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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
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
June 27, 2021
Last Updated
July 4, 2021
Sponsor
Peking University Third Hospital
Collaborators
AstraZeneca Investment (China) Co., Ltd
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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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