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Completed

NCT Number: NCT03989557

Application of Platelet Function Test in 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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);
  • 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.

Treatment and study plan

Aspirin and clopidogrel/Ticagrelor

Drug

The modification of aspirin and clopidogrel/ticagrelor maintenance doses based on a biomarker assays.

Light transmittance aggregometry

Device

point-of-care method to assess platelet function by light transmittance aggregometry.

Primary outcomes

  1. 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.

Secondary outcomes

  1. A thromboembolic event during the 1 month follow-up periods.

    Time frame: within 1 month of patients' enrolled.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Beijing Neurosurgical Institute

Other

Registry information

Official study title

A Study of Platelet Function Test in the Application of Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms

Acronym: APISIA Trail

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2019
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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