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| Name | Class |
|---|---|
| Xuanwu Hospital, Beijing | OTHER |
| Chinese PLA General Hospital | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Peking University International Hospital |
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The use of intracranial stents expands the possibilities for endovascular treatment of intracranial aneurysms and improves the success rate. However, it also increases the risk of ischemic complications in patients. The current standard dual antiplatelet regimen is considered crucial in reducing thrombotic events. Nevertheless, some patients exhibit resistance to antiplatelet drugs, which puts them at a higher risk of thrombotic events. In clinical practice, there is a lack of standardized platelet function testing and consensus on adjusting antiplatelet drug programs. This study conducted a multi-center, prospective cluster randomized controlled trial to investigate whether antiplatelet adjustment therapy guided by light transmittance aggregometry (LTA) detection can decrease the occurrence of ischemic events after stent implantation in patients with unruptured intracranial aneurysms. Additionally, the study aimed to establish a set of standardized antiplatelet regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | Continue to use the center's original antiplatelet regimen: oral aspirin 100 mg and clopidogrel 75 mg daily | |
| test group | Experimental | Use a guided antiplatelet regimen based on LTA testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjustment of Antiplatelet Drugs | Drug | The maximum platelet aggregation rate induced by arachidonic acid (AA-MPA)≥20%, give aspirin 200mg qd. The maximum platelet aggregation rate induced by adenosine diphosphatase (ADP-MPA)≥36.4% for flow diversion, give ticagrelor 60mg bid. ADP-MPA≥42.9% for stent-assisted coil embolization,give ticagrelor 60mg bid. ADP-MPA<20%, give clopidogrel 37.5mg qd. The timing of drug adjustment should be at least 1 day before stent implantation, and the LTA testing should be performed again 48 hours after the drug adjustment. For patients whose ADP-MPA does not reach the normal range, a second antiplatelet drug adjustment should be performed: ticagrelor overdose: reduce to 45mg bid; ticagrelor resistance, increase to 90 mg bid. |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic events | ischemic stroke, transient ischemic stroke (TIA), stent thrombosis | 30 days after stent implantation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Bleeding events | The primary safety endpoint was severe or life-threatening bleeding, moderate bleeding and minor bleeding, assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) classification. | 30 days after stent implantation. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xinjian Yang, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan hospital | Beijing | Beijing Municipality | 100070 | China | ||
| Department of Neurosurgery, Beijing Tiantan Hospital. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36746550 | Result | Zhou Y, Li W, Wang C, Xie R, Zhu Y, Peng Q, Zhang L, Zhang H, Gu Y, Mu S, Liu J, Yang X. Roles of light transmission aggregometry and CYP2C19 genotype in predicting ischaemic complications during interventional therapy for intracranial aneurysms. Stroke Vasc Neurol. 2023 Aug;8(4):327-334. doi: 10.1136/svn-2022-001720. Epub 2023 Feb 6. | |
| 8204123 |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| OTHER |
| Peking University First Hospital | OTHER |
| Hebei Medical University Third Hospital | OTHER |
| Tianjin Medical University General Hospital | OTHER |
cluster randomized controlled cohort study
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To ensure the reliability of the research results, a study committee consisting of 5 members will be formed. The committee comprised a 2-member data safety monitoring committee and a 3-member clinical event review committee. Each reported ischemic event and bleeding event were assessed independently by three members of the clinical event adjudication committee. These committee members were blinded to the treatment group assignments. Any disagreements were resolved by a third member of the clinical events adjudication committee. All five committee members reviewed and resolved any discrepancies through consensus.
|
| Beijing |
| Beijing Municipality |
| 100070 |
| China |
| GUSTO investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993 Sep 2;329(10):673-82. doi: 10.1056/NEJM199309023291001. |
| 19423857 | Result | Easton JD, Saver JL, Albers GW, Alberts MJ, Chaturvedi S, Feldmann E, Hatsukami TS, Higashida RT, Johnston SC, Kidwell CS, Lutsep HL, Miller E, Sacco RL; American Heart Association; American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Interdisciplinary Council on Peripheral Vascular Disease. Definition and evaluation of transient ischemic attack: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; and the Interdisciplinary Council on Peripheral Vascular Disease. The American Academy of Neurology affirms the value of this statement as an educational tool for neurologists. Stroke. 2009 Jun;40(6):2276-93. doi: 10.1161/STROKEAHA.108.192218. Epub 2009 May 7. |
| 23652265 | Result | Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7. |
| 15718113 | Result | Gulliford MC, Adams G, Ukoumunne OC, Latinovic R, Chinn S, Campbell MJ. Intraclass correlation coefficient and outcome prevalence are associated in clustered binary data. J Clin Epidemiol. 2005 Mar;58(3):246-51. doi: 10.1016/j.jclinepi.2004.08.012. |
| 40100020 | Derived | Zhou Y, Wang J, Li W, Liu J, Wang A, Zhang Y, Mu S, Xie R, Peng Q, Zhang L, Luo B, Zhao Y, Wang Y, Zhang Z, Lin Y, Zhang P, Zhang J, Li L, Yin X, Xiao F, Lin Y, Liu X, Bian Y, Wang S, Li J, Zhang X, Hasan DM, Krings T, Zhang H, Yang X. Guided Antiplatelet Therapy for Stent-Treated Intracranial Aneurysms: A Cluster-Randomized Trial. Radiology. 2025 Mar;314(3):e241509. doi: 10.1148/radiol.241509. |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020521 | Stroke |