Comparison of the Efficacy of Ticagrelor Combined With ASA to ASA Alone in Patients With Stroke
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group
|
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 Comparator: Placebo group
|
Drug: 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
|
Outcome Measures
Primary Outcome Measures
- Occurrence of adverse events [At day 7 after participants included into the research]
The event that patients have stroke or die
- Occurrence of adverse events [At day 30 after participants included into the research]
The event that patients have stroke or die
- Occurrence of adverse events [At day 60 after participants included into the research]
The event that patients have stroke or die
Secondary Outcome Measures
- Tool assessment result [At day 60 after participants included into the research]
Score of Modified Rankin Scale
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University Third Hospital | Beijing | China |
Sponsors and Collaborators
- Peking University Third Hospital
- AstraZeneca Investment (China) Co., Ltd
Investigators
- Principal Investigator: Xiaogang Li, Peking University Third Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D2017121