Guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms

NCT05825391 | Completed DMC

• 1 other identifier: Xinjian Yang
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Intracranial Aneurysm

Keywords

Intracranial Aneurysm; Interventional Therapy; Stent; Platelet; Ischemic Stroke; Bleeding Event

Outcome Measures

Primary Outcomes (1)

• Ischemic events

  ischemic stroke, transient ischemic stroke (TIA), stent thrombosis

  30 days after stent implantation.

Other Outcomes (1)

• Bleeding events

  30 days after stent implantation.

Study Arms (2)

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

Drug: Adjustment of Antiplatelet Drugs

Interventions

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.

test group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unruptured intracranial aneurysms who received intracranial stenting,
• Standard dualantiplatelet therapy for at least 5 days before stent implantation,
• Patients aged 18-80,
• on the day of registration patients with a Modified Rankin Scale lower than 2,
• patients who agree and sign the consent form.

You may not qualify if:

• Patients with recurrent aneurysms after interventional therapy or clipping therapy,
• Patients with a history of allergy to aspirin, clopidogrel or ticagrelor,
• Patients who used tirofiban prophylactically before surgery,
• Possible active bleeding Patients with high blood pressure, such as symptomatic intracranial hemorrhage or active gastric ulcer; or patients with bleeding tendency or coagulation dysfunction,
• Any abnormal platelet count (normal value is 100-300 × 10\^9/L),
• Patients using anticoagulants,
• Pregnant or lactating women,
• Suffering from liver disease, kidney disease, congestive heart failure, malignant tumors and other malignant diseases.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: collaborator
• Beijing Tiantan Hospital: lead
• Chinese PLA General Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Peking University International Hospital: collaborator
• Peking University First Hospital: collaborator
• Hebei Medical University Third Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator

Study Sites (2)

Beijing Tiantan hospital

Beijing, Beijing Municipality, 100070, China

Location

Department of Neurosurgery, Beijing Tiantan Hospital.

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (6)

• 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.

  PMID: 36746550 RESULT

• 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.

  PMID: 8204123 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.

  PMID: 19423857 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.

  PMID: 23652265 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.

  PMID: 15718113 RESULT

• 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.

  PMID: 40100020 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm; Ischemic Stroke

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Stroke

Study Officials

• Xinjian Yang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cluster randomized controlled cohort study

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: May 4, 2023
• Primary Completion: October 3, 2023
• Study Completion: October 29, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (2)