Intracranial AneurysmsPhase 4NCT06486363
Comparison of the Antiplatelet Efficacy of Aspirin Combined With Clopidogrel and Aspirin Combined With Half-dose Ticagrelor in Patients With Unruptured Intracranial Aneurysms With Normal CYP2C19 Metabolizer Phenotype
A Phase 4 study testing Aspirin combined with clopidogrel and Aspirin combined with half-dose ticagrelor in people with Intracranial Aneurysms and Antiplatelet Drugs, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
The goal of this clinical trial is to compare the antiplatelet efficacy of aspirin combined with clopidogrel and aspirin combined with half-dose ticagrelor in in patients with unruptured intracranial aneurysms with normal CYP2C19 metabolizer phenotype. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Intracranial Aneurysms, Antiplatelet Drugs
- What is being tested?
- Aspirin combined with clopidogrel and Aspirin combined with half-dose ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unruptured intracranial aneurysms who are scheduled for stent-assisted embolization;
- mRS score less than or equal to 2 on admission;
- Normal CYP2C19 metabolizer genotype;
- Age 20 or above, 70 or below, regardless of gender;
- The subject or the entrusted family member voluntarily signed the informed consent for this trial
Who cannot join
- Use of drugs that affect coagulation function or significant abnormalities in platelet/coagulation function before admission;
- Previous history of cardiovascular and cerebrovascular disease;
- Complications of major organ dysfunction, chronic inflammatory diseases or malignant tumors at admission;
- Known allergy or contraindication to heparin, aspirin, clopidogrel, or ticagrelor;
- Patients with any severe or active pathological bleeding;
- Pregnant and lactating female;
- Those deemed unsuitable to participate in this trial by the responsible physician
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to compare the antiplatelet efficacy of aspirin combined with clopidogrel and aspirin combined with half-dose ticagrelor in in patients with unruptured intracranial aneurysms with normal CYP2C19 metabolizer phenotype. The main questions it aims to answer are:
If aspirin combined with half-dose ticagrelor is comparable to or better than aspirin combined with clopidogrel? What medical problems do participants have when taking aspirin combined with half-dose ticagrelor? Researchers will compare aspirin combined with half-dose ticagrelor to aspirin combined with clopidogrel to see if aspirin combined with half-dose ticagrelor works to treat patients with unruptured intracranial aneurysms received endovascular treatment.
Read more
Participants will:
Take aspirin combined with half-dose ticagrelor or aspirin combined with clopidogrel every day for 6 months Visit the clinic 1 month and 6 months for checkups and tests
- Conditions
- Intracranial Aneurysms, Antiplatelet Drugs
- Being tested
- Aspirin combined with clopidogrel, Aspirin combined with half-dose ticagrelor
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin combined with clopidogrelDrug
Participants in this group shall take Aspirin (100 mg/day) + clopidogrel (75 mg/day) for at least 5 days before receiving stent-assisted coil embolization, and take same medication for 6 months after endovascular treatment
Aspirin combined with half-dose ticagrelorDrug
Participants in this group shall take Aspirin (100 mg/day) + half dose of ticagrelor (45 mg, 12 hours/time), at least for 3 days before receiving stent-assisted coil embolization, and take same medication for 6 months after endovascular treatment
| Study group | Role | What they receive |
|---|---|---|
| Aspirin combined with clopidogrel | Active comparator | Participants in this group shall take Aspirin (100 mg/day) + clopidogrel (75 mg/day) for at least 5 days before receiving stent-assisted coil embolization, and take same medication for 6 months after endovascular treatment Receives: Drug: Aspirin combined with clopidogrel |
| Aspirin combined with half-dose ticagrelor | Experimental | Participants in this group shall take Aspirin (100 mg/day) + half dose of ticagrelor (45 mg, 12 hours/time), at least for 3 days before receiving stent-assisted coil embolization, and take same medication for 6 months after endovascular treatment. Receives: Drug: Aspirin combined with half-dose ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of cerebral stroke
Incidence rate of cerebral stroke, including ischemic stroke and hemorrhagic stroke
Measured: The entire experimental process after endovascular treatment
Modified Rankin Scale
Modified Rankin Scale ( The scale runs from 0 to 6, 0 means perfect health and 6 means death)
Measured: 6 months after endovascular surgery
Mini-mental state examination
The MMSE examination includes time and place orientation, registration, attention and calculation, recall, language, repitition, complex commands. Score excess 24 or more indicates a normal cognition, 19-23 points indicates mild cognitive impairment, score of 10-18 points indicates moderate cognitive impairment and score below 9 points indicates severe cognitive impairment
Measured: 6 months after endovascular surgery
Secondary outcomes (1)
Platelet inhibition rate/platelet aggregation rate
Platelet inhibition rate/platelet aggregation rate
Measured: 1 day before endovascular surgery/3 days after endovascular surgery/3 and 6 months after endovascular surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To compare the antiplatelet efficacy of aspirin combined with clopidogrel and aspirin combined with half-dose ticagrelor in in patients with unruptured intracranial aneurysms with normal CYP2C19 metabolizer phenotype
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shijie Na, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Shijie Na, Doctor, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486363
- Sponsor's protocol ID
- 2023-536-02
- Status last verified
- Jul 2024
- First submitted
- 19 Jun 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Antiplatelet Efficacy of Aspirin Combined With Clopidogrel and Aspirin Combined With Half-dose Ticagrelor in Patients With Unruptured Intracranial Aneurysms With Normal CYP2C19 Metabolizer Phenotype
- ClinicalTrials.gov ID
- NCT06486363
- Acronym / sponsor ID
- 2023-536-02
- Conditions
- Intracranial Aneurysms, Antiplatelet Drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 3 Jul 2024 (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.
The goal of this clinical trial is to compare the antiplatelet efficacy of aspirin combined with clopidogrel and aspirin combined with half-dose ticagrelor in in patients with unruptured intracranial aneurysms with normal CYP2C19 metabolizer phenotype. The main questions it aims to answer are:
If aspirin combined with half-dose ticagrelor is comparable to or better than aspirin combined with clopidogrel? What medical problems do participants have when taking aspirin combined with half-dose ticagrelor? Researchers will compare aspirin combined with half-dose ticagrelor to aspirin combined with clopidogrel to see if aspirin combined with half-dose ticagrelor works to treat patients with unruptured intracranial aneurysms received endovascular treatment.
Participants will:
Take aspirin combined with half-dose ticagrelor or aspirin combined with clopidogrel every day for 6 months Visit the clinic 1 month and 6 months for checkups and tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To compare the antiplatelet efficacy of aspirin combined with clopidogrel and aspirin combined with half-dose ticagrelor in in patients with unruptured intracranial aneurysms with normal CYP2C19 metabolizer phenotype
| Arm | Type | Receives |
|---|---|---|
| Aspirin combined with clopidogrel | Active comparator | Drug: Aspirin combined with clopidogrelParticipants in this group shall take Aspirin (100 mg/day) + clopidogrel (75 mg/day) for at least 5 days before receiving stent-assisted coil embolization, and take same medication for 6 months after endovascular treatment |
| Aspirin combined with half-dose ticagrelor | Experimental | Drug: Aspirin combined with half-dose ticagrelorParticipants in this group shall take Aspirin (100 mg/day) + half dose of ticagrelor (45 mg, 12 hours/time), at least for 3 days before receiving stent-assisted coil embolization, and take same medication for 6 months after endovascular treatment. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with unruptured intracranial aneurysms who are scheduled for stent-assisted embolization;
- mRS score less than or equal to 2 on admission;
- Normal CYP2C19 metabolizer genotype;
- Age 20 or above, 70 or below, regardless of gender;
- The subject or the entrusted family member voluntarily signed the informed consent for this trial
Key exclusion criteria (7 listed)
- Use of drugs that affect coagulation function or significant abnormalities in platelet/coagulation function before admission;
- Previous history of cardiovascular and cerebrovascular disease;
- Complications of major organ dysfunction, chronic inflammatory diseases or malignant tumors at admission;
- Known allergy or contraindication to heparin, aspirin, clopidogrel, or ticagrelor;
- Patients with any severe or active pathological bleeding;
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 |
|---|---|---|
| Aspirin combined with clopidogrelParticipants in this group shall take Aspirin (100 mg/day) + clopidogrel (75 mg/day) for at least 5 days before receiving stent-assisted coil embolization, and take same medication for 6 months after endovascular treatment | Drug | Aspirin combined with clopidogrel |
| Aspirin combined with half-dose ticagrelorParticipants in this group shall take Aspirin (100 mg/day) + half dose of ticagrelor (45 mg, 12 hours/time), at least for 3 days before receiving stent-assisted coil embolization, and take same medication for 6 months after endovascular treatment | Drug | Aspirin combined with half-dose ticagrelor |
Primary outcome
Incidence rate of cerebral stroke
Time frame: The entire experimental process after endovascular treatment
Incidence rate of cerebral stroke, including ischemic stroke and hemorrhagic stroke
Modified Rankin Scale
Time frame: 6 months after endovascular surgery
Modified Rankin Scale ( The scale runs from 0 to 6, 0 means perfect health and 6 means death)
Mini-mental state examination
Time frame: 6 months after endovascular surgery
The MMSE examination includes time and place orientation, registration, attention and calculation, recall, language, repitition, complex commands. Score excess 24 or more indicates a normal cognition, 19-23 points indicates mild cognitive impairment, score of 10-18 points indicates moderate cognitive impairment and score below 9 points indicates severe cognitive impairment
1 secondary outcome
Platelet inhibition rate/platelet aggregation rate
Time frame: 1 day before endovascular surgery/3 days after endovascular surgery/3 and 6 months after endovascular surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Shijie Na, Doctor principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing university
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin combined with clopidogrel and Aspirin combined with half-dose ticagrelor in people with Intracranial Aneurysms and Antiplatelet Drugs, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 29 Jul 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zong Zhuang, Doctor (+86 15850560410, zhuangzong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of cerebral stroke (time frame: The entire experimental process after endovascular treatment). The study lists 3 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 29 Jul 2024.