Study to prevent major vascular events with Ticagrelor compared to Aspirin in patients with Acute Ischaemic Stroke or TIA

Phase 1

• Conditions: ischaemic stroke; MedDRA version: 16.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-003895-38-IT
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-07
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9600

Inclusion Criteria

Men or women equal or elder 40 years of age - Either acute ischaemic stroke not eligible for thrombolysis or mechanical thrombectomy or high-risk TIA as defined here and randomisation occurring within 24 hours after onset of symptoms
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2800

Exclusion Criteria

Planned use of antithrombotic therapy in addition to study medication including antiplatelets (eg, open label ASA, 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). - Any history of atrial fibrillation, ventricular aneurysm or suspicion of cardioembolic pathology for TIA or
stroke. - Planned carotid, cerebrovascular, or coronary revascularisation that requires halting study medication within 7 days of randomisation. - Receipt of any intravenous or intra-arterial thrombolysis
or mechanical thrombectomy within 24 hours prior to randomisation - 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified