Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04091074
• Collaborator: (none)
• Enrollment: 26
• Arms: 2
• Anticipated Duration (Months): 11

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Carotid Stenosis	Drug: Ticagrelor; Drug: Clopidogrel; Procedure: Carotid stenting	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting
• Anticipated Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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	Drug: Clopidogrel; Other half ofpatients undergoing carotid stenting take clopidogrel+aspirin; Procedure: Carotid stenting; Patients with carotid stenosis will undergo carotid stenting

Outcome Measures

Primary Outcome Measures

1. compare efficacy of ticagrelor and clopidogrel in patients undergoing carotid stenting [15 days before carotid stenting]

   patients undergoing carotid stenting are divided into 2 groups comparing efficacy of ticagrelor and clopidogrel

2. Compare safety of ticagrelor and clopidogrel in patients undergoing carotid stenting [15 days before carotid stenting]

   Patients undergoing carotid stenting are divided into two groups comparing safety of ticagrelor and clopidogrel

Secondary Outcome Measures

1. Pattern of carotid stenosis [1 year]

   Incidence of carotid stenosis in patients come to Assiut university hospitals

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Osama Ibrahim Aboelfath Ibrahim, Osama Ibrahim Aboelfath Ibrahim, Assiut University
• ClinicalTrials.gov Identifier: NCT04091074
• Other Study ID Numbers: Ticagrelor in carotid stenting
• First Posted: Sep 16, 2019
• Last Update Posted: Mar 23, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carotid Stenosis; Clopidogrel; Ticagrelor

Study Results

No Results Posted as of Mar 23, 2021