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

NCT04962451 | Completed Phase 4 DMC

• 1 other identifier: D2017121
• Study Type: interventional
• Target: 13,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident; Cerebrovascular Accident, Acute

Outcome Measures

Primary Outcomes (3)

• Occurrence of adverse events

  The event that patients have stroke or die

  At day 7 after participants included into the research

• Occurrence of adverse events

  The event that patients have stroke or die

  At day 30 after participants included into the research

• Occurrence of adverse events

  The event that patients have stroke or die

  At day 60 after participants included into the research

Secondary Outcomes (1)

• Tool assessment result

  At day 60 after participants included into the research

Study Arms (2)

Intervention group

EXPERIMENTAL

Drug: ticagrelor + ASA

Placebo group

PLACEBO COMPARATOR

Drug: Placebo+ASA

Interventions

ticagrelor + ASA DRUG

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 group

Placebo+ASA DRUG

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

Placebo group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 40 years old
• Acute ischemic attack
• Symptoms occurred within 24 hours after randomization

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Stroke

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Xiaogang Li

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 15, 2021
• Study Start: September 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: October 31, 2019
• Last Updated: July 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)