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Clinical Trials List

Protocol NumberD5134C00003
NCT Number(ClinicalTrials.gov Identfier)NCT03354429

2018-01-22 - 2019-12-31

Phase III

Recruiting15

Study ended1

ICD-10Z82.3

Family history of stroke

ICD-10I63.10

Cerebral infarction due to embolism of unspecified precerebral artery

ICD-9V17.1

Family history of stroke ( cerebrovascular )

A Randomized, Double-Blinded, 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

  • Trial Applicant

  • Sponsor

    ASTRAZENECA TAIWAN LIMITED

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Chih-Hung Chen Division of Neurology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator 劉嘉為 Division of Neurology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林慧娟 Division of Neurology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Shih Huang Division of Neurology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Lung Chan Division of Neurology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 傅維仁 Division of Neurology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳大成 Division of Neurology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 連立明 Division of Neurology
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃雯怡 Division of Neurology
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chin-I Chen Division of Neurology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator PO-LIN CHEN Division of Neurology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 孫瑜 Division of Neurology
En Chu Kong Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 楊鈞百 Division of Neurology
Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsong-Hai Lee Division of Neurology
Linkou Chang Gung Medical Foundation

Taiwan National PI

李宗海

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

62 Recruiting

Audit

None

Principal Investigator Jiann-Shing Jeng Division of Neurology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Hsiu-Fen Lin Division of Neurology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

21 Study ended

Condition/Disease

Acute Ischemic Stroke or Transient ischaemic attack

Objectives

Primary objective:To demonstrate superior efficacy of ticagrelor and ASA compared with placebo and ASA in AIS/TIA patients in the prevention of subsequent stroke and death at 30 days.Secondary objective:To demonstrate superior efficacy of ticagrelor and ASA compared with placebo and ASA in AIS/TIA patients in the prevention of subsequent ischaemic stroke at 30 days To demonstrate superior efficacy of ticagrelor and ASA compared with placebo and ASA in AIS/TIA patients in reducing overall disability at 30 days

Test Drug

BRILINTA

Active Ingredient

Ticagrelor

Dosage Form

film-coated tablet

Dosage

90mg

Endpoints

1.Time from randomisation to first subsequent stroke or death
2.Time from randomisation to first subsequent ischaemic stroke
3.mRS score >1 at 30 days (Visit 3)

Inclution Criteria

Inclusion criteria
1.Informed consent
2.Men or women ≥40 years of age
3.Acute onset of cerebral ischaemia due to AIS with NIHSS ≤5 or High-risk TIA
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 reported being in a normal condition.
5.Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy

Exclusion Criteria

1.Need for or an anticipated need for any of the following:
(a) Dual antiplatelet therapy with ASA and P2Y12 inhibitors (including patients with carotid artery stenting and percutaneous coronary intervention)
(b) 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
(c) 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 randomization
4.Planned carotid endarterectomy that requires halting investigational product within 3 days of randomization 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:
(a)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
(b)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)

The Estimated Number of Participants

  • Taiwan

    230 participants

  • Global

    11000 participants

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