臨床研究等提出・公開システム

Date of registration	Mar. 20, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222431

Scientific Title	A Randomised, Double-Blind, Multinational Study to Prevent Major Vascular Events With Ticagrelor Compared to Aspirin (ASA) in Patients With Acute Ischaemic Stroke or TIA.
Public Title	SOCRATES

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	AstraZeneca KK
	Address	RD-clinical-information-Japan@astrazeneca.com
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Randomized, Safety/Efficacy Study, Parallel Assignment, Double Blind
Study Design	Objective
Phase		3
Key inclusion & exclusion 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
	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.
	Minimum Age	40age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Acute Ischaemic Stroke, Transient Ischaemic Attack
Intervention(s)		investigational material(s) Generic name etc : ticagrelor INN of investigational material : ticagrelor Therapeutic category code : 339 Other agents relating to blood and body fluides Dosage and Administration for Investigational material : 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily or corresponding placebo given orally. control material(s) Generic name etc : Acetylsalicylic acid (ASA) INN of investigational material : aspirin Therapeutic category code : 339 Other agents relating to blood and body fluides Dosage and Administration for Investigational material : ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily or corresponding placebo given orally.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	AstraZeneca
Secondary Sponsor

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Name of Research Funding

Name of IRB
Address of IRB
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E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-142481
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Oct. 14, 2016	Detail	Changes
5	Oct. 14, 2016	Detail	Changes
4	Jan. 15, 2016	Detail	Changes
3	Jan. 15, 2016	Detail	Changes
2	Mar. 20, 2014	Detail	Changes
1	Mar. 20, 2014	Detail

List of change history