Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Acute Ischemic STROKE（PATH-STROKE） (PATH-STROKE)

February 20, 2024 updated by: Jie Yang, Sichuan Provincial People's Hospital

Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Acute Ischemic STROKE

Objectives of Study:To explore the efficacy and safety of antiplatelet therapy in patients with non-cardiogenic cerebral infarction under the guidance of platelet aggregation function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Non cardiogenic cerebral infarction accounts for more than 50% of cerebral infarction, and the key to its onset is an increase in platelet aggregation function. Aspirin is an IA recommended drug for the prevention and treatment of non cardiogenic cerebral infarction. However, after taking aspirin and clopidogrel regularly, more than 30% of stroke patients still experience ischemic events (aspirin resistance, clopidogrel resistance), leading to stroke recurrence. Aspirin is the main antiplatelet drug for the prevention and treatment of non cardiogenic cerebral infarction. Therefore, clinical research on aspirin resistance in the prevention and treatment of non cardiogenic cerebral infarction is of great significance, which can help partially solve the bottleneck of antiplatelet therapy resistance in cerebral infarction. Platelet aggregation function testing can timely detect resistance to antiplatelet therapy, guide drug adjustments, and researchers will compare the experimental group (receiving precise antiplatelet therapy) with the control group (blindly taking aspirin) to see if the experimental group will reduce stroke recurrence or mortality, in order to prevent and treat cerebral infarction with aspirin and clopidogrel resistance and reduce the recurrence rate of cerebral infarction.

Study Type

Interventional

Enrollment (Estimated)

3524

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged from 18 to 80 years;
  2. Patients with non-cardiogenic cerebral infarction WHO meet the definition of stroke, who have been ruled out hemorrhagic stroke by head CT or MRI examination and identified as ischemic stroke;
  3. The onset of first stroke >=1 month;
  4. mRS Score <=2 points;
  5. Mab platelet therapy with aspirin 100mg qd for >=14 days;
  6. Informed consent signed by the patient or legal representative.

Exclusion Criteria:

  1. History of gastrointestinal bleeding, intracranial bleeding, and other hemorrhagic diseases;
  2. Contraindications or intolerances to the use of antiplatelet therapy drugs;
  3. Patients with severe heart, lung, liver and renal insufficiency and with serious co-existing diseases (such as tumor, chronic airflow disease, severe dementia, and severe heart failure;
  4. Poor compliance, unable to cooperate with the completion of research requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Precision Antiplatelet Therapy Trial Group
Platelet function testing guides antiplatelet drug selection
Drug: Precision Antiplatelet Therapy Trial Group
Use SPCM method to detect platelet aggregation function in patients, adjust antiplatelet drugs based on the test results, and receive precise antiplatelet treatment for 12 months. Non resistant patients with aspirin will continue to receive aspirin 100mg qd; Patients with aspirin resistance were given clopidogrel 75mg qd; Clopidogrel resistant patients were given ticagrelor 90mg bid.
Active Comparator: Traditional Antiplatelet Therapy Control Group
Aspirin 100mg orally once a day
Drug: Traditional Antiplatelet Therapy Control Group
No adjustment of antiplatelet medication is required, and routine treatment with aspirin 100mg qd is given for 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-month major ischemic events and major bleeding events
Time Frame: 3-month
Including any of the following: Cardiovascular and cerebrovascular mortality, Incidence of stroke (including ischemic and hemorrhagic), Incidence of myocardial infarction, bleeding events classified by BARC (Bleeding Academic Research Consortium) criteria
3-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disability
Time Frame: 3-month
mRS(Modified Rankin Scale)>2
3-month
Cardiovascular or cerebrovascular mortality
Time Frame: 3-month
mortality of Cardiovascular or cerebrovascular disease
3-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Provincial People's Hospital

Investigators

  • Study Chair: Jie Yang, doctor, Sichuan Provincial People's Hospital
  • Study Chair: YaPeng Lin, First Affiliated Hospital of Chengdu Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Estimated)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023YFS0042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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