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[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES] (SOCRATES)

Primary Purpose

Acute Ischaemic Stroke, Transient Ischaemic Attack

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ticagrelor
Acetylsalicylic acid (ASA)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Ischaemic Stroke focused on measuring Acute ischaemic stroke., Transient ischaemic attack.

Eligibility Criteria

40 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Key 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.

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ticagrelor

Acetylsalicylic acid (ASA)

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Composite of Stroke/MI/Death
Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).

Secondary Outcome Measures

Number of Participants With Ischaemic Stroke
Participants with ischaemic stroke. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).
Net Clinical Outcome
Participants with stroke, MI, death or life-threatening bleeding. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).
Number of Participants With Composite of Ischaemic Stroke, MI and CV Death
Participants with ischaemic stroke, MI or CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).
Number of Participants With All-Cause Death
Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97).
Number of Participants With CV Death
Participants with CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).
Number of Participants With MI
Participants with MI. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)
Number of Participants by Severity of Stroke and Overall Disability
Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS. Modified Rankin Score: 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. Disability defined as mRS > 1. Odds ratio and p-value are calculated for ticagrelor versus ASA from a logistic regression model with treatment group, history of stroke and NIHSS (National Institutes of Health Stroke Scale) at baseline as explanatory variables.
Number of Participants With Stroke
Participants with stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)
Number of Participants With Fatal Stroke
Participants with fatal stroke. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).
Number of Participants With Disabling Stroke
Participants with disabling stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).
Change in NIHSS
Change from baseline to end of treatment visit in NIHSS (National Institutes of Health Stroke Scale): 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke.
EQ-5D at Visit 1 (Enrolment)
EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.
EQ-5D at Visit 2 (Day 7+-2d)
EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.
EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit
EQ-5D index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.
EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit
EQ-5D index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.
Number of Participants With PLATO Major Bleeding Event
Participants with PLATO Major bleeding. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). PLATO Major bleeding is defined as a bleed that is any one of: Fatal Intracranial (excluding asymptomatic haemorrhagic transformations of ischemic brain infarctions and excluding micro-hemorrhages <10 mm evident only on gradient-echo MRI) Intrapericardial bleed with cardiac tamponade Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery Significantly disabling (eg. intraocular with permanent vision loss) Clinically overt or apparent bleeding associated with a decrease in Hb of more than 30 g/L (1.9 mmol/L; 0.465 mmol/L) Transfusion of 2 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding.
Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event
Participants discontinuation of study drug due to any bleeding adverse event. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

Full Information

First Posted
November 18, 2013
Last Updated
May 12, 2017
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01994720
Brief Title
[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]
Acronym
SOCRATES
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 7, 2014 (Actual)
Primary Completion Date
March 2, 2016 (Actual)
Study Completion Date
March 2, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischaemic Stroke, Transient Ischaemic Attack
Keywords
Acute ischaemic stroke., Transient ischaemic attack.

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ticagrelor
Arm Type
Experimental
Arm Title
Acetylsalicylic acid (ASA)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ticagrelor
Intervention Description
ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic acid (ASA)
Intervention Description
ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.
Primary Outcome Measure Information:
Title
Number of Participants With Composite of Stroke/MI/Death
Description
Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).
Time Frame
From randomization up to 97 days
Secondary Outcome Measure Information:
Title
Number of Participants With Ischaemic Stroke
Description
Participants with ischaemic stroke. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).
Time Frame
From randomization up to 97 days
Title
Net Clinical Outcome
Description
Participants with stroke, MI, death or life-threatening bleeding. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).
Time Frame
From randomization up to 97 days
Title
Number of Participants With Composite of Ischaemic Stroke, MI and CV Death
Description
Participants with ischaemic stroke, MI or CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).
Time Frame
From randomization up to 97 days
Title
Number of Participants With All-Cause Death
Description
Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97).
Time Frame
From randomization up to 97 days
Title
Number of Participants With CV Death
Description
Participants with CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).
Time Frame
From randomization up to 97 days
Title
Number of Participants With MI
Description
Participants with MI. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)
Time Frame
From randomization up to 97 days
Title
Number of Participants by Severity of Stroke and Overall Disability
Description
Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS. Modified Rankin Score: 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. Disability defined as mRS > 1. Odds ratio and p-value are calculated for ticagrelor versus ASA from a logistic regression model with treatment group, history of stroke and NIHSS (National Institutes of Health Stroke Scale) at baseline as explanatory variables.
Time Frame
From randomization up to 97 days
Title
Number of Participants With Stroke
Description
Participants with stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)
Time Frame
From randomization up to 97 days
Title
Number of Participants With Fatal Stroke
Description
Participants with fatal stroke. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).
Time Frame
From randomization up to 97 days
Title
Number of Participants With Disabling Stroke
Description
Participants with disabling stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).
Time Frame
From randomization up to 97 days
Title
Change in NIHSS
Description
Change from baseline to end of treatment visit in NIHSS (National Institutes of Health Stroke Scale): 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke.
Time Frame
From randomization up to 97 days
Title
EQ-5D at Visit 1 (Enrolment)
Description
EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.
Time Frame
Visit 1 (Enrolment)
Title
EQ-5D at Visit 2 (Day 7+-2d)
Description
EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.
Time Frame
Visit 2 (Day 7+-2d)
Title
EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit
Description
EQ-5D index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.
Time Frame
End of treatment visit (Day 90+-7d)
Title
EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit
Description
EQ-5D index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.
Time Frame
Premature treatment discontinuation visit(<15 days after last dose)
Title
Number of Participants With PLATO Major Bleeding Event
Description
Participants with PLATO Major bleeding. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). PLATO Major bleeding is defined as a bleed that is any one of: Fatal Intracranial (excluding asymptomatic haemorrhagic transformations of ischemic brain infarctions and excluding micro-hemorrhages <10 mm evident only on gradient-echo MRI) Intrapericardial bleed with cardiac tamponade Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery Significantly disabling (eg. intraocular with permanent vision loss) Clinically overt or apparent bleeding associated with a decrease in Hb of more than 30 g/L (1.9 mmol/L; 0.465 mmol/L) Transfusion of 2 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding.
Time Frame
From randomization up to 97 days
Title
Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event
Description
Participants discontinuation of study drug due to any bleeding adverse event. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).
Time Frame
Time from first dose and up to and including 7 days following the date of last dose of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility 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 Key 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.
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Hungary
Facility Name
Research Site
City
Nyíregyháza
Country
Hungary
Facility Name
Research Site
City
Pécs
Country
Hungary
Facility Name
Research Site
City
Sopron-Balf
Country
Hungary
Facility Name
Research Site
City
Szekszárd
Country
Hungary
Facility Name
Research Site
City
Székesfehérvár
Country
Hungary
Facility Name
Research Site
City
Haifa
Country
Israel
Facility Name
Research Site
City
Holon
Country
Israel
Facility Name
Research Site
City
Jerusalem
Country
Israel
Facility Name
Research Site
City
Petach Tikva
Country
Israel
Facility Name
Research Site
City
Ramat Gan
Country
Israel
Facility Name
Research Site
City
Tel Aviv
Country
Israel
Facility Name
Research Site
City
Carrara
Country
Italy
Facility Name
Research Site
City
Citta' di Castello
Country
Italy
Facility Name
Research Site
City
Foligno
Country
Italy
Facility Name
Research Site
City
Genova
Country
Italy
Facility Name
Research Site
City
Gubbio
Country
Italy
Facility Name
Research Site
City
Lecco
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Modena
Country
Italy
Facility Name
Research Site
City
Pavia
Country
Italy
Facility Name
Research Site
City
Perugia
Country
Italy
Facility Name
Research Site
City
Piacenza
Country
Italy
Facility Name
Research Site
City
Pisa
Country
Italy
Facility Name
Research Site
City
Reggio Emilia
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Rozzano
Country
Italy
Facility Name
Research Site
City
Siena
Country
Italy
Facility Name
Research Site
City
Varese
Country
Italy
Facility Name
Research Site
City
Verona
Country
Italy
Facility Name
Research Site
City
Vibo Valentia
Country
Italy
Facility Name
Research Site
City
Aki-gun
Country
Japan
Facility Name
Research Site
City
Asahikawa-shi
Country
Japan
Facility Name
Research Site
City
Chiba-shi
Country
Japan
Facility Name
Research Site
City
Chikushi-gun
Country
Japan
Facility Name
Research Site
City
Chikushino-shi
Country
Japan
Facility Name
Research Site
City
Chitose-shi
Country
Japan
Facility Name
Research Site
City
Daito-shi
Country
Japan
Facility Name
Research Site
City
Date-gun
Country
Japan
Facility Name
Research Site
City
Eniwa-shi
Country
Japan
Facility Name
Research Site
City
Fujinomiya-shi
Country
Japan
Facility Name
Research Site
City
Fukui-shi
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
Country
Japan
Facility Name
Research Site
City
Fukushima-shi
Country
Japan
Facility Name
Research Site
City
Fukuyama-shi
Country
Japan
Facility Name
Research Site
City
Gifu-shi
Country
Japan
Facility Name
Research Site
City
Hachioji-shi
Country
Japan
Facility Name
Research Site
City
Hakodate-shi
Country
Japan
Facility Name
Research Site
City
Hamada-shi
Country
Japan
Facility Name
Research Site
City
Hanamaki-shi
Country
Japan
Facility Name
Research Site
City
Hatsukaichi-shi
Country
Japan
Facility Name
Research Site
City
Hidaka-shi
Country
Japan
Facility Name
Research Site
City
Higashiibaraki-gun
Country
Japan
Facility Name
Research Site
City
Higashiosaka-shi
Country
Japan
Facility Name
Research Site
City
Hitachi-shi
Country
Japan
Facility Name
Research Site
City
Ina-shi
Country
Japan
Facility Name
Research Site
City
Itami-shi
Country
Japan
Facility Name
Research Site
City
Izumisano-shi
Country
Japan
Facility Name
Research Site
City
Izumo-shi
Country
Japan
Facility Name
Research Site
City
Kaga-shi
Country
Japan
Facility Name
Research Site
City
Kagoshima-shi
Country
Japan
Facility Name
Research Site
City
Kakegawa-shi
Country
Japan
Facility Name
Research Site
City
Kamakura-shi
Country
Japan
Facility Name
Research Site
City
Kashiwazaki-shi
Country
Japan
Facility Name
Research Site
City
Kasuga-shi
Country
Japan
Facility Name
Research Site
City
Kawasaki-shi
Country
Japan
Facility Name
Research Site
City
Kobe-shi
Country
Japan
Facility Name
Research Site
City
Kochi-shi
Country
Japan
Facility Name
Research Site
City
Koga-shi
Country
Japan
Facility Name
Research Site
City
Komatsu-shi
Country
Japan
Facility Name
Research Site
City
Komoro-shi
Country
Japan
Facility Name
Research Site
City
Koshigaya-shi
Country
Japan
Facility Name
Research Site
City
Kumamoto-shi
Country
Japan
Facility Name
Research Site
City
Kure-shi
Country
Japan
Facility Name
Research Site
City
Kurume-shi
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
Country
Japan
Facility Name
Research Site
City
Maizuru-shi
Country
Japan
Facility Name
Research Site
City
Marugame-shi
Country
Japan
Facility Name
Research Site
City
Matsudo-shi
Country
Japan
Facility Name
Research Site
City
Matsuyama-shi
Country
Japan
Facility Name
Research Site
City
Nagano-shi
Country
Japan
Facility Name
Research Site
City
Nagasaki-shi
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
Country
Japan
Facility Name
Research Site
City
Nakano-ku
Country
Japan
Facility Name
Research Site
City
Nakano-shi
Country
Japan
Facility Name
Research Site
City
Narita-shi
Country
Japan
Facility Name
Research Site
City
Nihonmatsu-shi
Country
Japan
Facility Name
Research Site
City
Okayama-shi
Country
Japan
Facility Name
Research Site
City
Okinawa-shi
Country
Japan
Facility Name
Research Site
City
Onga-gun
Country
Japan
Facility Name
Research Site
City
Ookawa-shi
Country
Japan
Facility Name
Research Site
City
Osaka-shi
Country
Japan
Facility Name
Research Site
City
Saga-shi
Country
Japan
Facility Name
Research Site
City
Sagamihara-shi
Country
Japan
Facility Name
Research Site
City
Saijo-shi
Country
Japan
Facility Name
Research Site
City
Sakai-shi
Country
Japan
Facility Name
Research Site
City
Sanuki-shi
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
Country
Japan
Facility Name
Research Site
City
Sayama-shi
Country
Japan
Facility Name
Research Site
City
Sendai-shi
Country
Japan
Facility Name
Research Site
City
Shiroishi-shi
Country
Japan
Facility Name
Research Site
City
Shizuoka-shi
Country
Japan
Facility Name
Research Site
City
Suita-shi
Country
Japan
Facility Name
Research Site
City
Suwa-shi
Country
Japan
Facility Name
Research Site
City
Tachikawa-shi
Country
Japan
Facility Name
Research Site
City
Takasaki-shi
Country
Japan
Facility Name
Research Site
City
Takayama-shi
Country
Japan
Facility Name
Research Site
City
Tokushima-shi
Country
Japan
Facility Name
Research Site
City
Toyama-shi
Country
Japan
Facility Name
Research Site
City
Toyohashi-shi
Country
Japan
Facility Name
Research Site
City
Toyota-shi
Country
Japan
Facility Name
Research Site
City
Tsu-shi
Country
Japan
Facility Name
Research Site
City
Ube-shi
Country
Japan
Facility Name
Research Site
City
Ueda-shi
Country
Japan
Facility Name
Research Site
City
Uji-shi
Country
Japan
Facility Name
Research Site
City
Ureshino-shi
Country
Japan
Facility Name
Research Site
City
Utsunomiya-shi
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
Country
Japan
Facility Name
Research Site
City
Zentsuji-shi
Country
Japan
Facility Name
Research Site
City
Busan
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
Country
Korea, Republic of
Facility Name
Research Site
City
Gwangju
Country
Korea, Republic of
Facility Name
Research Site
City
Incheon
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Wonju-si
Country
Korea, Republic of
Facility Name
Research Site
City
Aguascalientes
Country
Mexico
Facility Name
Research Site
City
Culiacan
Country
Mexico
Facility Name
Research Site
City
D.F
Country
Mexico
Facility Name
Research Site
City
Del. Cuauhtemoc
Country
Mexico
Facility Name
Research Site
City
Distrito Federal
Country
Mexico
Facility Name
Research Site
City
Monterrey
Country
Mexico
Facility Name
Research Site
City
Bellavista
Country
Peru
Facility Name
Research Site
City
Callao
Country
Peru
Facility Name
Research Site
City
Cusco
Country
Peru
Facility Name
Research Site
City
Lima
Country
Peru
Facility Name
Research Site
City
Baguio City
Country
Philippines
Facility Name
Research Site
City
Cagayan de Oro City
Country
Philippines
Facility Name
Research Site
City
Cebu
Country
Philippines
Facility Name
Research Site
City
Iloilo City
Country
Philippines
Facility Name
Research Site
City
Manila
Country
Philippines
Facility Name
Research Site
City
Pasay City
Country
Philippines
Facility Name
Research Site
City
Pasig City
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Białystok
Country
Poland
Facility Name
Research Site
City
Chełm
Country
Poland
Facility Name
Research Site
City
Działdowo
Country
Poland
Facility Name
Research Site
City
Gdańsk
Country
Poland
Facility Name
Research Site
City
Gryfice
Country
Poland
Facility Name
Research Site
City
Katowice
Country
Poland
Facility Name
Research Site
City
Kielce
Country
Poland
Facility Name
Research Site
City
Końskie
Country
Poland
Facility Name
Research Site
City
Kraków
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Olsztyn
Country
Poland
Facility Name
Research Site
City
Ostrołęka
Country
Poland
Facility Name
Research Site
City
Sandomierz
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Włocławek
Country
Poland
Facility Name
Research Site
City
Łódź
Country
Poland
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Oradea
Country
Romania
Facility Name
Research Site
City
Sibiu
Country
Romania
Facility Name
Research Site
City
Timisoara
Country
Romania
Facility Name
Research Site
City
Tirgu-Mures
Country
Romania
Facility Name
Research Site
City
Belgorod
Country
Russian Federation
Facility Name
Research Site
City
Chelyabinsk
Country
Russian Federation
Facility Name
Research Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
Research Site
City
Irkutsk
Country
Russian Federation
Facility Name
Research Site
City
Izhevsk
Country
Russian Federation
Facility Name
Research Site
City
Kazan
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Nizhnii Novgorod
Country
Russian Federation
Facility Name
Research Site
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Research Site
City
Omsk
Country
Russian Federation
Facility Name
Research Site
City
Perm
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Saratov
Country
Russian Federation
Facility Name
Research Site
City
Ufa
Country
Russian Federation
Facility Name
Research Site
City
Voronezh
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Research Site
City
Levoca
Country
Slovakia
Facility Name
Research Site
City
Martin
Country
Slovakia
Facility Name
Research Site
City
Nitra
Country
Slovakia
Facility Name
Research Site
City
Spisska Nova Ves
Country
Slovakia
Facility Name
Research Site
City
Trnava
Country
Slovakia
Facility Name
Research Site
City
Zilina
Country
Slovakia
Facility Name
Research Site
City
Albacete
Country
Spain
Facility Name
Research Site
City
Badalona(Barcelona)
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Gerona
Country
Spain
Facility Name
Research Site
City
Lleida
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Pamplona
Country
Spain
Facility Name
Research Site
City
Santiago(A Coruña)
Country
Spain
Facility Name
Research Site
City
Sevilla
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Valladolid
Country
Spain
Facility Name
Research Site
City
Falun
Country
Sweden
Facility Name
Research Site
City
Göteborg
Country
Sweden
Facility Name
Research Site
City
Halmstad
Country
Sweden
Facility Name
Research Site
City
Karlstad
Country
Sweden
Facility Name
Research Site
City
Lidköping
Country
Sweden
Facility Name
Research Site
City
Linköping
Country
Sweden
Facility Name
Research Site
City
Malmö
Country
Sweden
Facility Name
Research Site
City
Mora
Country
Sweden
Facility Name
Research Site
City
Norrköping
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden
Facility Name
Research Site
City
Västerås
Country
Sweden
Facility Name
Research Site
City
Östersund
Country
Sweden
Facility Name
Research Site
City
Aarau
Country
Switzerland
Facility Name
Research Site
City
Basel
Country
Switzerland
Facility Name
Research Site
City
Bern
Country
Switzerland
Facility Name
Research Site
City
Chur
Country
Switzerland
Facility Name
Research Site
City
Genève 14
Country
Switzerland
Facility Name
Research Site
City
Lausanne
Country
Switzerland
Facility Name
Research Site
City
Lugano
Country
Switzerland
Facility Name
Research Site
City
St. Gallen
Country
Switzerland
Facility Name
Research Site
City
Villars-sur-Glâne
Country
Switzerland
Facility Name
Research Site
City
Zürich
Country
Switzerland
Facility Name
Research Site
City
Changhua City
Country
Taiwan
Facility Name
Research Site
City
Chiayi
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
Country
Taiwan
Facility Name
Research Site
City
New Taipei
Country
Taiwan
Facility Name
Research Site
City
Taichung
Country
Taiwan
Facility Name
Research Site
City
Tainan
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Taoyuan Hsien
Country
Taiwan
Facility Name
Research Site
City
Bangkok
Country
Thailand
Facility Name
Research Site
City
Chonburi
Country
Thailand
Facility Name
Research Site
City
Khon Kaen
Country
Thailand
Facility Name
Research Site
City
Muang
Country
Thailand
Facility Name
Research Site
City
Patumthani
Country
Thailand
Facility Name
Research Site
City
Rajthevi
Country
Thailand
Facility Name
Research Site
City
Ratchathewi
Country
Thailand
Facility Name
Research Site
City
Ankara
Country
Turkey
Facility Name
Research Site
City
Antalya
Country
Turkey
Facility Name
Research Site
City
Eskisehir
Country
Turkey
Facility Name
Research Site
City
Istanbul
Country
Turkey
Facility Name
Research Site
City
Izmir
Country
Turkey
Facility Name
Research Site
City
Konya
Country
Turkey
Facility Name
Research Site
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Lutsk
Country
Ukraine
Facility Name
Research Site
City
Lviv
Country
Ukraine
Facility Name
Research Site
City
Uzhgorod
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhya
Country
Ukraine
Facility Name
Research Site
City
Hanoi
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh City
Country
Vietnam
Facility Name
Research Site
City
Hochiminh
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
35538232
Citation
Diener HC, Easton JD, Hart RG, Kasner S, Kamel H, Ntaios G. Review and update of the concept of embolic stroke of undetermined source. Nat Rev Neurol. 2022 Aug;18(8):455-465. doi: 10.1038/s41582-022-00663-4. Epub 2022 May 10.
Results Reference
derived
PubMed Identifier
32666831
Citation
Evans SR, Knutsson M, Amarenco P, Albers GW, Bath PM, Denison H, Ladenvall P, Jonasson J, Easton JD, Minematsu K, Molina CA, Wang Y, Wong KL, Johnston SC. Methodologies for pragmatic and efficient assessment of benefits and harms: Application to the SOCRATES trial. Clin Trials. 2020 Dec;17(6):617-626. doi: 10.1177/1740774520941441. Epub 2020 Jul 15.
Results Reference
derived
PubMed Identifier
31296654
Citation
Cucchiara B, George DK, Kasner SE, Knutsson M, Denison H, Ladenvall P, Amarenco P, Johnston SC. Disability after minor stroke and TIA: A secondary analysis of the SOCRATES trial. Neurology. 2019 Aug 13;93(7):e708-e716. doi: 10.1212/WNL.0000000000007936. Epub 2019 Jul 11.
Results Reference
derived
PubMed Identifier
31092152
Citation
Easton JD, Denison H, Evans SR, Knutsson M, Amarenco P, Albers GW, Ladenvall P, Minematsu K, Molina CA, Wang Y, Wong KL, Johnston SC; SOCRATES Steering Committee and Investigators. Estimated treatment effect of ticagrelor versus aspirin by investigator-assessed events compared with judgement by an independent event adjudication committee in the SOCRATES trial. Int J Stroke. 2019 Dec;14(9):908-914. doi: 10.1177/1747493019851282. Epub 2019 May 15.
Results Reference
derived
PubMed Identifier
30776996
Citation
Molina CA, Johnston SC, Ladenvall P, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Knutsson M, Minematsu K, Rother J, Wang Y, Wong KSL; SOCRATES Steering Committee and Investigators. Time to Loading Dose and Risk of Recurrent Events in the SOCRATES Trial. Stroke. 2019 Mar;50(3):675-682. doi: 10.1161/STROKEAHA.118.022675. Erratum In: Stroke. 2019 Apr;50(4):e118.
Results Reference
derived
PubMed Identifier
29915123
Citation
Wong KSL, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Himmelmann A, Kasner SE, Knutsson M, Ladenvall P, Minematsu K, Molina CA, Wang Y, Johnston SC; SOCRATES Steering Committee and Investigators. Efficacy and Safety of Ticagrelor in Relation to Aspirin Use Within the Week Before Randomization in the SOCRATES Trial. Stroke. 2018 Jul;49(7):1678-1685. doi: 10.1161/STROKEAHA.118.020553. Epub 2018 Jun 18.
Results Reference
derived
PubMed Identifier
28720658
Citation
Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Hill MD, Jonasson J, Kasner SE, Ladenvall P, Minematsu K, Molina CA, Wang Y, Wong KSL, Johnston SC; SOCRATES Steering Committee and Investigators. Ticagrelor Versus Aspirin in Acute Embolic Stroke of Undetermined Source. Stroke. 2017 Sep;48(9):2480-2487. doi: 10.1161/STROKEAHA.117.017217. Epub 2017 Jul 18.
Results Reference
derived
PubMed Identifier
28655834
Citation
Easton JD, Aunes M, Albers GW, Amarenco P, Bokelund-Singh S, Denison H, Evans SR, Held P, Jahreskog M, Jonasson J, Minematsu K, Molina CA, Wang Y, Wong KSL, Johnston SC; SOCRATES Steering Committee and Investigators. Risk for Major Bleeding in Patients Receiving Ticagrelor Compared With Aspirin After Transient Ischemic Attack or Acute Ischemic Stroke in the SOCRATES Study (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes). Circulation. 2017 Sep 5;136(10):907-916. doi: 10.1161/CIRCULATIONAHA.117.028566. Epub 2017 Jun 27.
Results Reference
derived
PubMed Identifier
28238711
Citation
Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Hill MD, Jonasson J, Kasner SE, Ladenvall P, Minematsu K, Molina CA, Wang Y, Wong KSL, Johnston SC; SOCRATES Steering Committee and Investigators. Efficacy and safety of ticagrelor versus aspirin in acute stroke or transient ischaemic attack of atherosclerotic origin: a subgroup analysis of SOCRATES, a randomised, double-blind, controlled trial. Lancet Neurol. 2017 Apr;16(4):301-310. doi: 10.1016/S1474-4422(17)30038-8. Epub 2017 Feb 23.
Results Reference
derived
PubMed Identifier
27899747
Citation
Wang Y, Minematsu K, Wong KS, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Jonasson J, Molina CA, Johnston SC; SOCRATES Steering Committee and Investigators. Ticagrelor in Acute Stroke or Transient Ischemic Attack in Asian Patients: From the SOCRATES Trial (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes). Stroke. 2017 Jan;48(1):167-173. doi: 10.1161/STROKEAHA.116.014891. Epub 2016 Nov 29.
Results Reference
derived
PubMed Identifier
27160944
Citation
Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.
Results Reference
derived
PubMed Identifier
27160892
Citation
Johnston SC, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Jonasson J, Minematsu K, Molina CA, Wang Y, Wong KS; SOCRATES Steering Committee and Investigators. Ticagrelor versus Aspirin in Acute Stroke or Transient Ischemic Attack. N Engl J Med. 2016 Jul 7;375(1):35-43. doi: 10.1056/NEJMoa1603060. Epub 2016 May 10.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1836&filename=d5134c00001-revised-csp-2-redacted_1July2015.pdf
Description
CSP

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[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]

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