Condition or disease | Intervention/treatment | Phase |
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Unruptured Intracranial Aneurysm Stents Antiplatelet Drugs | Drug: Aspirin and clopidogrel/Ticagrelor Device: Light transmittance aggregometry | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 314 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Study of Platelet Function Test in the Application of Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms |
Actual Study Start Date : | July 1, 2019 |
Actual Primary Completion Date : | July 20, 2020 |
Actual Study Completion Date : | August 13, 2020 |
Arm | Intervention/treatment |
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Experimental: Monitoring Arm
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.
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Drug: Aspirin and clopidogrel/Ticagrelor
The modification of aspirin and clopidogrel/ticagrelor maintenance doses based on a biomarker assays.
Device: Light transmittance aggregometry point-of-care method to assess platelet function by light transmittance aggregometry.
Drug: Aspirin and clopidogrel/Ticagrelor maintenance dose of aspirin, clopidogrel and ticagrelor.
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Experimental: Conventional Arm
Randomization: without light transmittance aggregometry, standard antiplatelet regimen was used for unruptured aneurysm patients with intracranial stent.
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Drug: Aspirin and clopidogrel/Ticagrelor
maintenance dose of aspirin, clopidogrel and ticagrelor.
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China, 北京市 | |
Beijing Neurosurgical Institute and Beijing Tiantan Hospital | |
Beijing, 北京市, China, 100050 |
Tracking Information | |||||||
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First Submitted Date ICMJE | June 16, 2019 | ||||||
First Posted Date ICMJE | June 18, 2019 | ||||||
Last Update Posted Date | September 9, 2020 | ||||||
Actual Study Start Date ICMJE | July 1, 2019 | ||||||
Actual Primary Completion Date | July 20, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
A thromboembolic event during the early periprocedural period (within 7 days after stent placement) [ Time Frame: within 7 days of patients' enrolled ] A thromboembolic event is defined as a thromboembolism detected during the coiling procedure or ischemic stroke with evidence of infarction on diffusion weighted imaging, which related to the treated aneurysm.
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
A thromboembolic event during the 1 month follow-up periods. [ Time Frame: within 1 month of patients' enrolled. ] | ||||||
Original Secondary Outcome Measures ICMJE |
A thromboembolic event at the 6 months follow-up periods and at the 2 years follow-up periods. [ Time Frame: within 6 months and 2 years of patients' enrolled ] | ||||||
Current Other Pre-specified Outcome Measures |
Major bleeding and minor bleeding [ Time Frame: within 1 month of patients' enrolled. ] Bleeding complications were accorded to Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria.
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Original Other Pre-specified Outcome Measures |
Major bleeding and minor bleeding [ Time Frame: within 2 years of patients' enrolled ] | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Application of Platelet Function Test in Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms | ||||||
Official Title ICMJE | A Study of Platelet Function Test in the Application of Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms | ||||||
Brief 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). 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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
314 | ||||||
Original Estimated Enrollment ICMJE |
316 | ||||||
Actual Study Completion Date ICMJE | August 13, 2020 | ||||||
Actual Primary Completion Date | July 20, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | China | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03989557 | ||||||
Other Study ID Numbers ICMJE | BNI-2019002 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Beijing Neurosurgical Institute | ||||||
Study Sponsor ICMJE | Beijing Neurosurgical Institute | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Beijing Neurosurgical Institute | ||||||
Verification Date | June 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |