Pair Antiplatelet THerapy in Ischemic Stroke With Intracranial Artery Stenosis (PATH-ICAS)

June 17, 2024 updated by: Nengwei Yu, Sichuan Provincial People's Hospital

The goal of this clinical trial is to learn about efficacy and safety of dual antiplatelet therapy in ischemic stroke with intracranial artery stenosis. The main question it aims to answer are:

whether aspirin combined with clopidogrel for 3 month is better than 1 months for patients with non-cardiogenic cerebral infarction with intracranial artery stenosis.

Participants will get dual antiplatelet therapy (aspirin plus clopidogrel) for 1 month or 3 months within 7 days of the first stroke.

Researchers will compare experimental group (3 months dual antiplatelet therapy) with comparison group (1 month dual antiplatelet therapy), to see if experimental group would reduce stroke recurrence or mortality, and increase bleeding and other adverse prognosis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1100

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
        • 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. Age 40 ~ 80 years old;
  2. Patients diagnosed as non-cardiogenic cerebral infarction according to the WHO definition of stroke, with MRA/CTA/DSA confirmed intracranial artery stenosis ≥50% (intracranial carotid artery, M1 and proximal M2 segment of middle cerebral artery, A1 and A2 segment of anterior cerebral artery, P1 and P2 segment of posterior cerebral artery, intracranial vertebral artery and basilar artery);
  3. First stroke onset within 7 days;
  4. NIHSS score ≤5;
  5. Patients or family members sign informed consent forms;

Exclusion Criteria:

  1. Patients receiving thrombolysis or endovascular therapy;
  2. Patients with recurrent stroke;
  3. Patients has undergone major surgery or major trauma within the past 30 days;
  4. History of gastrointestinal bleeding, active peptic ulcer, intracranial hemorrhage or other hemorrhagic diseases;
  5. Contraindications or intolerances to the use of antiplatelet therapeutics;
  6. Platelet count <100*109/L, hemoglobin<110g/L;
  7. Patients with severe organ insufficiency or other serious disease (e.g., severe cardiopulmonary failure, advanced tumor, severe dementia);
  8. Patients intolerant to MRI scan are replaced by CT or DSA;
  9. poor compliance, unable to meet the requirements of the study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dual antiplatelet therapy for 30 days
Clopidogrel 300mg on the first day, then 75mg/ day for 30 consecutive days; Aspirin 100mg/ day for 90 days
Drug: clopidogrel for 30 days combined with aspirin for 90 days
Clopidogrel 300mg on the first day, then 75mg/ day for 30 consecutive days; Aspirin 100mg/ day for 90 days
Active Comparator: Dual antiplatelet therapy for 90 days
Clopidogrel 300mg on the first day, then 75mg/day for 90 consecutive days; Aspirin 100mg/day for 90 days
Drug: clopidogrel for 90 days combined with aspirin for 90 days
Clopidogrel 300mg on the first day, then 75mg/day for 90 consecutive days; Aspirin 100mg/day for 90 days

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: Nengwei Yu, master, Sichuan Provincial People's Hospital
  • Study Chair: Jie Yang, doctor, Sichuan Provincial People's Hospital

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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

January 28, 2024

First Submitted That Met QC Criteria

January 28, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20223972

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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