Comparison of the Efficacy of Ticagrelor Combined With ASA to ASA Alone in Patients With Stroke
Primary Purpose
Cerebrovascular Accident, Cerebrovascular Accident, Acute
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
ticagrelor + ASA
Placebo+ASA
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident
Eligibility 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
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention group
Placebo group
Arm Description
Outcomes
Primary Outcome Measures
Occurrence of adverse events
The event that patients have stroke or die
Occurrence of adverse events
The event that patients have stroke or die
Occurrence of adverse events
The event that patients have stroke or die
Secondary Outcome Measures
Tool assessment result
Score of Modified Rankin Scale
Full Information
NCT ID
NCT04962451
First Posted
June 27, 2021
Last Updated
July 4, 2021
Sponsor
Peking University Third Hospital
Collaborators
AstraZeneca Investment (China) Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04962451
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
AstraZeneca Investment (China) Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident, Cerebrovascular Accident, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ticagrelor + ASA
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo+ASA
Intervention Description
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
Primary Outcome Measure Information:
Title
Occurrence of adverse events
Description
The event that patients have stroke or die
Time Frame
At day 7 after participants included into the research
Title
Occurrence of adverse events
Description
The event that patients have stroke or die
Time Frame
At day 30 after participants included into the research
Title
Occurrence of adverse events
Description
The event that patients have stroke or die
Time Frame
At day 60 after participants included into the research
Secondary Outcome Measure Information:
Title
Tool assessment result
Description
Score of Modified Rankin Scale
Time Frame
At day 60 after participants included into the research
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaogang Li
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of the Efficacy of Ticagrelor Combined With ASA to ASA Alone in Patients With Stroke
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