Phase 3
Completed N=13,199
[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]
Source: ClinicalTrials.gov NCT01994720 ↗Enrolled (actual)
13,199
Serious AEs
8.1%
Results posted
Jun 2017
Primary outcomePrimary: Number of Participants With Composite of Stroke/MI/Death — 442; 497 Participants — p=0.0670
◆ Published Evidence
Highly cited
106citations · ~27 / year
Review and update of the concept of embolic stroke of undetermined source.
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).
Linked Publications (5)
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Review and update of the concept of embolic stroke of undetermined source.
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Disability after minor stroke and TIA: A secondary analysis of the SOCRATES trial.
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Methodologies for pragmatic and efficient assessment of benefits and harms: Application to the SOCRATES trial.
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Estimated treatment effect of ticagrelor versus aspirin by investigator-assessed events compared with judgement by an independent event adjudication committee in the SOCRATES trial.
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Time to Loading Dose and Risk of Recurrent Events in the SOCRATES Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Composite of Stroke/MI/Death |
442; 497 | 0.0670 |
| SECONDARY Number of Participants With Ischaemic Stroke |
385; 441 | 0.0462 sig |
| SECONDARY Net Clinical Outcome |
457; 508 | 0.0928 |
| SECONDARY Number of Participants With Composite of Ischaemic Stroke, MI and CV Death |
423; 475 | 0.0771 |
| SECONDARY Number of Participants With All-Cause Death |
68; 58 | 0.3641 |
| SECONDARY Number of Participants With CV Death |
41; 35 | 0.4828 |
| SECONDARY Number of Participants With MI |
25; 21 | 0.5457 |
| SECONDARY Number of Participants by Severity of Stroke and Overall Disability |
1107; 1194 | 0.1393 |
| SECONDARY Number of Participants With Stroke |
390; 450 | 0.0342 sig |
| SECONDARY Number of Participants With Fatal Stroke |
18; 17 | 0.8557 |
| SECONDARY Number of Participants With Disabling Stroke |
277; 307 | 0.2126 |
| SECONDARY Change in NIHSS |
132; 127; 403; 438; 779; 810 | — |
| SECONDARY EQ-5D at Visit 1 (Enrolment) |
0.70; 0.70 | — |
| SECONDARY EQ-5D at Visit 2 (Day 7+-2d) |
0.80; 0.79 | — |
| SECONDARY EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit |
0.85; 0.84 | — |
| SECONDARY EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit |
0.72; 0.68 | — |
| SECONDARY Number of Participants With PLATO Major Bleeding Event |
31; 38 | 0.4511 |
| SECONDARY Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event |
82; 37 | <0.0001 sig |
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.
Data sourced from ClinicalTrials.gov (NCT01994720) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.