CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 13,307 enrolled
Drug / intervention
ticagrelor +1 moredrug
Likely dose
ticagrelor 180 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01994720
NCT01994720Phase 3Completed
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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.

AstraZeneca·interventional·Posted Nov 26, 2013·Updated Jun 12, 2017

In Brief

A Phase 3 clinical trial evaluating ticagrelor and Acetylsalicylic acid (ASA) for Acute Ischaemic Stroke and Transient Ischaemic Attack. Completed, enrolled 13,307 participants across 521 sites in 33 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Ischaemic Stroke, Transient Ischaemic Attack
CountriesArgentina, 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, United States, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 26, 2013
Enrollment StartJan 7, 2014
Primary CompletionMar 2, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.6 years ago

Interventions

ticagrelordrug

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

Acetylsalicylic acid (ASA)drug

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