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Clinical Trials List

Protocol NumberD5134C00001
NCT Number(ClinicalTrials.gov Identfier)NCT01994720

2014-02-01 - 2016-01-31

Phase III

Terminated10

Study ended1

Acute Stroke Or Transient IsChemic Attack TReated with Aspirin or Ticagrelor and Patient OutcomES

  • Trial Applicant

  • Sponsor

    AstraZeneca Taiwan

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

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 Terminated

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 Terminated

Principal Investigator Chung-Hsiang Liu Division of Neurology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 巫錫霖 Division of Neurology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 李建德 Division of Neurology
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林慧娟 Division of Neurology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 陳偉熹 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 Terminated

Principal Investigator 孫瑜 Division of Neurology
En Chu Kong Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Lin Ruey-Tay Division of Neurology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

28 Study ended

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Patients with an acute cerebral ischemic event (minor stroke/high-risk TIA) and high risk of subsequent ischemic stroke, who could be randomised within 24 hours of symptom onset

Objectives

To compare the effect of 90-day treatment with ticagrelor 180 mg vs acetylsalicylic acid (ASA 300mg) for prevention of the composite of stroke, myocardial infarction (MI) and death in patients with acute ischemic stroke or TIA

Test Drug

Ticagrelor

Active Ingredient

Ticagrelor

Dosage Form

tablet

Dosage

90 mg

Endpoints

Primary efficacy variable:
time from randomisation to first occurrence of any event from the composite of all strokes (ischemic or hemorrhagic), MI and all cause death
Safety Objective
1.Time to first major bleeding event using the PLATO study definition
2.Time to discontinuation of study medication due to any bleeding event

Inclution Criteria

1.Provision of written informed consent
2.Men or women ≥40 years of age
3.Either acute ischemic stroke OR high-risk TIA (study specific definitions) and randomisation within 24 hours after onset of symptoms
4.Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy

*Acute ischemic stroke, defined as:
1.Neurological deficit attributed to the focal brain ischemia, and either of the following:
•Persistent signs or symptoms of the ischemic event at the time of randomisation OR
•Acute, ischemic brain lesion documented by computed tomography scan or magnetic resonance imaging (diffusion-weighted imaging) within 24 hours of onset of symptoms
2.National Institute of Health Stroke Score (NIHSS) ≤5
Inclusion Criteria
*High-risk TIA, defined as: Neurological deficit of acute onset attributed to focal ischemia of the brain by history or examination
with complete resolution of the deficit, and at least one of the following:
•ABCD2 score ≥4 and TIA symptoms not limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo
•Symptomatic intracranial arterial occlusive disease documented by transcranial doppler, ultrasound or vascular imaging, defined as at least 50% narrowing in diameter of a vessel that could account for the clinical presentation
•Documented internal carotid arterial occlusive disease, defined as at least 50% narrowing in diameter of a vessel that could account for the clinical presentation

Exclusion Criteria

Exclusion Criteria
1. Planned use of:
*Antithrombotic therapy in addition to study medication including antiplatelets (eg, open label aspirin, GPIIb/IIIa inhibitors, clopidogrel, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol) and
*Anticoagulants (eg, warfarin, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, unfractionated and low molecular weight heparins)
In addition, patients receiving or requiring dual antiplatelet therapy with aspirin and P2Y12 inhibitors will be excluded
2.Known hypersensitivity to ticagrelor or aspirin
3.Any history of atrial fibrillation, ventricular aneurysm or suspicion of cardioembolic pathology for TIA or stroke
4.Planned carotid, cerebrovascular, or coronary revascularisation that requires halting study medication within 7 days of randomisation
5.Receipt of any intravenous or intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation
6.Anticipated concomitant oral or intravenous therapy with strong cytochrome P450 3A (CYP3A) inhibitors or CYP3A substrates with narrow therapeutic indices that cannot be stopped for the course of the study
.Strong CYP3A inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir
.CYP3A substrates with narrow therapeutic index: cyclosporine, quinidine, simvastatin or lovastatin at dose >40 mg daily
7.Anticipated requirement for long-term (>7 days) non-steroidal anti-inflammatory drugs (NSAIDs)
8.Patients with known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura)
9.History of previous symptomatic non-traumatic intracerebral bleed at any time (asymptomatic microbleeds do not qualify), gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days
10.Known severe liver disease (eg, ascites or signs of coagulopathy)
11.Renal failure requiring dialysis
12.Pregnancy or lactation
13.Involvement in the planning and/or conduct of the study (applies to both AZ staff and/or staff at the study site)
14.Inability of the patient to understand and/or comply with study procedures and/or follow-up, in the opinion of the investigator*
15.Previous enrolment or randomization in the present study
16.Participation in another clinical study with an investigational product during the last 30 days

The Estimated Number of Participants

  • Taiwan

    252 participants

  • Global

    9600 participants

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