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Int J Stroke. 2019 Feb 12:1747493019830307. doi: 10.1177/1747493019830307. [Epub ahead of print]

The Acute Stroke or Transient Ischemic Attack Treated with Ticagrelor and Aspirin for Prevention of Stroke and Death (THALES) trial: Rationale and design.

Author information

1
1 Dell Medical School, University of Texas at Austin, Austin, TX, USA.
2
2 Department of Neurology and Stroke Centre, Bichat Hospital, Paris Diderot, Paris, France.
3
3 Global Medicines Development, AstraZeneca, Gothenburg, Sweden.
4
4 Biostatistics Center, George Washington University, Washington DC, MD, USA.
5
5 Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
6
6 Stroke Unit, Hospital Vall d'Hebron, Barcelona, Spain.
7
7 Department of Neurology, Beijing Tiantan Hospital, Beijing, China.

Abstract

RATIONALE:

In patients with acute cerebral ischemia, the rate of stroke, myocardial infarction, or death during 90 days was reported to be non-significantly lower with ticagrelor compared with aspirin, with no increase in major hemorrhage. Dual antiplatelet therapy may be more effective in this setting.

AIM:

To investigate whether ticagrelor combined with aspirin are superior to aspirin alone in preventing stroke or death in patients with non-severe, non-cardioembolic ischemic stroke or high-risk transient ischemic attack.

DESIGN:

The Acute Stroke or Transient Ischemic Attack Treated with Ticagrelor and Aspirin for Prevention of Stroke and Death (THALES) trial is a randomized, placebo-controlled, double-blind, event-driven study. Patients will be randomized within 24 h of onset of acute ischemic symptoms. THALES is expected to randomize 13,000 at ∼450 sites worldwide, to collect 764 primary outcome events. Study treatments are ticagrelor 180 mg loading dose on day 1, then 90 mg twice daily on days 2-30, or matching placebo. All patients will also receive open-label aspirin 300-325 mg on day 1, then 75-100 mg once daily on days 2-30.

STUDY OUTCOMES:

The primary efficacy outcome is time to the composite endpoint of stroke or death through 30-day follow-up. The primary safety outcome is time to first severe bleeding event.

DISCUSSION:

The THALES trial will provide important information about the benefits and risks of dual antiplatelet therapy with ticagrelor and aspirin in patients with acute cerebral ischemia in a global setting (funding: AstraZeneca).

CLINICAL TRIAL REGISTRATION URL:

http://www.clinicaltrials.gov . Unique identifier: NCT03354429.

KEYWORDS:

Stroke; TIA; antiplatelet; aspirin; cerebral ischemia; ticagrelor

PMID:
30747613
DOI:
10.1177/1747493019830307

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