Efficacy and Safety of Ticagrelor Combined With ASA Versus ASA Alone in Preventing Stroke and Death in Patients With Acute Ischemic Stroke or Transient Ischemic Attack: a Randomized, Double-blind, Placebo-controlled, International Multicenter Phase III Clinical Study
Sponsor study identifier
interventional
13,000
1 country
1
Study Start
September 1, 2017
Actual (reported)Primary Completion
September 30, 2019
Actual (reported)Study Completion
October 31, 2019
Actual (reported)Cerebrovascular disease is the main cause of death and severe long-term disability worldwide. Antiplatelet drugs are the main drugs for ischemic stroke and TIA. Cyclooxygenase inhibitor acetylsalicylic acid (ASA) has always been the most widely studied antiplatelet therapy. The studies of acrates of aliscon body evaluated the efficacy and safety of ticagrelor monotherapy in preventing major vascular events in patients with AIS or TIA. The results showed that the number of patients with endpoint events in ticagrelor group was less than that in ASA group, However, it has not been proved that ticagrelor monotherapy is better than ASA. The purpose of this study is to prove that ticagrelor is better than ASA.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2019
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2017
Actual (reported)September 30, 2019
Actual (reported)October 31, 2019
Actual (reported)June 27, 2021
Actual (reported)July 15, 2021
Actual (reported)Occurrence of adverse events
The event that patients have stroke or die
At day 7 after participants included into the research
Occurrence of adverse events
The event that patients have stroke or die
At day 30 after participants included into the research
Occurrence of adverse events
The event that patients have stroke or die
At day 60 after participants included into the research
Tool assessment result
At day 60 after participants included into the research
On day 1, ticagrelor loading dose (2 tablets, ticagrelor 90mg) was given, followed by ticagrelor 90mg, twice daily Basic treatment: the first day received ASA loading dose, 300-325mg, and the server received ASA 75-100mg, once a day
Placebo loading dose on day 1 (2 tablets, matched with ticagrelor 90mg), followed by placebo twice daily (matched with ticagrelor 90mg) Basic treatment: the first day received ASA loading dose, 300-325mg, and the server received ASA 75-100mg, once a day
Peking University Third Hospital
Beijing, China
Xiaogang Li
Peking University Third Hospital
13,000 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2021
First Posted
July 15, 2021
Study Start
September 1, 2017
Actual (reported)Multi-"Omics" Research of Danhong Injection to Treat Acute Ischemic Stroke
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Primary Completion
September 30, 2019
Actual (reported)Study Completion
October 31, 2019
Actual (reported)Last Updated
July 15, 2021
Record last verified: 2021-06
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Source: ClinicalTrials.gov.
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