research Site Withdrawn
Mangalore, India, 575003
Research Site Withdrawn
Mumbai, India, 400008
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Nagpur, India, 420012
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Nagpur, India, 440012
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Nashik, India, 422005
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New Delhi, India, 110005
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New Delhi, India, 110026
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New Delhi, India, 110029
Research Site Withdrawn
New Delhi, India, 110060
Research Site Withdrawn
Patna, India, 800014
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Srikakulam, India, 532001
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Trivandrum, India, 695123
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Varanasi, India, 221004
Research Site Withdrawn
Vijayawada, India, 520002
Research Site Withdrawn
Vijayawada, India, 520008
Italy
Research Site Recruiting
Ferrara, Italy, 44124
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Genova, Italy, 16128
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Genova, Italy, 16132
Research Site Withdrawn
Lecce, Italy, 73100
Research Site Withdrawn
Lecco, Italy, 23900
Research Site Withdrawn
Mantova, Italy, 46100
Research Site Recruiting
Massa, Italy, 55100
Research Site Recruiting
Milano, Italy, 20132
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Modena, Italy, 41100
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Negrar, Italy, 37024
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Pavia, Italy, 27100
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Perugia, Italy, 06132
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Pietra Ligure, Italy, 17027
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Pisa, Italy, 56100
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Roma, Italy, 00144
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Roma, Italy, 00152
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Siena, Italy, 53100
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Vicenza, Italy, 36100
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Vizzolo Predabissi, Italy, 20070
Korea, Republic of
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Anyang-si, Korea, Republic of, 14068
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Busan, Korea, Republic of, 49201
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Busan, Korea, Republic of, 49241
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Cheongju-si, Korea, Republic of, 28644
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Daegu, Korea, Republic of, 42415
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Daegu, Korea, Republic of, 42601
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Daegu, Korea, Republic of, 700-721
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Daejeon-si, Korea, Republic of, 35233
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Goyang-si, Korea, Republic of, 411-706
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Gwangju, Korea, Republic of, 61469
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Incheon, Korea, Republic of, 400-711
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Jeju-do, Korea, Republic of, 63241
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Seongnam-si, Korea, Republic of, 13620
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Seoul, Korea, Republic of, 01830
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Seoul, Korea, Republic of, 02053
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Seoul, Korea, Republic of, 02447
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Seoul, Korea, Republic of, 04401
Mexico
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Culiacan, Mexico, 80230
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D.F, Mexico, 14269
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Durango, Mexico, 34217
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Guadalajara, Mexico, 44280
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Mexico City, Mexico, 07760
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Mexico City, Mexico, 6726
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Mexico, Mexico, 01090
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Monterrey, Mexico, 64460
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México, Mexico, 03103
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Tijuana, Mexico, 22321
Peru
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Bellavista, Peru, CALLAO 2
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Callao, Peru, CALLAO 02
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Lima, Peru, LIMA 01
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Lima, Peru, LIMA 13
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Lima, Peru, LIMA 1
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Lima, Peru, LIMA 31
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Lima, Peru, Lima-1
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Trujillo, Peru, 130101
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Urb. El Chipe, Peru
Poland
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Białystok, Poland, 15-276
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Chełm, Poland, 22-100
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Działdowo, Poland, 13-200
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Gdańsk, Poland, 80-803
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Gdańsk, Poland, 80-952
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Grodzisk Mazowiecki, Poland, 05-825
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Gryfice, Poland, 72-300
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Katowice, Poland, 40-635
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Końskie, Poland, 26-200
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Kraków, Poland, 31-826
Research Site Withdrawn
Lublin, Poland, 20-718
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Lublin, Poland, 20-954
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Olsztyn, Poland, 10-082
Research Site Recruiting
Olsztyn, Poland, 10-560
Research Site Recruiting
Ostrołęka, Poland, 07-410
Research Site Recruiting
Rybnik, Poland, 44-200
Research Site Recruiting
Sandomierz, Poland, 27-600
Research Site Recruiting
Skarżysko-Kamienna, Poland, 26-110
Research Site Withdrawn
Staszów, Poland, 28-200
Research Site Recruiting
Warszawa, Poland, 02-957
Research Site Withdrawn
Warszawa, Poland, 02-957
Research Site Withdrawn
Zabrze, Poland, 41-800
Research Site Recruiting
Zielona Góra, Poland, 65-046
Research Site Recruiting
Łódź, Poland, 90-153
Research Site Recruiting
Łódź, Poland, 93-113
Research Site Recruiting
Świebodzin, Poland
Romania
Research Site Recruiting
Bucharest, Romania, 011461
Research Site Recruiting
Bucharest, Romania, 020125
Research Site Recruiting
Bucharest, Romania, 050098
Research Site Suspended
Bucuresti, Romania, 022328
Research Site Recruiting
Iasi, Romania, 700309
Research Site Recruiting
Oradea, Romania, 410169
Research Site Recruiting
Sibiu, Romania, 550166
Research Site Suspended
Suceava, Romania, 720284
Research Site Suspended
Timisoara, Romania, 300723
Research Site Recruiting
Timisoara, Romania, 300736
Research Site Recruiting
Tirgu-Mures, Romania, 540136
Russian Federation
Research Site Recruiting
Chelyabinsk, Russian Federation, 454106
Research Site Withdrawn
Ekaterinburg, Russian Federation, 620039
Research Site Recruiting
Ekaterinburg, Russian Federation, 620102
Research Site Recruiting
Izhevsk, Russian Federation, 426063
Research Site Withdrawn
Kazan, Russian Federation, 420012
Research Site Recruiting
Kazan, Russian Federation, 420012
Research Site Recruiting
Kazan, Russian Federation, 420101
Research Site Not yet recruiting
Kemerovo, Russian Federation, 650002
Research Site Recruiting
Kemerovo, Russian Federation, 650002
Research Site Not yet recruiting
Krasnoyarsk, Russian Federation, 660022
Research Site Recruiting
Moscow, Russian Federation, 109004
Research Site Withdrawn
Moscow, Russian Federation, 111123
Research Site Recruiting
Moscow, Russian Federation, 115516
Research Site Recruiting
Moscow, Russian Federation, 117292
Research Site Recruiting
Moscow, Russian Federation, 117997
Research Site Withdrawn
Moscow, Russian Federation, 119049
Research Site Not yet recruiting
Moscow, Russian Federation, 121374
Research Site Recruiting
Moscow, Russian Federation, 121374
Research Site Recruiting
Moscow, Russian Federation, 123367
Research Site Recruiting
Nizhnii Novgorod, Russian Federation, 603018
Research Site Recruiting
Nizhniy Novgorod, Russian Federation, 603005
Research Site Recruiting
Novosibirsk, Russian Federation, 630003
Research Site Completed
Novosibirsk, Russian Federation, 630051
Research Site Withdrawn
Perm, Russian Federation, 614068
Research Site Withdrawn
Ryazan, Russian Federation, 390027
Research Site Recruiting
Ryazan, Russian Federation, 390039
Research Site Recruiting
Saint Petersburg, Russian Federation, 196247
Research Site Recruiting
Saint Petersburg, Russian Federation, 196601
Research Site Recruiting
Saint-Petersburg, Russian Federation, 192242
Research Site Recruiting
Saint-Petersburg, Russian Federation, 194354
Research Site Recruiting
Samara, Russian Federation, 443095
Research Site Recruiting
Samara, Russian Federation, 443096
Research Site Recruiting
Saratov, Russian Federation, 410030
Research Site Recruiting
Sochi, Russian Federation, 354057
Research Site Not yet recruiting
Tomsk, Russian Federation, 634063
Research Site Recruiting
Tomsk, Russian Federation, 634063
Research Site Recruiting
Ufa, Russian Federation, 450071
Research Site Recruiting
Voronezh, Russian Federation, 394066
Research Site Recruiting
Yaroslavl, Russian Federation, 150030
Saudi Arabia
Research Site Recruiting
Ar Riyāḑ, Saudi Arabia, 11426
Research Site Recruiting
Jeddah, Saudi Arabia
Research Site Recruiting
Riyadh, Saudi Arabia, 11525
Research Site Recruiting
Riyadh, Saudi Arabia, 12372
Research Site Withdrawn
Riyadh, Saudi Arabia, 12746
Slovakia
Research Site Withdrawn
Bojnice, Slovakia, 972 01
Research Site Recruiting
Dolny Kubin, Slovakia
Research Site Recruiting
Galanta, Slovakia, 92422
Research Site Withdrawn
Komarno, Slovakia, 94501
Research Site Recruiting
Levoca, Slovakia, 054 01
Research Site Recruiting
Liptovsky Mikulas, Slovakia, 031 23
Research Site Recruiting
Martin, Slovakia, 03659
Research Site Recruiting
Nitra, Slovakia, 949 01
Research Site Recruiting
Rimavska Sobota, Slovakia, 97912
Research Site Recruiting
Skalica, Slovakia, 909 82
Research Site Recruiting
Spisska Nova Ves, Slovakia, 052 01
Research Site Recruiting
Trencin, Slovakia, 81171
Research Site Recruiting
Trnava, Slovakia, 91701
Research Site Recruiting
Ziar nad Hronom, Slovakia
Spain
Research Site Recruiting
Albacete, Spain, 02006
Research Site Recruiting
Alicante, Spain, 03010
Research Site Recruiting
Badalona(Barcelona), Spain, 08916
Research Site Recruiting
Barcelona, Spain, 08003
Research Site Recruiting
Barcelona, Spain, 08025
Research Site Recruiting
Barcelona, Spain, 08035
Research Site Recruiting
Gerona, Spain, 17007
Research Site Recruiting
Lleida, Spain, 25198
Research Site Recruiting
Madrid, Spain, 28006
Research Site Recruiting
Madrid, Spain, 28034
Research Site Recruiting
Sevilla, Spain, 41009
Research Site Recruiting
Sevilla, Spain, 41013
Research Site Recruiting
Valencia, Spain, 46009
Research Site Recruiting
Valladolid, Spain, 47005
Research Site Recruiting
Zaragoza, Spain, 50009
Sweden
Research Site Not yet recruiting
Gävle, Sweden, 801 88
Research Site Recruiting
Göteborg, Sweden, 413 45
Research Site Recruiting
Linköping, Sweden, 581 85
Research Site Recruiting
Lund, Sweden, 221 85
Research Site Not yet recruiting
Malmö, Sweden, 205 02
Research Site Withdrawn
Mora, Sweden, 792 85
Research Site Recruiting
Ostersund, Sweden, 831 83
Research Site Withdrawn
Skellefteå, Sweden, 931 41
Research Site Recruiting
Skövde, Sweden, 541 85
Research Site Recruiting
Solna, Sweden, 171 76
Research Site Recruiting
Stockholm, Sweden, 118 83
Research Site Recruiting
Stockholm, Sweden, 182 88
Research Site Recruiting
Uppsala, Sweden, 751 85
Taiwan
Research Site Recruiting
Changhua, Taiwan, 500
Research Site Recruiting
Kaohsiung City, Taiwan, 83301
Research Site Recruiting
Kaohsiung, Taiwan, 80756
Research Site Recruiting
Keelung, Taiwan
Research Site Recruiting
New Taipei City, Taiwan, 237
Research Site Recruiting
New Taipei, Taiwan
Research Site Recruiting
Taichung City, Taiwan, 437
Research Site Recruiting
Taichung, Taiwan, 40705
Research Site Recruiting
Taichung, Taiwan
Research Site Recruiting
Tainan, Taiwan, 704
Research Site Recruiting
Tainan, Taiwan, 710
Research Site Withdrawn
Taipei City, Taiwan, 11217
Research Site Active, not recruiting
Taipei, Taiwan, 10002
Research Site Recruiting
Taipei, Taiwan, 10449
Research Site Recruiting
Taipei, Taiwan, 11101
Research Site Recruiting
Taoyuan Hsien, Taiwan
Thailand
Research Site Recruiting
Bangkok, Thailand, 10220
Research Site Recruiting
Bangkok, Thailand, 10300
Research Site Recruiting
Bangkok, Thailand, 10330
Research Site Recruiting
Bangkok, Thailand, 10400
Research Site Recruiting
Bangkok, Thailand, 10600
Research Site Recruiting
Bangkok, Thailand, 10700
Research Site Recruiting
Chonburi, Thailand, 20000
Research Site Recruiting
Hat Yai, Thailand, 90110
Research Site Recruiting
Khlong Luang, Thailand, 12120
Research Site Recruiting
Khon Kaen, Thailand, 40002
Research Site Recruiting
Lampang, Thailand, 52000
Research Site Recruiting
Muang, Thailand, 57000
Research Site Recruiting
Nakhonpathom, Thailand, 73000
Research Site Recruiting
Prachinburi, Thailand, 25000
Research Site Recruiting
Rajthevi, Thailand, 10400
Research Site Recruiting
Ratchaburi, Thailand, 70000
Research Site Recruiting
Ubonratchathani, Thailand, 34000
Ukraine
Research Site Recruiting
Chernivtsi, Ukraine
Research Site Withdrawn
Dnepropetrovsk, Ukraine, 49006
Research Site Withdrawn
Dnipropetrovsk, Ukraine, 49070
Research Site Withdrawn
Dnipro, Ukraine
Research Site Recruiting
Ivano-Frankivsk, Ukraine, 76008
Research Site Recruiting
Ivano-Frankivsk, Ukraine
Research Site Recruiting
Kharkiv, Ukraine, 61018
Research Site Withdrawn
Kharkiv, Ukraine, 61058
Research Site Withdrawn
Kharkiv, Ukraine, 61068
Research Site Recruiting
Kharkiv, Ukraine, 61176
Research Site Recruiting
Kherson, Ukraine, 73000
Research Site Withdrawn
Kyiv, Ukraine, 03110
Research Site Recruiting
Kyiv, Ukraine, 03129
Research Site Recruiting
Lutsk, Ukraine, 43024
Research Site Recruiting
Lviv, Ukraine, 79013
Research Site Recruiting
Poltava, Ukraine
Research Site Recruiting
Ternopil, Ukraine, 46027
Research Site Recruiting
Vinnytsia, Ukraine, 21005
Research Site Withdrawn
Zaporizhzhya, Ukraine, 69035
Research Site Recruiting
Zaporizhzhya, Ukraine, 69068
Research Site Recruiting
Zaporizhzhya, Ukraine, 69600
Vietnam
Research Site Recruiting
Da Nang, Vietnam, 550000
Research Site Recruiting
Dong Nai, Vietnam, 810000
Research Site Recruiting
Ha Noi, Vietnam, 100000
Research Site Recruiting
Hanoi, Vietnam, 100000
Research Site Recruiting
Ho Chi Minh City, Vietnam, 700000
Research Site Recruiting
Ho Chi Minh, Vietnam, 700000
Sponsors and Collaborators
AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03354429     History of Changes
Other Study ID Numbers: D5134C00003
2016-004232-37 ( EudraCT Number )
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

Layout table for additional information
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

Keywords provided by AstraZeneca:
Acute ischaemic stroke; Transient Ischaemic Attack (TIA); Stroke

Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebral Infarction
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs