Unruptured Intracranial AneurysmPhase 4APISIA TrailNCT03989557
Application of Platelet Function Test in Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms
A Phase 4 study testing Aspirin and clopidogrel/Ticagrelor and Light transmittance aggregometry in people with Unruptured Intracranial Aneurysm and Stents, run by Beijing Neurosurgical Institute at 1 site in China.
Trial summary
This study was designed to identify high platelet reactivity (HPR) who might have in-stent thrombosis in unruptured aneurysm with intracranial stent placement with light transmittance platelet aggregometry (LTA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unruptured Intracranial Aneurysm, Stents, Antiplatelet Drugs
- What is being tested?
- Aspirin and clopidogrel/Ticagrelor and Light transmittance aggregometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 13 Aug 2020
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80, male or non-pregnant female;
- patients have unruptured aneurysm who plan to undergo intracranial stent placement;
- patients with less than 2 of modified Rankin scale score at the day of enrollment;
- patients who is able to understand the objective of the trial, agrees and signs the written informed consent form.
Who cannot join
- The complications related to operation or material quality, such as guidewire pierces out blood vessel, coil herniation, incompletely opened stent, etc;
- Simultaneous treatment of other cerebrovascular diseases, such as intracranial arteriovenous malformation, Intracranial arteriovenous fistula, etc;
- Patient with history of hypersensitivity of aspirin, clopidogrel, or ticagrelor;
- Patients with preoperative prophylactic use of tirofiban;
- Patients with a high possibility of active bleeding, such as symptomatic intracranial hemorrhage or active gastric ulcer; or patients with coagulopathy;
- Patients with thrombocytopenia (platelet count <100,000/mm3 within three months before enrollment);
Show all 10Show fewer
- patient using anticoagulant;
- Pregnant or lactating women;
- Patients with malignant diseases, such as liver disease, kidney disease, congestive heart failure, malignant tumors, etc;
- Poor compliance patients.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
About this study
Official title: A Study of Platelet Function Test in the Application of Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms
This study was designed to identify high platelet reactivity (HPR) who might have in-stent thrombosis in unruptured aneurysm with intracranial stent placement with light transmittance platelet aggregometry (LTA). For HPR patients, higher ischemic stroke rate maybe occurred, and we hypothesis that dose adjustment of aspirin and clopidogrel based on LTA monitoring maybe reduces the rate of ischemic stroke compared to a standard strategy after intracranial stent implantation at early periprocedural period and 1 month follow-up period.
Read the detailed description
For the patients of unruptured intracranial aneurysms with stent placement, standard antiplatelet therapy (100mg aspirin + 75mg clopidogrel) is considered to be the most effective antiplatelet regimen in reducing ischemic complications. However, despite the use of standard antiplatelet therapy, a number of patients continue to have ischemic events. A hypothesis is that high platelet reactivity (HPR) patients identified by platelet function test have higher ratio of the ischemic events, and dose adjustment of HPR patients reduces the rate of the ischemic complications at early periprocedural period and follow-up period.
Objectives: The study aim to evaluated the superiority of the strategy of platelet function test(Monitoring Arm) with the modified strategy in HPR patients compared to the standard strategy (Conventional Arm) whether reduce the primary endpoint after intracranial stent implantation at early periprocedural period (7 days) and 1 months follow-up period.
- Conditions
- Unruptured Intracranial Aneurysm, Stents, Antiplatelet Drugs
- Being tested
- Aspirin and clopidogrel/Ticagrelor, Light transmittance aggregometry
- Keywords
- Platelet function test, high platelet reactivity, light transmittance platelet aggregometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin and clopidogrel/TicagrelorDrug
The modification of aspirin and clopidogrel/ticagrelor maintenance doses based on a biomarker assays.
Light transmittance aggregometryDevice
point-of-care method to assess platelet function by light transmittance aggregometry.
Aspirin and clopidogrel/TicagrelorDrug
maintenance dose of aspirin, clopidogrel and ticagrelor.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring Arm | Experimental | Randomization: based on light transmittance aggregometry, modified dose of antiplatelet therapy(aspirin and ticagrelor) was used for high platelet reactivity(HPR) patients with intracranial stent placement, and standard antiplatelet regimen(aspirin and clopidogrel) was used in non-HPR patients. Receives: Drug: Aspirin and clopidogrel/Ticagrelor; Device: Light transmittance aggregometry |
| Conventional Arm | Experimental | Randomization: without light transmittance aggregometry, standard antiplatelet regimen was used for unruptured aneurysm patients with intracranial stent. Receives: Drug: Aspirin and clopidogrel/Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
A thromboembolic event during the early periprocedural period (within 7 days after stent placement)
The thromboembolic events were assessed by clinical examination. The thromboembolic events was a composite of ischemic stroke, transient ischemic attack, stent thrombosis, urgent revascularization, myocardial infarction, cerebrovascular death.
Measured: within 7 days of patients' enrolled.
Secondary outcomes (1)
A thromboembolic event during the 1 month follow-up periods.
Measured: within 1 month of patients' enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Jul 2019
- Primary completion20 Jul 2020
- Study completion13 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unruptured Intracranial AneurysmStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Neurosurgical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989557
- Sponsor's protocol ID
- BNI-2019002
- Acronym
- APISIA Trail
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li W, Zhu W, Wang A, Zhang G, Zhang Y, Wang K, Zhang Y, Wang C, Zhang L, Zhao H, Wang P, Chen K, Liu J, Yang X. Effect of Adjusted Antiplatelet Therapy on Preventing Ischemic Events After Stenting for Intracranial Aneurysms. Stroke. 2021 Dec;52(12):3815-3825. doi: 10.1161/STROKEAHA.120.032989. Epub 2021 Sep 20.
PubMed 34538087
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Platelet Function Test in the Application of Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT03989557
- Acronym / sponsor ID
- APISIA Trail / BNI-2019002
- Conditions
- Unruptured Intracranial Aneurysm, Stents, Antiplatelet Drugs
- Keywords
- Platelet function test, high platelet reactivity, light transmittance platelet aggregometry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Beijing Neurosurgical InstituteUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 18 Jun 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.
This study was designed to identify high platelet reactivity (HPR) who might have in-stent thrombosis in unruptured aneurysm with intracranial stent placement with light transmittance platelet aggregometry (LTA). For HPR patients, higher ischemic stroke rate maybe occurred, and we hypothesis that dose adjustment of aspirin and clopidogrel based on LTA monitoring maybe reduces the rate of ischemic stroke compared to a standard strategy after intracranial stent implantation at early periprocedural period and 1 month follow-up period.
Detailed description
For the patients of unruptured intracranial aneurysms with stent placement, standard antiplatelet therapy (100mg aspirin + 75mg clopidogrel) is considered to be the most effective antiplatelet regimen in reducing ischemic complications. However, despite the use of standard antiplatelet therapy, a number of patients continue to have ischemic events. A hypothesis is that high platelet reactivity (HPR) patients identified by platelet function test have higher ratio of the ischemic events, and dose adjustment of HPR patients reduces the rate of the ischemic complications at early periprocedural period and follow-up period.
Objectives: The study aim to evaluated the superiority of the strategy of platelet function test(Monitoring Arm) with the modified strategy in HPR patients compared to the standard strategy (Conventional Arm) whether reduce the primary endpoint after intracranial stent implantation at early periprocedural period (7 days) and 1 months follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring Arm | Experimental | Drug: Aspirin and clopidogrel/Ticagrelor, Device: Light transmittance aggregometryRandomization: based on light transmittance aggregometry, modified dose of antiplatelet therapy(aspirin and ticagrelor) was used for high platelet reactivity(HPR) patients with intracranial stent placement, and standard antiplatelet regimen(aspirin and clopidogrel) was used in non-HPR patients. |
| Conventional Arm | Experimental | Drug: Aspirin and clopidogrel/TicagrelorRandomization: without light transmittance aggregometry, standard antiplatelet regimen was used for unruptured aneurysm patients with intracranial stent. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 - 80, male or non-pregnant female;
- patients have unruptured aneurysm who plan to undergo intracranial stent placement;
- patients with less than 2 of modified Rankin scale score at the day of enrollment;
- patients who is able to understand the objective of the trial, agrees and signs the written informed consent form.
Key exclusion criteria (10 listed)
- The complications related to operation or material quality, such as guidewire pierces out blood vessel, coil herniation, incompletely opened stent, etc;
- Simultaneous treatment of other cerebrovascular diseases, such as intracranial arteriovenous malformation, Intracranial arteriovenous fistula, etc;
- Patient with history of hypersensitivity of aspirin, clopidogrel, or ticagrelor;
- Patients with preoperative prophylactic use of tirofiban;
- Patients with a high possibility of active bleeding, such as symptomatic intracranial hemorrhage or active gastric ulcer; or patients with coagulopathy;
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 and clopidogrel/TicagrelorThe modification of aspirin and clopidogrel/ticagrelor maintenance doses based on a biomarker assays. | Drug | Monitoring Arm |
| Light transmittance aggregometrypoint-of-care method to assess platelet function by light transmittance aggregometry. | Device | Monitoring Arm |
| Aspirin and clopidogrel/Ticagrelormaintenance dose of aspirin, clopidogrel and ticagrelor. | Drug | Conventional Arm, Monitoring Arm |
Primary outcome
A thromboembolic event during the early periprocedural period (within 7 days after stent placement)
Time frame: within 7 days of patients' enrolled.
The thromboembolic events were assessed by clinical examination. The thromboembolic events was a composite of ischemic stroke, transient ischemic attack, stent thrombosis, urgent revascularization, myocardial infarction, cerebrovascular death.
1 secondary outcome
A thromboembolic event during the 1 month follow-up periods.
Time frame: within 1 month of patients' enrolled.
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 9 Sep 2020.
- Derived from this study: PubMed 34538087Li W, Zhu W, Wang A, Zhang G, Zhang Y, Wang K, Zhang Y, Wang C, Zhang L, Zhao H, Wang P, Chen K, Liu J, Yang X. Effect of Adjusted Antiplatelet Therapy on Preventing Ischemic Events After Stenting for Intracranial Aneurysms. Stroke. 2021 Dec;52(12):3815-3825. doi: 10.1161/STROKEAHA.120.032989. Epub 2021 Sep 20.
- Individual participant dataSharing planned: No
Related trials for Unruptured Intracranial Aneurysm
Not yet recruitingPhase 4
Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms
Unruptured Intracranial Aneurysms, Cerebrovascular Event
RecruitingObservational study
Prospective Observational Cohort Study for Predicting Unruptured Intracranial Aneurysm Rupture Risk Using Blood Pressure Variability and 3D Structural Evolution
Unruptured Intracranial Aneurysm, Intracranial Aneurysm Rupture
Active, not recruitingObservational study
China Treatment Trial for Tumor in Sellar Region With Unruptured Intracranial Aneurysm
Unruptured Intracranial Aneurysms, Pituitary Neuroendocrine Tumor
Recruiting
Multimodal Approach Feasability Study for Untreated and Unruptured Intracranial Aneurysms
Aneurysm Cerebral (Unruptured)
RecruitingObservational study
Unruptured Cerebral Aneurysm: Prediction of Evolution
Unruptured Intracranial Aneurysm
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 4 study testing Aspirin and clopidogrel/Ticagrelor and Light transmittance aggregometry in people with Unruptured Intracranial Aneurysm and Stents, run by Beijing Neurosurgical Institute at 1 site in China.
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 10 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 9 Sep 2020. 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 China. 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 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?
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?
A thromboembolic event during the early periprocedural period (within 7 days after stent placement) (time frame: within 7 days of patients' enrolled.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03989557, which also lists 1 linked publication.
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 9 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.