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Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting

Primary Purpose

Carotid Stenosis

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Carotid stenting
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Ischemis stroke of both sex.
  2. More than 18 years.
  3. Accepting all study requirements.

Exclusion Criteria:

  1. Refuse to comply with all study requirements.
  2. bleeding tendency or liver diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    aspirin + ticagrelor before carotid stenting

    aspirin + clopidogrel before carotid stenting

    Arm Description

    patients undergoing carotid stenting take aspirin 150 mg + ticagrelor 90mg for 15 days before carotid stenting

    patients undergoing carotid stenting take aspirin 150 mg + clopidogrel 75 mg for 15 days before carotid stenting

    Outcomes

    Primary Outcome Measures

    compare efficacy of ticagrelor and clopidogrel in patients undergoing carotid stenting
    patients undergoing carotid stenting are divided into 2 groups comparing efficacy of ticagrelor and clopidogrel
    Compare safety of ticagrelor and clopidogrel in patients undergoing carotid stenting
    Patients undergoing carotid stenting are divided into two groups comparing safety of ticagrelor and clopidogrel

    Secondary Outcome Measures

    Pattern of carotid stenosis
    Incidence of carotid stenosis in patients come to Assiut university hospitals

    Full Information

    First Posted
    September 12, 2019
    Last Updated
    March 22, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04091074
    Brief Title
    Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting
    Official Title
    Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    patients undergoing carotid stenting take dual anti platelet therapy to prevent thrombotic complications usually used drugs are aspirin plus clopidogrel but there are patients not respond so ticagrelor may be an effective and safe alternative

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carotid Stenosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    26 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    aspirin + ticagrelor before carotid stenting
    Arm Type
    Active Comparator
    Arm Description
    patients undergoing carotid stenting take aspirin 150 mg + ticagrelor 90mg for 15 days before carotid stenting
    Arm Title
    aspirin + clopidogrel before carotid stenting
    Arm Type
    Active Comparator
    Arm Description
    patients undergoing carotid stenting take aspirin 150 mg + clopidogrel 75 mg for 15 days before carotid stenting
    Intervention Type
    Drug
    Intervention Name(s)
    Ticagrelor
    Intervention Description
    Half of patients undergoing carotid stenting take ticagrelor+aspirin
    Intervention Type
    Drug
    Intervention Name(s)
    Clopidogrel
    Intervention Description
    Other half ofpatients undergoing carotid stenting take clopidogrel+aspirin
    Intervention Type
    Procedure
    Intervention Name(s)
    Carotid stenting
    Intervention Description
    Patients with carotid stenosis will undergo carotid stenting
    Primary Outcome Measure Information:
    Title
    compare efficacy of ticagrelor and clopidogrel in patients undergoing carotid stenting
    Description
    patients undergoing carotid stenting are divided into 2 groups comparing efficacy of ticagrelor and clopidogrel
    Time Frame
    15 days before carotid stenting
    Title
    Compare safety of ticagrelor and clopidogrel in patients undergoing carotid stenting
    Description
    Patients undergoing carotid stenting are divided into two groups comparing safety of ticagrelor and clopidogrel
    Time Frame
    15 days before carotid stenting
    Secondary Outcome Measure Information:
    Title
    Pattern of carotid stenosis
    Description
    Incidence of carotid stenosis in patients come to Assiut university hospitals
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Ischemis stroke of both sex. More than 18 years. Accepting all study requirements. Exclusion Criteria: Refuse to comply with all study requirements. bleeding tendency or liver diseases

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting

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