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

Not Applicable

• Conditions: -I63-I67; I63; I67

• Registration Number: PER-036-17
• Lead Sponsor: AstraZeneca AB,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-09
• Study Completion: 2019-12-05
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

For inclusion in the study, patients should fulfil the following 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
(a)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 of 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
(b)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

Please refer to page 17 on CSP

Exclusion Criteria

Patients fulfilling any of the exclusion criteria must not be randomised.
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

Please refer to page 18 on CSP

Study & Design

• Study Type: Interventional
• Study Design: Not specified