ClinicalTrials.gg
Sign In
CompletedNCT03354429THALESUpdated Dec 22, 2020Results posted

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

A Phase 3 interventional study of Ticagrelor and Placebo in Acute Ischaemic Stroke and Transient Ischaemic Attack, sponsored by AstraZeneca. Completed at 388 sites in 28 countries. Open to participants aged 40 Years to 130 Years. Per ClinicalTrials.gov, last updated 2020-12-22.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
11,016
Allocation
Randomized
Ages
40 Years to 130 Years
Sex
All
01

Study 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

02

Conditions studied

  • Acute Ischaemic Stroke
  • Transient Ischaemic Attack

Keywords

  • Acute ischaemic stroke; Transient Ischaemic Attack (TIA); Stroke
03

In context

Ischemic Attack, Transient

329 studies on the registry are indexed under Ischemic Attack, Transient; 71 are open to participants now.

This study's enrollment of 11,016 is above the median of 217 across 178 interventional studies indexed under Ischemic Attack, Transient.

Browse Ischemic Attack, Transient studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 130 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Provision of signed 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 , 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

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 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 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 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 () 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 who are not willing to use a medically accepted method of 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)
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
11,016 participants (actual)

Study arms

  • Experimental
    TICAGRELOR

    Drug: Ticagrelor

  • Placebo comparator
    TICAGRELOR PLACEBO

    Drug: Placebo

Interventions

  • DrugTicagrelor

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Composite of Subsequent Stroke or Death

    Participants with subsequent stroke or death

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

Secondary outcomes

  1. Ischaemic Stroke

    Number of participants with ischaemic stroke

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

  2. Number of Participants With Modified Rankin Scale (mRS) Score >1 at Visit 3

    The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.0 - No symptoms,1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.

    Time frame: Visit 3 (day 30-34)

Other outcomes

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

    Participants with bleeding event that fulfils serious adverse event criteria and is categorised as GUSTO Severe. GUSTO is a bleeding scale (GUSTO = Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries). GUSTO Severe bleeding is defined as any of the following: (1) fatal bleeding, (2) intracranial bleeding, or (3) bleeding that caused haemodynamic compromise requiring intervention

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

  2. ICH or Fatal Bleeding Event

    Participants with ICH or fatal bleeding event

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

  3. Bleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Moderate/Severe

    Participants with bleeding event that fulfils serious adverse event criteria and is categorised as GUSTO Moderate/Severe. GUSTO is a bleeding scale (GUSTO = Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries). GUSTO Severe bleeding is defined as any of the following: (1) fatal bleeding, (2) intracranial bleeding, or (3) bleeding that caused haemodynamic compromise requiring intervention. GUSTO Moderate bleeding is a bleeding requiring transfusion of whole blood or packed red blood cells without haemodynamic compromise

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

  4. Premature Permanent Discontinuation of IP Due to Bleeding

    Participants with premature permanent discontinuation of IP due to bleeding

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

07

Results

Posted Dec 22, 2020

Participant flow

414 study sites in 28 countries enrolled patients. The first patient was enrolled on 22 January 2018. The last patient visit took place on 13 December 2019.

Participant flow — Overall Study
MilestoneTICAGRELORPLACEBO
Started55235493
Completed55145486
Not completed97
Withdrew: Withdrawal by subject87
Withdrew: Lost to follow-up10

Outcome measures

PrimaryComposite of Subsequent Stroke or Death

Participants with subsequent stroke or death

Time frame:
From randomisation (day 1) to visit 3 (day 30-34)
Reported as:
Count of participants · Participants
Composite of Subsequent Stroke or Death
ParticipantsTICAGRELORPLACEBO
Composite of Subsequent Stroke or Death303362
Statistical analysis
  • TICAGRELOR vs PLACEBO · Regression, Cox · p = 0.015 (The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing) · Hazard ratio (hr): 0.83 · 95% CI 0.71 to 0.96Placebo is the reference group (denominator)
SecondaryIschaemic Stroke

Number of participants with ischaemic stroke

Time frame:
From randomisation (day 1) to visit 3 (day 30-34)
Reported as:
Count of participants · Participants
Ischaemic Stroke
ParticipantsTICAGRELORPLACEBO
Ischaemic Stroke276345
Statistical analysis
  • TICAGRELOR vs PLACEBO · Regression, Cox · p = 0.004 (The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing) · Hazard ratio (hr): 0.79 · 95% CI 0.68 to 0.93Placebo is the reference group (denominator)
SecondaryNumber of Participants With Modified Rankin Scale (mRS) Score >1 at Visit 3

The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.0 - No symptoms,1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.

Time frame:
Visit 3 (day 30-34)
Reported as:
Count of participants · Participants
Number of Participants With Modified Rankin Scale (mRS) Score >1 at Visit 3
ParticipantsTICAGRELORPLACEBO
Number of Participants With Modified Rankin Scale (mRS) Score >1 at Visit 312821284
Statistical analysis
  • TICAGRELOR vs PLACEBO · Regression, Logistic · p = 0.613 (The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing) · Odds ratio (or): 0.98 · 95% CI 0.89 to 1.07Placebo is the reference group (denominator)
Other pre-specifiedBleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Severe

Participants with bleeding event that fulfils serious adverse event criteria and is categorised as GUSTO Severe. GUSTO is a bleeding scale (GUSTO = Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries). GUSTO Severe bleeding is defined as any of the following: (1) fatal bleeding, (2) intracranial bleeding, or (3) bleeding that caused haemodynamic compromise requiring intervention

Time frame:
From randomisation (day 1) to visit 3 (day 30-34)
Reported as:
Count of participants · Participants
Bleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Severe
ParticipantsTICAGRELORPLACEBO
Bleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Severe287
Statistical analysis
  • TICAGRELOR vs PLACEBO · Regression, Cox · p = 0.001 · Hazard ratio (hr): 3.99 · 95% CI 1.74 to 9.14Placebo is the reference group (denominator)
Other pre-specifiedICH or Fatal Bleeding Event

Participants with ICH or fatal bleeding event

Time frame:
From randomisation (day 1) to visit 3 (day 30-34)
Reported as:
Count of participants · Participants
ICH or Fatal Bleeding Event
ParticipantsTICAGRELORPLACEBO
ICH or Fatal Bleeding Event226
Statistical analysis
  • TICAGRELOR vs PLACEBO · Regression, Cox · p = 0.005 · Hazard ratio (hr): 3.66 · 95% CI 1.48 to 9.02Placebo is the reference group (denominator)
Other pre-specifiedBleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Moderate/Severe

Participants with bleeding event that fulfils serious adverse event criteria and is categorised as GUSTO Moderate/Severe. GUSTO is a bleeding scale (GUSTO = Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries). GUSTO Severe bleeding is defined as any of the following: (1) fatal bleeding, (2) intracranial bleeding, or (3) bleeding that caused haemodynamic compromise requiring intervention. GUSTO Moderate bleeding is a bleeding requiring transfusion of whole blood or packed red blood cells without haemodynamic compromise

Time frame:
From randomisation (day 1) to visit 3 (day 30-34)
Reported as:
Count of participants · Participants
Bleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Moderate/Severe
ParticipantsTICAGRELORPLACEBO
Bleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Moderate/Severe3611
Statistical analysis
  • TICAGRELOR vs PLACEBO · Regression, Cox · p = <0.001 · Hazard ratio (hr): 3.27 · 95% CI 1.67 to 6.43Placebo is the reference group (denominator)
Other pre-specifiedPremature Permanent Discontinuation of IP Due to Bleeding

Participants with premature permanent discontinuation of IP due to bleeding

Time frame:
From randomisation (day 1) to visit 3 (day 30-34)
Reported as:
Count of participants · Participants
Premature Permanent Discontinuation of IP Due to Bleeding
ParticipantsTICAGRELORPLACEBO
Premature Permanent Discontinuation of IP Due to Bleeding15232
Statistical analysis
  • TICAGRELOR vs PLACEBO · Regression, Cox · p = <0.001 · Hazard ratio (hr): 4.80 · 95% CI 3.28 to 7.02Placebo is the reference group (denominator)

Adverse events

Collected over From randomisation (day 1) to visit 3 (day 30-34). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ticagrelor40/5,523 (0.7%)571/5,523 (10.3%)0/5,523 (0%)
Placebo32/5,493 (0.6%)609/5,493 (11.1%)0/5,493 (0%)
Most frequent serious events
Showing 10 of 338
Most frequent serious events
EventTicagrelorPlacebo
Ischaemic strokeNervous system disorders254/5523324/5493
Transient ischaemic attackNervous system disorders12/552330/5493
PneumoniaInfections and infestations25/552328/5493
Atrial fibrillationCardiac disorders18/552315/5493
Pulmonary embolismRespiratory, thoracic and mediastinal disorders9/55235/5493
Cerebral infarctionNervous system disorders6/55238/5493
Carotid artery stenosisNervous system disorders8/55237/5493
Haemorrhagic transformation strokeNervous system disorders8/55236/5493
HaematuriaRenal and urinary disorders8/55231/5493
Urinary tract infectionInfections and infestations6/55237/5493

Baseline characteristics

Full analysis set including all randomised patients

Age, Continuous
Age, Continuous(Years)TICAGRELORPLACEBOTotal
Mean65.2 ± 11.065.1 ± 11.165.1 ± 11.0
Sex: Female, Male
Sex: Female, Male(Participants)TICAGRELORPLACEBOTotal
Female210821714279
Male341533226737
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)TICAGRELORPLACEBOTotal
White297329485921
Black or African American213253
Asian235323394692
Native Hawaiian or other Pacific Islander134
American Indian or Alaska Native173168341
Other235
08

Study locations

388 sites
  • Research Site
    Adrogué, 1846, Argentina
  • Research Site
    Buenos Aires, 1180AAX, Argentina
  • Research Site
    Buenos Aires, 1437, Argentina
  • Research Site
    Buenos Aires, AR-CP 1221, Argentina
  • Research Site
    Buenos Aires, C1425 FSD, Argentina
  • Research Site
    Buenos Aires, C1437BZK, Argentina
  • Research Site
    Capital Federal, 1428, Argentina
  • Research Site
    Ciudad Autónoma de Bs. As., C1199ABB, Argentina
  • Research Site
    Cordoba, 5000, Argentina
  • Research Site
    Mar del Plata, B7602CBM, Argentina
  • Research Site
    Mendoza, M5500IDN, Argentina
  • Research Site
    Rosario, S2000DSV, Argentina
  • Research Site
    Rosario, S200GAP, Argentina
  • Research Site
    Salta, A4400, Argentina
  • Research Site
    Adelaide, 5000, Australia
  • Research Site
    Heidelberg, 3084, Australia
  • Research Site
    Herston, 4029, Australia
  • Research Site
    Parkville, 3050, Australia
  • Research Site
    Southport, 4215, Australia
  • Research Site
    St Albans, 3021, Australia
  • Research Site
    Antwerpen, 2020, Belgium
  • Research Site
    Assebroek (Brugge), 8310, Belgium
  • Research Site
    Bruges, 8000, Belgium
  • Research Site
    Brussels, 1200, Belgium
  • Research Site
    Dendermonde, 9200, Belgium
  • Research Site
    Edegem, 2650, Belgium
  • Research Site
    Kortrijk, 8500, Belgium
  • Research Site
    Leuven, 3000, Belgium
  • Research Site
    Liège, 4000, Belgium
  • Research Site
    Oostende, 8400, Belgium
  • Research Site
    Roeselare, 8800, Belgium
  • Research Site
    Sint-Truiden, 3800, Belgium
  • Research Site
    Yvoir, 5530, Belgium
  • Research Site
    Botucatu, 18618-687, Brazil
  • Research Site
    Curitiba, 81210-310, Brazil
  • Research Site
    Goiania, 74083-100, Brazil
  • Research Site
    Joinville, 89202-165, Brazil
  • Research Site
    Maringa, 87015-000, Brazil
  • Research Site
    Porto Alegre, 90610-000, Brazil
  • Research Site
    Ribeirao Preto, 14015130, Brazil
  • Research Site
    Rio de Janeiro, 22270-005, Brazil
  • Research Site
    Salvador, 41820011, Brazil
  • Research Site
    Dupnitsa, 2600, Bulgaria
  • Research Site
    Kozloduy, 3320, Bulgaria
  • Research Site
    Lukovit, 5770, Bulgaria
  • Research Site
    Pazardzhik, 4400, Bulgaria
  • Research Site
    Pleven, 5800, Bulgaria
  • Research Site
    Sliven, 8800, Bulgaria
  • Research Site
    Sofia, 1142, Bulgaria
  • Research Site
    Sofia, 1407, Bulgaria
  • Research Site
    Sofia, 1606, Bulgaria
  • Research Site
    Teteven, 5700, Bulgaria
  • Research Site
    Calgary, Alberta T2N 2T9, Canada
  • Research Site
    Edmonton, Alberta T6G 2B7, Canada
  • Research Site
    Lethbridge, Alberta T1J 0N9, Canada
  • Research Site
    Chicoutimi, G7H 5H6, Canada
  • Research Site
    Baoji, 721008, China
  • Research Site
    Baotou, 014016, China
  • Research Site
    Beijing, 100049, China
  • Research Site
    Beijing, 100070, China
  • Research Site
    Beijing, 100191, China
  • Research Site
    Changsha, 410013, China
  • Research Site
    Changsha, 410078, China
  • Research Site
    Changsha, 430033, China
  • Research Site
    Chifeng, 024000, China
  • Research Site
    Daqing, 163000, China
  • Research Site
    Foshan, 528000, China
  • Research Site
    Guangzhou, 510080, China
  • Research Site
    Guangzhou, 510180, China
  • Research Site
    Guangzhou, 510630, China
  • Research Site
    Guiyang, 550004, China
  • Research Site
    Haikou, 570311, China
  • Research Site
    Hangzhou, 310009, China
  • Research Site
    Hohhot, 010017, China
  • Research Site
    Hohhot, 10050, China
  • Research Site
    Jinan, 250001, China
  • Research Site
    Jinzhou, 121004, China
  • Research Site
    Liuzhou, 545006, China
  • Research Site
    Nanchang, 330006, China
  • Research Site
    Nanjing, 210029, China
  • Research Site
    Nantong, 226001, China
  • Research Site
    Ningbo, 315010, China
  • Research Site
    Shanghai, 200080, China
  • Research Site
    Shanghai, 200090, China
  • Research Site
    Shanghai, CN-200120, China
  • Research Site
    Shenyang, 110016, China
  • Research Site
    Taiyuan, 030001, China
  • Research Site
    Tangshan, 063001, China
  • Research Site
    Tianjin, 300060, China
  • Research Site
    Tianjin, 300121, China
  • Research Site
    Wenzhou, 325000, China
  • Research Site
    Wu Han, 430060, China
  • Research Site
    Wuhan, 430022, China
  • Research Site
    Wuhan, 430033, China
  • Research Site
    Wuxi, 214002, China
  • Research Site
    Xi'an, 710061, China
  • Research Site
    Xiamen, 361004, China
  • Research Site
    Xining, 810001, China
  • Research Site
    Xuzhou, 221006, China
  • Research Site
    Brno, 656 91, Czechia

Showing the first 100 of 388 sites across 28 countries. Choose a country and city above to see the rest.

09

References and documents

Publications

  • Johnston SC, Amarenco P, Aunes M, Denison H, Evans SR, Himmelmann A, Jahreskog M, James S, Knutsson M, Ladenvall P, Molina CA, Nylander S, Rother J, Wang Y; THALES Investigators. Ischemic Benefit and Hemorrhage Risk of Ticagrelor-Aspirin Versus Aspirin in Patients With Acute Ischemic Stroke or Transient Ischemic Attack. Stroke. 2021 Nov;52(11):3482-3489. doi: 10.1161/STROKEAHA.121.035555. Epub 2021 Sep 3. PubMed 34477459 ↗
  • 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. PubMed 34244703 ↗
  • 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. PubMed 33940954 ↗
  • 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. PubMed 33198608 ↗
  • Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y, Johnston SC; THALES Steering Committee and Investigators. Ticagrelor Added to Aspirin in Acute Ischemic Stroke or Transient Ischemic Attack in Prevention of Disabling Stroke: A Randomized Clinical Trial. JAMA Neurol. 2020 Nov 7;78(2):1-9. doi: 10.1001/jamaneurol.2020.4396. Online ahead of print. Erratum In: JAMA Neurol. 2021 Feb 1;78(2):253. doi: 10.1001/jamaneurol.2020.4906. PubMed 33159526 ↗
  • 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. PubMed 32668111 ↗
  • 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. PubMed 30747613 ↗
  • 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. PubMed 29915123 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Dec 2019, 22 months.

Results were first posted in Dec 2020, 1 year after primary completion.

Of 13 phase 3 interventional studies under Ischemic Attack, Transient, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 51. This study's 22 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2017
First posted
Nov 28, 2017
StartActual
Jan 22, 2018
Primary completionActual
Dec 13, 2019
CompletionActual
Dec 13, 2019
Results first posted
Dec 22, 2020
Last update
Dec 22, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03354429
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Nov 28, 2017
Start date
Jan 22, 2018
Primary completion
Dec 13, 2019
Completion
Dec 13, 2019
Results posted
Dec 22, 2020
Last update
Dec 22, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ticagrelor

Other studies in this condition

Ischemic Attack, Transient →

Other studies from this sponsor

AstraZeneca →

Start the discussion