Cerebral AneurysmPhase 3TIC-TACNCT02675205
Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm
A Phase 3 study testing Clopidogrel, Ticagrelor and aspirin in people with Cerebral Aneurysm, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Part of interventional neuroradiology procedures for the treatment of selected cerebral aneurysms are now based on stenting. To reduce thromboembolic events, dual antiplatelet therapy (APT) combining aspirin and clopidogrel is proposed with close monitoring, since 1/3 of the patients are low responders due to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Aneurysm
- What is being tested?
- Clopidogrel, Ticagrelor and aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Dec 2020
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unruptured cerebral aneurysm
- elective endovascular treatment
- stenting required
- dual antiplatelet therapy required
Who cannot join
- -none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ticagrelor Versus Clopidogrel for Platelet Inhibition in Patients Undergoing Neurovascular Stenting for Intracranial Aneurysm
Part of interventional neuroradiology procedures for the treatment of selected cerebral aneurysms are now based on stenting. To reduce thromboembolic events, dual antiplatelet therapy (APT) combining aspirin and clopidogrel is proposed with close monitoring, since 1/3 of the patients are low responders due to variation of the biological response to clopidogrel . Ticagrelor is used by few teams but has never been evaluated in a randomized controlled trial. It could be an option for APT due to more reproducible response with less interindividual variability and reduced monitoring. The aim of this study is to demonstrate the interest of ticagrelor for the dual APT for platelet inhibition, in patients undergoing neurovascular stenting for cerebral aneurysm.
- Conditions
- Cerebral Aneurysm
- Being tested
- Clopidogrel, Ticagrelor, aspirin
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
clopidogrel: efficacy and safety in cerebral aneurysm stenting
TicagrelorDrug
ticagrelor:efficacy and safety in cerebral aneurysm stenting
aspirinDrug
| Study group | Role | What they receive |
|---|---|---|
| clopidogrel-aspirin | Active comparator | clopidogrel: 75mg and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery. Receives: Drug: Clopidogrel; Drug: aspirin |
| ticagrelor-aspirin | Experimental | Ticagrelor: 90 mg bid and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery Receives: Drug: Ticagrelor; Drug: aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients requiring at least one change of drug or dose adjustment to achieve platlet functional inhibition
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionJul 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675205
- Sponsor's protocol ID
- AGR_2014-33
- Other IDs
- 2014-005720-10, 2014
- Acronym
- TIC-TAC
- Status last verified
- Jul 2021
- First submitted
- 30 Dec 2015
- Last updated
- 16 Jul 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelor Versus Clopidogrel for Platelet Inhibition in Patients Undergoing Neurovascular Stenting for Intracranial Aneurysm
- ClinicalTrials.gov ID
- NCT02675205
- Acronym / sponsor ID
- TIC-TAC / AGR_2014-33
- Conditions
- Cerebral Aneurysm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Dec 2015 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 5 Feb 2016 (estimated)
- 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.
Part of interventional neuroradiology procedures for the treatment of selected cerebral aneurysms are now based on stenting. To reduce thromboembolic events, dual antiplatelet therapy (APT) combining aspirin and clopidogrel is proposed with close monitoring, since 1/3 of the patients are low responders due to variation of the biological response to clopidogrel . Ticagrelor is used by few teams but has never been evaluated in a randomized controlled trial. It could be an option for APT due to more reproducible response with less interindividual variability and reduced monitoring. The aim of this study is to demonstrate the interest of ticagrelor for the dual APT for platelet inhibition, in patients undergoing neurovascular stenting for cerebral aneurysm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clopidogrel-aspirin | Active comparator | Drug: Clopidogrel, Drug: aspirinclopidogrel: 75mg and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery. |
| ticagrelor-aspirin | Experimental | Drug: Ticagrelor, Drug: aspirinTicagrelor: 90 mg bid and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unruptured cerebral aneurysm
- elective endovascular treatment
- stenting required
- dual antiplatelet therapy required
Key exclusion criteria (1 listed)
- -none
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 |
|---|---|---|
| Clopidogrelclopidogrel: efficacy and safety in cerebral aneurysm stenting | Drug | clopidogrel-aspirin |
| Ticagrelorticagrelor:efficacy and safety in cerebral aneurysm stenting | Drug | ticagrelor-aspirin |
| aspirin | Drug | clopidogrel-aspirin, ticagrelor-aspirin |
Primary outcome
proportion of patients requiring at least one change of drug or dose adjustment to achieve platlet functional inhibition
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clopidogrel, Ticagrelor and aspirin in people with Cerebral Aneurysm, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
proportion of patients requiring at least one change of drug or dose adjustment to achieve platlet functional inhibition (time frame: 4 months). 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 16 Jul 2021.