NCT04091074

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed
2.3 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

September 12, 2019

Last Update Submit

March 22, 2021

Conditions

Carotid Stenosis

Outcome Measures

Primary Outcomes (2)

  • 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

    15 days before carotid stenting

  • 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

    15 days before carotid stenting

Secondary Outcomes (1)

  • Pattern of carotid stenosis

    1 year

Study Arms (2)

aspirin + ticagrelor before carotid stenting

ACTIVE COMPARATOR

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

Drug: TicagrelorProcedure: Carotid stenting

aspirin + clopidogrel before carotid stenting

ACTIVE COMPARATOR

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

Drug: ClopidogrelProcedure: Carotid stenting

Interventions

TicagrelorDRUG

Half of patients undergoing carotid stenting take ticagrelor+aspirin

aspirin + ticagrelor before carotid stenting
ClopidogrelDRUG

Other half ofpatients undergoing carotid stenting take clopidogrel+aspirin

aspirin + clopidogrel before carotid stenting
Carotid stentingPROCEDURE

Patients with carotid stenosis will undergo carotid stenting

aspirin + clopidogrel before carotid stentingaspirin + ticagrelor before carotid stenting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemis stroke of both sex.
  • More than 18 years.
  • Accepting all study requirements.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carotid Stenosis

Interventions

TicagrelorClopidogrel

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Osama Ibrahim Aboelfath Ibrahim

Study Record Dates

First Submitted

September 12, 2019

First Posted

September 16, 2019

Study Start

January 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 23, 2021

Record last verified: 2021-03