Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting

March 22, 2021 updated by: Osama Ibrahim Aboelfath Ibrahim, Assiut University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Phase 1

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: aspirin + ticagrelor before carotid stenting
patients undergoing carotid stenting take aspirin 150 mg + ticagrelor 90mg for 15 days before carotid stenting
Drug: Ticagrelor
Half of patients undergoing carotid stenting take ticagrelor+aspirin
Procedure: Carotid stenting
Patients with carotid stenosis will undergo carotid stenting
ACTIVE_COMPARATOR: aspirin + clopidogrel before carotid stenting
patients undergoing carotid stenting take aspirin 150 mg + clopidogrel 75 mg for 15 days before carotid stenting
Procedure: Carotid stenting
Patients with carotid stenosis will undergo carotid stenting
Drug: Clopidogrel
Other half ofpatients undergoing carotid stenting take clopidogrel+aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare efficacy of ticagrelor and clopidogrel in patients undergoing carotid stenting
Time Frame: 15 days before carotid stenting
patients undergoing carotid stenting are divided into 2 groups comparing efficacy of ticagrelor and clopidogrel
15 days before carotid stenting
Compare safety of ticagrelor and clopidogrel in patients undergoing carotid stenting
Time Frame: 15 days before carotid stenting
Patients undergoing carotid stenting are divided into two groups comparing safety of ticagrelor and clopidogrel
15 days before carotid stenting

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of carotid stenosis
Time Frame: 1 year
Incidence of carotid stenosis in patients come to Assiut university hospitals
1 year

Collaborators and Investigators

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

Sponsor

Assiut University

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 (ANTICIPATED)

January 1, 2022

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

September 12, 2019

First Submitted That Met QC Criteria

September 13, 2019

First Posted (ACTUAL)

September 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ticagrelor in carotid stenting

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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