Guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms

NCT05825391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 590

Last updated 2023-11-18

No results posted yet for this study

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

Interventions

DRUG

Adjustment of Antiplatelet Drugs

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.

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    collaborator OTHER
  • Chinese PLA General Hospital

    collaborator OTHER
  • Beijing Chao Yang Hospital

    collaborator OTHER
  • Peking University International Hospital

    collaborator OTHER
  • Peking University First Hospital

    collaborator OTHER
  • Hebei Medical University Third Hospital

    collaborator OTHER
  • Tianjin Medical University General Hospital

    collaborator OTHER
  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Xinjian Yang, MD · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2023-10-03
Completion
2023-10-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05825391 on ClinicalTrials.gov