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Completed

NCT Number: NCT04962451

Comparison of the Efficacy of Ticagrelor Combined With ASA to ASA Alone in Patients With Stroke

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.

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accident, Acute Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University Third Hospital

Beijing, China

About this study

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. The study will be designed as a randomized, double-blind, placebo-controlled, parallel grouping study and conducted in multiple centers to ensure the representation of multiple countries, races and races, so as to ensure that the results of the study can be widely applied.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 40 years old
  • Acute ischemic attack
  • Symptoms occurred within 24 hours after randomization

Exclusion criteria

  • Dual antiplatelet therapy with ASA and P2Y12 inhibitors is needed
  • Antiplatelet agents other than ASA
  • Anticoagulant therapy
  • Have any atrial fibrillation / flutter
  • Renal failure requiring dialysis
  • During pregnancy or lactation

Treatment and study plan

ticagrelor + ASA

Drug

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+ASA

Drug

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

Primary outcomes

  1. Occurrence of adverse events

    Time frame: At day 7 after participants included into the research

    The event that patients have stroke or die

  2. Occurrence of adverse events

    Time frame: At day 30 after participants included into the research

    The event that patients have stroke or die

  3. Occurrence of adverse events

    Time frame: At day 60 after participants included into the research

    The event that patients have stroke or die

Secondary outcomes

  1. Tool assessment result

    Time frame: At day 60 after participants included into the research

    Score of Modified Rankin Scale

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 15, 2021
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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