Phase 3 N=13,199 Randomized Double-blind Prevention

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

Acute Ischaemic Stroke · Transient Ischaemic Attack

Bottom Line

View on ClinicalTrials.gov: NCT01994720 ↗

Enrolled (actual)

13,199

Serious AEs

8.1%

Results posted

Jun 2017

Primary outcome: Primary: Number of Participants With Composite of Stroke/MI/Death — 442; 497 Participants — p=0.0670

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ticagrelor (Drug); Acetylsalicylic acid (ASA) (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Mar 2016

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

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).

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01994720). 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.