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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03354429




Registration number
NCT03354429
Ethics application status
Date submitted
20/11/2017
Date registered
28/11/2017
Date last updated
26/12/2019

Titles & IDs
Public title
THALES - Acute STroke or Transient IscHaemic Attack Treated With TicAgreLor and ASA for PrEvention of Stroke and Death
Scientific title
A Randomised, Double-Blind, Placebo-Controlled, International, Multicentre, Phase III Study to Investigate the Efficacy and Safety of Ticagrelor and ASA Compared With ASA in the Prevention of Stroke and Death in Patients With Acute Ischaemic Stroke or Transient Ischaemic Attack
Secondary ID [1] 0 0
2016-004232-37
Secondary ID [2] 0 0
D5134C00003
Universal Trial Number (UTN)
Trial acronym
THALES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischaemic Stroke 0 0
Transient Ischaemic Attack 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ticagrelor
Treatment: Drugs - Placebo

Experimental: TICAGRELOR -

Placebo Comparator: TICAGRELOR PLACEBO -


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

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time from randomisation to first subsequent stroke or death - 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
Timepoint [1] 0 0
Day1-Day30
Secondary outcome [1] 0 0
Time from randomisation to first subsequent ischaemic stroke - 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
Timepoint [1] 0 0
Day1-Day30
Secondary outcome [2] 0 0
The modified Rankin Scale (mRS) score >1 at Visit 3 - 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.
Timepoint [2] 0 0
Day30

Eligibility
Key inclusion criteria
1. Provision of signed informed consent prior to any study-specific procedure

2. =40 years of age

3. Acute onset of cerebral ischaemia due to

1. AIS with NIHSS =5. AIS is defined as acute onset of neurological deficit
attributed to focal brain ischaemia, and either of the following:

- Persistent signs or symptoms of the ischaemic event at the time o
randomisation, OR

- Acute ischaemic brain lesion documented before randomisation by computed
tomography (CT) scan or magnetic resonance imaging (MRI) (diffusion-weighted
imaging) and that could account for the clinical presentation

2. High-risk TIA, defined as neurological deficit of acute onset attributed to focal
ischaemia of the brain by history or examination with complete resolution of the
deficit, and at least one of the following:

- ABCD2 score =6 and TIA symptoms not limited to isolated numbness, isolated
visual changes, or isolated dizziness/vertigo

- Symptomatic intracranial arterial occlusive disease that could account for
the clinical presentation, documented by transcranial Doppler or vascular
imaging and defined as at least 50% narrowing in the diameter of the vessel
lumen

- Internal carotid arterial occlusive disease that could account for the
clinical presentation, documented by Doppler, ultrasound, or vascular
imaging and defined as at least 50% narrowing in diameter of the vessel
lumen

4. Randomisation occurring within 24 hours after onset of symptoms; for wake-up strokes
(when the time of symptom onset is not known), within 24 hours from the time point at
which the patient was reported to be in their normal condition

5. CT or MRI performed after symptom onset ruling out intracranial haemorrhage or other
pathology, such as vascular malformation, tumour, or abscess that according

to the Investigator could explain symptoms or contraindicate study treatment
Minimum age
40 Years
Maximum age
130 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Need for or an anticipated need for any of the following:

1. Dual antiplatelet therapy with ASA and P2Y12 inhibitors (including patients with
carotid artery stenting and percutaneous coronary intervention)

2. Antiplatelets other than ASA (eg, GPIIb/IIIa inhibitors, clopidogrel,
ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol, ticagrelor) and other
antithrombotic agents with antiplatelet effects, including traditional/herbal
medicine agents

3. Anticoagulants (eg, warfarin, oral thrombin and factor Xa inhibitors,
bivalirudin, hirudin, argatroban, fondaparinux, or unfractionated heparin and
long-term treatment with low-molecular weight heparins). Short-term treatment (=7
days) with low-dose low-molecular weight heparin may be used in immobilised
patients at the discretion of the Investigator

2. Any history of atrial fibrillation/flutter, ventricular aneurysm, or suspicion of
other cardioembolic pathology for TIA or stroke

3. Patients who should receive or have received any intravenous or intra-arterial
thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation

4. Planned carotid endarterectomy that requires halting investigational product within 3
days of randomisation or is expected to require unblinding of investigational product
(planned carotid endarterectomy is in itself not an exclusion criterion)

5. History of previous intracranial haemorrhage at any time (asymptomatic microbleeds do
not qualify), gastrointestinal haemorrhage within the past 6 months, or major surgery
within 30 days

6. Patients considered to be at risk of bradycardic events (eg, known sick sinus syndrome
or second- or third-degree atrioventricular block) unless already treated with a
permanent pacemaker

7. Inability of the patient to understand and/or comply with study procedures and/or
follow-up, in the opinion of the Investigator

8. Known hypersensitivity to ticagrelor or ASA

9. Need for or an anticipated need for oral or intravenous therapy with any of the
following:

1. Strong cytochrome P450 3A (CYP3A4) inhibitors (eg, ketoconazole, clarithromycin
[but not erythromycin or azithromycin], nefazadone, ritonavir, atazanavir) that
cannot be stopped for the course of the study

2. Long-term (>7 days) non-steroidal anti-inflammatory drugs

10. Known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic
purpura)

11. Known severe liver disease (eg, ascites or signs of coagulopathy)

12. Renal failure requiring dialysis

13. Pregnancy or breastfeeding. Women of child-bearing potential who are not willing to
use a medically accepted method of contraception that is considered reliable in the
judgment of the Investigator

14. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
staff and/or staff at the study site)

15. Previous enrolment or randomisation in the present study

16. Participation in another clinical study with an investigational product at any time
during the 30 days prior to randomisation (regardless of when treatment with the
investigational product was discontinued)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Heidelberg
Recruitment hospital [3] 0 0
Research Site - Herston
Recruitment hospital [4] 0 0
Research Site - Parkville
Recruitment hospital [5] 0 0
Research Site - Southport
Recruitment hospital [6] 0 0
Research Site - St Albans
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Adrogué
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Argentina
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Buenos Aires
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Argentina
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Capital Federal
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Argentina
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Ciudad Autónoma de Bs. As.
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Argentina
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Cordoba
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Argentina
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Mar del Plata
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Argentina
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Mendoza
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Argentina
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Rosario
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Argentina
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Salta
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Belgium
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Antwerpen
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Belgium
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Assebroek (Brugge)
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Belgium
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Bruges
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Belgium
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Brussels
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Belgium
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Dendermonde
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Belgium
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Edegem
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Liège
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Belgium
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Oostende
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Belgium
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Roeselare
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Belgium
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Sint-Truiden
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Belgium
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Yvoir
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Brazil
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Botucatu
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Brazil
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Curitiba
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Brazil
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Goiania
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Joinville
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Maringa
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Porto Alegre
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Brazil
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Ribeirao Preto
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Brazil
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Rio de Janeiro
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Brazil
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Salvador
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Bulgaria
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Brest Cedex 2
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Caen
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Corbeil Essonnes Cedex
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Dijon
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Le Chesnay Cedex
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Lille
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Metz
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Montpellier Cedex 5
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Nancy
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NICE Cedex 01
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Paris Cedex 13
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Paris Cedex 18
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Paris
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Pringy Cedex
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Rennes
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Rouen Cedex
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Hamburg
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Hannover
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Germany
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Baja
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Gyor
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Kistarcsa
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Miskolc
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Nyíregyháza
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Hungary
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Pécs
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Hungary
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Sopron-Balf
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Székesfehérvár
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India
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Guntur
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Nashik
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D.F
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Ho Chi Minh

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

Ethics approval
Ethics application status

Summary
Brief summary
Study to investigate if the study drug ticagrelor and ASA is more effective than Placebo
(inactive tablet) and ASA in preventing new stroke events
Trial website
https://clinicaltrials.gov/show/NCT03354429
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications