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

Cerebrovascular Accident Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04962451
• Other study ID #: D2017121
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13000
• Est. completion date: October 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Cerebrovascular Accident, Acute
• Stroke

Intervention

Drug:
• ticagrelor + ASA
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
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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	AstraZeneca Investment (China) Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events	The event that patients have stroke or die	At day 7 after participants included into the research
Primary	Occurrence of adverse events	The event that patients have stroke or die	At day 30 after participants included into the research
Primary	Occurrence of adverse events	The event that patients have stroke or die	At day 60 after participants included into the research
Secondary	Tool assessment result	Score of Modified Rankin Scale	At day 60 after participants included into the research