Clinical trial NCT04962451: Comparison of the Efficacy of Ticagrelor Combined With ASA to ASA Alone in Patients With Stroke
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebrovascular Accident
Cerebrovascular Accident, Acute
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2021-07-15
Enrollment: 13000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Over 40 years old
2. Acute ischemic attack
3. Symptoms occurred within 24 hours after randomization

Exclusion Criteria:

1. Dual antiplatelet therapy with ASA and P2Y12 inhibitors is needed
2. Antiplatelet agents other than ASA
3. Anticoagulant therapy
4. Have any atrial fibrillation / flutter
5. Renal failure requiring dialysis
6. During pregnancy or lactation

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: At day 7 after participants included into the research
measure: Occurrence of adverse events
timeFrame: At day 30 after participants included into the research
measure: Occurrence of adverse events
timeFrame: At day 60 after participants included into the research
Secondary outcomes:
measure: Tool assessment result
timeFrame: At day 60 after participants included into the research
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Xiaogang Li
role: PRINCIPAL_INVESTIGATOR
References: