NCT03354429

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
11,016

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2018

Geographic Reach
28 countries

387 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 22, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

1.9 years

First QC Date

November 20, 2017

Results QC Date

November 18, 2020

Last Update Submit

December 21, 2020

Conditions

Keywords

Acute ischaemic stroke; Transient Ischaemic Attack (TIA); Stroke

Outcome Measures

Primary Outcomes (1)

  • Composite of Subsequent Stroke or Death

    Participants with subsequent stroke or death

    From randomisation (day 1) to visit 3 (day 30-34)

Secondary Outcomes (2)

  • 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

    Visit 3 (day 30-34)

Other Outcomes (4)

  • Bleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Severe

    From randomisation (day 1) to visit 3 (day 30-34)

  • 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

    From randomisation (day 1) to visit 3 (day 30-34)

  • +1 more other outcomes

Study Arms (2)

TICAGRELOR

EXPERIMENTAL
Drug: Ticagrelor

TICAGRELOR PLACEBO

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Ticagrelor arm: Day 1, loading dose of ticagrelor followed by daily maintenance dose until Day 30.

TICAGRELOR

Placebo arm: Day 1, loading dose of placebo followed by placebo daily maintenance dose until Day 30.

TICAGRELOR PLACEBO

Eligibility Criteria

Age40 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed informed consent prior to any study-specific procedure
  • ≥40 years of age
  • Acute onset of cerebral ischaemia due to
  • 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
  • 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
  • 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
  • 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

You may not qualify if:

  • Need for or an anticipated need for any of the following:
  • Dual antiplatelet therapy with ASA and P2Y12 inhibitors (including patients with carotid artery stenting and percutaneous coronary intervention)
  • 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
  • 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
  • Any history of atrial fibrillation/flutter, ventricular aneurysm, or suspicion of other cardioembolic pathology for TIA or stroke
  • Patients who should receive or have received any intravenous or intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation
  • 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
  • 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
  • Inability of the patient to understand and/or comply with study procedures and/or follow-up, in the opinion of the Investigator
  • Known hypersensitivity to ticagrelor or ASA
  • Need for or an anticipated need for oral or intravenous therapy with any of the following:
  • 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
  • Long-term (\>7 days) non-steroidal anti-inflammatory drugs
  • Known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura)
  • Known severe liver disease (eg, ascites or signs of coagulopathy)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (387)

Research Site

Adrogué, 1846, Argentina

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Buenos Aires, 1180AAX, Argentina

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Buenos Aires, 1437, Argentina

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Buenos Aires, AR-CP 1221, Argentina

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Buenos Aires, C1425 FSD, Argentina

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Buenos Aires, C1437BZK, Argentina

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Capital Federal, 1428, Argentina

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Ciudad Autónoma de Bs. As., C1199ABB, Argentina

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Córdoba, 5000, Argentina

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Mar del Plata, B7602CBM, Argentina

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Mendoza, M5500IDN, Argentina

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Rosario, S2000DSV, Argentina

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Rosario, S200GAP, Argentina

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Salta, A4400, Argentina

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Adelaide, 5000, Australia

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Heidelberg, 3084, Australia

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Herston, 4029, Australia

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Parkville, 3050, Australia

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Southport, 4215, Australia

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St Albans, 3021, Australia

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Antwerp, 2020, Belgium

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Assebroek (Brugge), 8310, Belgium

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Bruges, 8000, Belgium

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Brussels, 1200, Belgium

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Dendermonde, 9200, Belgium

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Edegem, 2650, Belgium

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Kortrijk, 8500, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Ostend, 8400, Belgium

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Roeselare, 8800, Belgium

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Sint-Truiden, 3800, Belgium

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Yvoir, 5530, Belgium

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Botucatu, 18618-687, Brazil

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Curitiba, 81210-310, Brazil

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Goiânia, 74083-100, Brazil

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Joinville, 89202-165, Brazil

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Maringá, 87015-000, Brazil

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Porto Alegre, 90610-000, Brazil

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Ribeirão Preto, 14015130, Brazil

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Rio de Janeiro, 22270-005, Brazil

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Salvador, 41820011, Brazil

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Dupnitsa, 2600, Bulgaria

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Kozloduy, 3320, Bulgaria

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Lukovit, 5770, Bulgaria

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Pazardzhik, 4400, Bulgaria

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Pleven, 5800, Bulgaria

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Sliven, 8800, Bulgaria

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Sofia, 1142, Bulgaria

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Sofia, 1407, Bulgaria

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Sofia, 1606, Bulgaria

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Teteven, 5700, Bulgaria

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Calgary, Alberta, T2N 2T9, Canada

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Edmonton, Alberta, T6G 2B7, Canada

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Lethbridge, Alberta, T1J 0N9, Canada

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Chicoutimi, G7H 5H6, Canada

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Baoji, 721008, China

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Baotou, 014016, China

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Beijing, 100049, China

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Beijing, 100070, China

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Beijing, 100191, China

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Changsha, 410013, China

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Changsha, 410078, China

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Changsha, 430033, China

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Chifeng, 024000, China

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Daqing, 163000, China

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Foshan, 528000, China

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Guangzhou, 510080, China

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Guangzhou, 510180, China

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Guangzhou, 510630, China

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Guiyang, 550004, China

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Haikou, 570311, China

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Hangzhou, 310009, China

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Hohhot, 010017, China

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Hohhot, 10050, China

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Jinan, 250001, China

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Jinzhou, 121004, China

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Liuchow, 545006, China

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Nanchang, 330006, China

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Nanjing, 210029, China

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Nantong, 226001, China

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Ningbo, 315010, China

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Shanghai, 200080, China

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Shanghai, 200090, China

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Shanghai, CN-200120, China

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Shenyang, 110016, China

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Taiyuan, 030001, China

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Tangshan, 063001, China

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Tianjin, 300060, China

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Tianjin, 300121, China

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Wenzhou, 325000, China

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Wuhan, 430022, China

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Wuhan, 430033, China

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Wuhan, 430060, China

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Wuxi, 214002, China

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Xi'an, 710061, China

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Xiamen, 361004, China

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Xining, 810001, China

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Xuzhou, 221006, China

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Brno, 656 91, Czechia

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Chomutov, 430 12, Czechia

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Ostrava, 703 84, Czechia

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Ostrava, 708 52, Czechia

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Pardubice, 520 03, Czechia

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Prague, 140 59, Czechia

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Ústí nad Labem, 401 13, Czechia

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Bayonne, 64100, France

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Besançon, 25030, France

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Bordeaux, 33076, France

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Bourg-en-Bresse, 01012, France

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Brest, 29609, France

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Caen, 14033, France

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Corbeil-Essonnes, 91106, France

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Dijon, 21079, France

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Le Chesnay, 78157, France

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Lille, 59037, France

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Metz, 57085, France

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Montpellier, 34295, France

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Nancy, 54035, France

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Nice, 06001, France

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Paris, 75019, France

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Paris, 75475, France

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Paris, 75571, France

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Paris, 75651, France

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Paris, 75877, France

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Rennes, 35033, France

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Rouen, 76031, France

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Saint-Herblain, 44093, France

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Saint-Priez En Jarez, 42270, France

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Strasbourg, 67098, France

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Suresnes, 92151, France

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Toulouse, 31059, France

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Altenburg, 04600, Germany

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Bad Neustadt an der Saale, 97616, Germany

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Berlin, 12351, Germany

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Erlangen, 91054, Germany

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Essen, 45147, Germany

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Hamburg, 20099, Germany

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Hamburg, 22043, Germany

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Hamburg, 22291, Germany

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Hamburg, 22763, Germany

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Hanover, 30625, Germany

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Minden, 32429, Germany

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Münster, 48149, Germany

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Hong Kong, Hong Kong

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Kowloon, Hong Kong

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Baja, 6500, Hungary

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Balassagyarmat, 2660, Hungary

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Budapest, 1083, Hungary

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Budapest, 1106, Hungary

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Budapest, 1125, Hungary

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Budapest, 1134, Hungary

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Budapest, 1204, Hungary

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Debrecen, 4043, Hungary

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Győr, 9000, Hungary

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Kistarcsa, 2143, Hungary

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Miskolc, 3526, Hungary

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Nyíregyháza, 4400, Hungary

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Pécs, 7623, Hungary

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Sopron-Balf, 9494, Hungary

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Székesfehérvár, 8000, Hungary

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Tatabánya, 2800, Hungary

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Bangalore, 560002, India

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Bangalore, 560068, India

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Bengaluru, 560076, India

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Dehradun, 248001, India

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Guntur, 522001, India

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Gūrgaon, 122001, India

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Gūrgaon, 122002, India

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Hyderabad, 500018, India

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Kanpur, 208002, India

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Kolkata, 700017, India

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Mangalore, 575002, India

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Nagpur, 420012, India

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Nagpur, 440012, India

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Nashik, 422005, India

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New Delhi, 110005, India

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New Delhi, 110026, India

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New Delhi, 110029, India

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Srikakulam, 532001, India

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Varanasi, 221004, India

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Cona, 44124, Italy

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Genova, 16128, Italy

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Genova, 16132, Italy

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Massa, 55100, Italy

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Milan, 20132, Italy

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Modena, 41100, Italy

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Negrar, 37024, Italy

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Pavia, 27100, Italy

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Perugia, 06132, Italy

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Pietra Ligure, 17027, Italy

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Pisa, 56100, Italy

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Roma, 00144, Italy

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Roma, 00152, Italy

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Roma, 00161, Italy

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Siena, 53100, Italy

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Varese, 21100, Italy

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Verona, 37126, Italy

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Vicenza, 36100, Italy

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Vizzolo Predabissi, 20070, Italy

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Culiacán, 80230, Mexico

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D.F, 14269, Mexico

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Durango, 34217, Mexico

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Guadalajara, 44280, Mexico

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Mexico City, 07760, Mexico

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Mexico City, 6726, Mexico

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México, 01090, Mexico

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México, 03103, Mexico

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Monterrey, 64460, Mexico

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Tijuana, 22321, Mexico

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Bellavista, CALLAO 2, Peru

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Callao, CALLAO 02, Peru

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Lima, LIMA 01, Peru

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Lima, LIMA 13, Peru

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Lima, LIMA 1, Peru

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Lima, LIMA 31, Peru

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Lima, Lima-1, Peru

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Trujillo, 130101, Peru

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Urb. El Chipe, 20007, Peru

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Bialystok, 15-276, Poland

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Chełm, 22-100, Poland

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Działdowo, 13-200, Poland

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Gdansk, 80-803, Poland

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Gdansk, 80-952, Poland

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Gmina Końskie, 26-200, Poland

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Gmina Świebodzin, 66-200, Poland

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Grodzisk Mazowiecki, 05-825, Poland

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Gryfice, 72-300, Poland

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Katowice, 40-635, Poland

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Krakow, 31-826, Poland

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Lodz, 90-153, Poland

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Lodz, 93-113, Poland

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Lublin, 20-954, Poland

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Olsztyn, 10-082, Poland

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Olsztyn, 10-560, Poland

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Ostrołęka, 07-410, Poland

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Rybnik, 44-200, Poland

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Sandomierz, 27-600, Poland

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Skarżysko-Kamienna, 26-110, Poland

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Warsaw, 02-957, Poland

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Warsaw, 03-242, Poland

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Zielona Góra, 65-046, Poland

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Bucharest, 011461, Romania

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Bucharest, 020125, Romania

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Bucharest, 050098, Romania

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Iași, 700309, Romania

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Oradea, 410169, Romania

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Sibiu, 550166, Romania

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Târgu Mureş, 540136, Romania

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Timișoara, 300736, Romania

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Chelyabinsk, 454106, Russia

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Izhevsk, 426063, Russia

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Kazan', 420012, Russia

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Kazan', 420101, Russia

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Kemerovo, 650002, Russia

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Moscow, 109004, Russia

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Moscow, 115516, Russia

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Moscow, 117292, Russia

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Moscow, 117997, Russia

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Moscow, 121374, Russia

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Moscow, 123367, Russia

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Nizhny Novgorod, 603005, Russia

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Nizhny Novgorod, 603018, Russia

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Novosibirsk, 630003, Russia

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Novosibirsk, 630051, Russia

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Ryazan, 390039, Russia

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Saint Petersburg, 192242, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 196247, Russia

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Saint Petersburg, 196601, Russia

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Samara, 443095, Russia

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Samara, 443096, Russia

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Saratov, 410030, Russia

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Sochi, 354057, Russia

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Tomsk, 634063, Russia

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Ufa, 450071, Russia

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Voronezh, 394066, Russia

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Yaroslavl, 150030, Russia

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Yekaterinburg, 620102, Russia

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Jeddah, 21423, Saudi Arabia

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Riyadh, 11426, Saudi Arabia

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Riyadh, 11525, Saudi Arabia

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Riyadh, 12372, Saudi Arabia

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Dolný Kubín, 02614, Slovakia

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Levoča, 054 01, Slovakia

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Liptovský Mikuláš, 031 23, Slovakia

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Martin, 03659, Slovakia

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Nitra, 949 01, Slovakia

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Rimavská Sobota, 97912, Slovakia

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Skalica, 909 82, Slovakia

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Spišská Nová Ves, 052 01, Slovakia

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Trenčín, 81171, Slovakia

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Trnava, 91701, Slovakia

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Žiar nad Hronom, 96537, Slovakia

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Anyang-si, 14068, South Korea

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Busan, 49201, South Korea

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Busan, 49241, South Korea

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Cheongju-si, 28644, South Korea

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Daegu, 42415, South Korea

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Daegu, 42601, South Korea

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Daegu, 700-721, South Korea

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Daejeon, 35233, South Korea

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Goyang-si, 411-706, South Korea

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Gwangju, 61469, South Korea

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Incheon, 400-711, South Korea

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Jeju-do, 63241, South Korea

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Seongnam-si, 13620, South Korea

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Seoul, 01830, South Korea

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Seoul, 02053, South Korea

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Seoul, 02447, South Korea

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Seoul, 04401, South Korea

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Albacete, 02006, Spain

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Alicante, 03010, Spain

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Badalona(Barcelona), 08916, Spain

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Barcelona, 08003, Spain

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Barcelona, 08025, Spain

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Barcelona, 08035, Spain

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Girona, 17007, Spain

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Lleida, 25198, Spain

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Madrid, 28006, Spain

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Madrid, 28034, Spain

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Seville, 41009, Spain

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Seville, 41013, Spain

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Valencia, 46009, Spain

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Valladolid, 47005, Spain

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Zaragoza, 50009, Spain

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Gothenburg, 413 45, Sweden

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Linköping, 581 85, Sweden

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Lund, 221 85, Sweden

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Malmo, 205 02, Sweden

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Östersund, 831 83, Sweden

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Skövde, 541 85, Sweden

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Solna, 171 76, Sweden

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Stockholm, 118 83, Sweden

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Stockholm, 182 88, Sweden

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Uppsala, 751 85, Sweden

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Changhua, 500, Taiwan

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Kaohsiung City, 80756, Taiwan

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Kaohsiung City, 83301, Taiwan

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Keelung, 20448, Taiwan

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New Taipei City, 23561, Taiwan

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New Taipei City, 237, Taiwan

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Taichung, 40447, Taiwan

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Taichung, 40705, Taiwan

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Taichung, 437, Taiwan

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Tainan, 704, Taiwan

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Tainan, 710, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 10449, Taiwan

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Taipei, 11101, Taiwan

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Taipei, 116, Taiwan

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Taoyuan Hsien, 33305, Taiwan

Location

Research Site

Bangkok, 10220, Thailand

Location

Research Site

Bangkok, 10300, Thailand

Location

Research Site

Bangkok, 10330, Thailand

Location

Research Site

Bangkok, 10400, Thailand

Location

Research Site

Bangkok, 10600, Thailand

Location

Research Site

Bangkok, 10700, Thailand

Location

Research Site

Chon Buri, 20000, Thailand

Location

Research Site

Hat Yai, 90110, Thailand

Location

Research Site

Khlong Luang, 12120, Thailand

Location

Research Site

Khon Kaen, 40002, Thailand

Location

Research Site

Lampang, 52000, Thailand

Location

Research Site

Muang, 57000, Thailand

Location

Research Site

Nakhonpathom, 73000, Thailand

Location

Research Site

Prachinburi, 25000, Thailand

Location

Research Site

Rajthevi, 10400, Thailand

Location

Research Site

Ratchaburi, 70000, Thailand

Location

Research Site

Ubonratchathani, 34000, Thailand

Location

Research Site

Chernivtsі, 58001, Ukraine

Location

Research Site

Ivano-Frankivsk, 76008, Ukraine

Location

Research Site

Ivano-Frankivsk, 76018, Ukraine

Location

Research Site

Kharkiv Region, 61018, Ukraine

Location

Research Site

Kharkiv Region, 61176, Ukraine

Location

Research Site

Kherson, 73000, Ukraine

Location

Research Site

Kyiv, 03129, Ukraine

Location

Research Site

Lutsk, 43024, Ukraine

Location

Research Site

Lviv, 79013, Ukraine

Location

Research Site

Poltava, 36038, Ukraine

Location

Research Site

Ternopil, 46027, Ukraine

Location

Research Site

Vinnytsia, 21005, Ukraine

Location

Research Site

Zaporizhzhia, 69068, Ukraine

Location

Research Site

Zaporizhzhia, 69600, Ukraine

Location

Research Site

Hanoi, 10000, Vietnam

Location

Research Site

Hà Nội, 10000, Vietnam

Location

Research Site

Ho Chi Minh City, 70000, Vietnam

Location

Research Site

Đông Nãi, 81000, Vietnam

Location

Related Publications (9)

  • Tank A, Johnston SC, Jain R, Amarenco P, Mellstrom C, Rikner K, Denison H, Ladenvall P, Knutsson M, Himmelmann A, Evans SR, James S, Molina CA, Wang Y, Ouwens M. Cost-effectiveness of ticagrelor plus aspirin versus aspirin in acute ischaemic stroke or transient ischaemic attack: an economic evaluation of the THALES trial. BMJ Neurol Open. 2023 Aug 24;5(2):e000478. doi: 10.1136/bmjno-2023-000478. eCollection 2023.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Ischemic Attack, TransientStroke

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Results Point of Contact

Title
Global Clinical Lead
Organization
Study Information Center

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 28, 2017

Study Start

January 22, 2018

Primary Completion

December 13, 2019

Study Completion

December 13, 2019

Last Updated

December 22, 2020

Results First Posted

December 22, 2020

Record last verified: 2020-12

Locations