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

NCT01994720 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13307

Last updated 2017-06-12

Study results available
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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).

Conditions

  • Acute Ischaemic Stroke
  • Transient Ischaemic Attack

Interventions

DRUG

ticagrelor

ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily.

DRUG

Acetylsalicylic acid (ASA)

ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-07
Primary Completion
2016-03-02
Completion
2016-03-02

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Japan
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • Vietnam

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01994720 on ClinicalTrials.gov