Study identifier:D5134C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2012-003895-38
CTIS identifier:N/A
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.
Acute Ischaemic Stroke, Transient ischaemic attack
Phase 3
No
ticagrelor, Acetylsalicylic acid (ASA)
All
13307
Interventional
40 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verified 01 May 2017 by AstraZeneca
AstraZeneca
-
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).
Location
Location
Capital Federal, Argentina
Location
Leuven, Belgium
Location
GENT, Belgium
Location
Brussels (Woluwé-St-Lambert), Belgium
Location
Tielt, Belgium
Location
Assebroek, Belgium
Location
Godinne, Belgium
Location
Wilrijk, Belgium
Arms | Assigned Interventions |
---|---|
Experimental: ticagrelor | Drug: ticagrelor ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily. |
Active Comparator: Acetylsalicylic acid (ASA) | Drug: Acetylsalicylic acid (ASA) ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily. |
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