Carotid StenosisPhase 1NCT04091074
Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting
A Phase 1 study testing Ticagrelor, Clopidogrel and Carotid stenting in people with Carotid Stenosis, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Ticagrelor, Clopidogrel and Carotid stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ischemis stroke of both sex.
- More than 18 years.
- Accepting all study requirements.
Who cannot join
- Refuse to comply with all study requirements.
- bleeding tendency or liver diseases
About this study
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
- Conditions
- Carotid Stenosis
- Being tested
- Ticagrelor, Clopidogrel, Carotid stenting
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Half of patients undergoing carotid stenting take ticagrelor+aspirin
ClopidogrelDrug
Other half ofpatients undergoing carotid stenting take clopidogrel+aspirin
Carotid stentingProcedure or surgery
Patients with carotid stenosis will undergo carotid stenting
| Study group | Role | What they receive |
|---|---|---|
| aspirin + ticagrelor before carotid stenting | Active comparator | patients undergoing carotid stenting take aspirin 150 mg + ticagrelor 90mg for 15 days before carotid stenting Receives: Drug: Ticagrelor; Procedure: 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 Receives: Drug: Clopidogrel; Procedure: Carotid stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 15 days before carotid stenting
Secondary outcomes (1)
Pattern of carotid stenosis
Incidence of carotid stenosis in patients come to Assiut university hospitals
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start1 Jan 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Ibrahim Aboelfath Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091074
- Sponsor's protocol ID
- Ticagrelor in carotid stenting
- Status last verified
- Mar 2021
- First submitted
- 12 Sep 2019
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting
- ClinicalTrials.gov ID
- NCT04091074
- Acronym / sponsor ID
- Ticagrelor in carotid stenting
- Conditions
- Carotid Stenosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aspirin + ticagrelor before carotid stenting | Active comparator | Drug: Ticagrelor, Procedure: Carotid stentingpatients undergoing carotid stenting take aspirin 150 mg + ticagrelor 90mg for 15 days before carotid stenting |
| aspirin + clopidogrel before carotid stenting | Active comparator | Drug: Clopidogrel, Procedure: Carotid stentingpatients undergoing carotid stenting take aspirin 150 mg + clopidogrel 75 mg for 15 days before carotid stenting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ischemis stroke of both sex.
- More than 18 years.
- Accepting all study requirements.
Key exclusion criteria (2 listed)
- Refuse to comply with all study requirements.
- bleeding tendency or liver diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorHalf of patients undergoing carotid stenting take ticagrelor+aspirin | Drug | aspirin + ticagrelor before carotid stenting |
| ClopidogrelOther half ofpatients undergoing carotid stenting take clopidogrel+aspirin | Drug | aspirin + clopidogrel before carotid stenting |
| Carotid stentingPatients with carotid stenosis will undergo carotid stenting | Procedure or surgery | aspirin + clopidogrel before carotid stenting, aspirin + ticagrelor before carotid stenting |
Primary outcome
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
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
1 secondary outcome
Pattern of carotid stenosis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ticagrelor, Clopidogrel and Carotid stenting in people with Carotid Stenosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare efficacy of ticagrelor and clopidogrel in patients undergoing carotid stenting (time frame: 15 days before carotid stenting). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.