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

Phase 4

Completed

• Conditions: Cerebrovascular Accident, Acute; Cerebrovascular Accident
• Interventions: Drug: ticagrelor + ASA; Drug: Placebo+ASA

• Registration Number: NCT04962451
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-10-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-07-04
• Last Update Submitted: 2021-07-04
• Study First Posted: 2021-07-15
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13000

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	ticagrelor + ASA	-
Placebo group	Placebo+ASA	-

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events	At day 60 after participants included into the research	The event that patients have stroke or die

Secondary Outcome Measures

Name	Time	Method
Tool assessment result	At day 60 after participants included into the research	Score of Modified Rankin Scale

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China