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

Peking University

Status and phase: Completed; Phase 4

Conditions: Cerebrovascular Accident; Cerebrovascular Accident, Acute

Treatments: Drug: Placebo+ASA; Drug: ticagrelor + ASA

Study type: Interventional

Funder types: Other

Identifiers

NCT04962451

D2017121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13,000 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

13,000 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Treatment:

Drug: ticagrelor + ASA

Placebo group

Placebo Comparator group

Treatment:

Drug: Placebo+ASA