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

A randomised, double-blind, multinational study to prevent major vascular events with Ticagrelor compared to Aspirin(ASA) in patients with acute ischaemic stroke or Transient Ischemic Attack (TIA). [SOCRATES - Acute Stroke Or Transient IsChaemic Attack TReated with Aspirin or Ticagrelor and Patients OutcomeS]. - SOCRATES

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003895-38-CZ

Enrollment

13600

Registered

2013-10-14

Start date

2014-02-11

Completion date

Unknown

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischaemic stroke MedDRA version: 18.0 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 100000004852

Interventions

Trade Name: BRILIQUE Product Name: Ticagrelor Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ticagrelor CAS Number: 274693-27-5 Current Sponsor code: AZD6140 Other descriptive name: TICA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men or women equal or elder 40 years of age - Either acute ischaemic stroke 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 9633 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3967

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs. acetylsalicylic acid (ASA)-aspirin (300 mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).;Secondary Objective: Compare the effects of treatment with ticagrelor vs. ASA on: 1) prevention of subsequent ischaemic stroke. 2) net clinical outcome (stroke + MI + death + life threatening bleeding). 3) prevention of composite of ischaemic stroke, MI and cardiovascular [CV] death. 4) prevention of all-cause death, CV death and MI, individually 5) severity of stroke and overall disability of patients using modified Rankin Scale 6) prevention of all stroke (including haemorrhagic stroke), fatal stroke and disabling stroke, individually. 7) health care resource and utilities assessed by Euro Quality of Life-5 Dimensions to support health technology assessment and health economic modelling.;Primary end point(s): Composite of stroke, MI and death.;Timepoint(s) of evaluation of this end point: From randomization for 2.5 year (min.treatment duration)	—

Measure

Time frame

Main Objective: The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs. acetylsalicylic acid (ASA)-aspirin (300 mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).;Secondary Objective: Compare the effects of treatment with ticagrelor vs. ASA on: 1) prevention of subsequent ischaemic stroke. 2) net clinical outcome (stroke + MI + death + life threatening bleeding). 3) prevention of composite of ischaemic stroke, MI and cardiovascular [CV] death. 4) prevention of all-cause death, CV death and MI, individually 5) severity of stroke and overall disability of patients using modified Rankin Scale 6) prevention of all stroke (including haemorrhagic stroke), fatal stroke and disabling stroke, individually. 7) health care resource and utilities assessed by Euro Quality of Life-5 Dimensions to support health technology assessment and health economic modelling.;Primary end point(s): Composite of stroke, MI and death.;Timepoint(s) of evaluation of this end point: From randomization for 2.5 year (min.treatment duration)

—

Secondary

Measure	Time frame
Secondary end point(s): Composite of ischaemic stroke, MI and CV death. Net clinical outcome. Time to discontinuation of study medication due to any bleeding event.;Timepoint(s) of evaluation of this end point: From randomization for 2.5 year (min.treatment duration)	—

Countries

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United States, Vietnam

Contacts

Public ContactInformation Centre

AstraZeneca

information.center@astrazeneca.com0018002369933

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026