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Application of Platelet Function Test in Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms (APISIA Trail)

Primary Purpose

Unruptured Intracranial Aneurysm, Stents, Antiplatelet Drugs

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Aspirin and clopidogrel/Ticagrelor
Light transmittance aggregometry
Aspirin and clopidogrel/Ticagrelor
Sponsored by
Beijing Neurosurgical Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unruptured Intracranial Aneurysm focused on measuring Platelet function test, high platelet reactivity, light transmittance platelet aggregometry

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 - 80, male or non-pregnant female;
  2. patients have unruptured aneurysm who plan to undergo intracranial stent placement;
  3. patients with less than 2 of modified Rankin scale score at the day of enrollment;
  4. patients who is able to understand the objective of the trial, agrees and signs the written informed consent form.

Exclusion Criteria:

  1. The complications related to operation or material quality, such as guidewire pierces out blood vessel, coil herniation, incompletely opened stent, etc;
  2. Simultaneous treatment of other cerebrovascular diseases, such as intracranial arteriovenous malformation, Intracranial arteriovenous fistula, etc;
  3. Patient with history of hypersensitivity of aspirin, clopidogrel, or ticagrelor;
  4. Patients with preoperative prophylactic use of tirofiban;
  5. Patients with a high possibility of active bleeding, such as symptomatic intracranial hemorrhage or active gastric ulcer; or patients with coagulopathy;
  6. Patients with thrombocytopenia (platelet count <100,000/mm3 within three months before enrollment);
  7. patient using anticoagulant;
  8. Pregnant or lactating women;
  9. Patients with malignant diseases, such as liver disease, kidney disease, congestive heart failure, malignant tumors, etc;
  10. Poor compliance patients.

Sites / Locations

  • Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Monitoring Arm

Conventional Arm

Arm Description

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.

Randomization: without light transmittance aggregometry, standard antiplatelet regimen was used for unruptured aneurysm patients with intracranial stent.

Outcomes

Primary Outcome Measures

A thromboembolic event during the early periprocedural period (within 7 days after stent placement)
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 Outcome Measures

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

Full Information

First Posted
June 16, 2019
Last Updated
September 7, 2020
Sponsor
Beijing Neurosurgical Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03989557
Brief Title
Application of Platelet Function Test in Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms
Acronym
APISIA Trail
Official Title
A Study of Platelet Function Test in the Application of Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 20, 2020 (Actual)
Study Completion Date
August 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Neurosurgical Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unruptured Intracranial Aneurysm, Stents, Antiplatelet Drugs
Keywords
Platelet function test, high platelet reactivity, light transmittance platelet aggregometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monitoring Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Arm
Arm Type
Experimental
Arm Description
Randomization: without light transmittance aggregometry, standard antiplatelet regimen was used for unruptured aneurysm patients with intracranial stent.
Intervention Type
Drug
Intervention Name(s)
Aspirin and clopidogrel/Ticagrelor
Intervention Description
The modification of aspirin and clopidogrel/ticagrelor maintenance doses based on a biomarker assays.
Intervention Type
Device
Intervention Name(s)
Light transmittance aggregometry
Intervention Description
point-of-care method to assess platelet function by light transmittance aggregometry.
Intervention Type
Drug
Intervention Name(s)
Aspirin and clopidogrel/Ticagrelor
Intervention Description
maintenance dose of aspirin, clopidogrel and ticagrelor.
Primary Outcome Measure Information:
Title
A thromboembolic event during the early periprocedural period (within 7 days after stent placement)
Description
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.
Time Frame
within 7 days of patients' enrolled.
Secondary Outcome Measure Information:
Title
A thromboembolic event during the 1 month follow-up periods.
Time Frame
within 1 month of patients' enrolled.
Other Pre-specified Outcome Measures:
Title
Major bleeding and minor bleeding
Description
Bleeding complications were accorded to Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria.
Time Frame
within 1 month of patients' enrolled.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
City
Beijing
State/Province
北京市
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34538087
Citation
Li W, Zhu W, Wang A, Zhang G, Zhang Y, Wang K, Zhang Y, Wang C, Zhang L, Zhao H, Wang P, Chen K, Liu J, Yang X. Effect of Adjusted Antiplatelet Therapy on Preventing Ischemic Events After Stenting for Intracranial Aneurysms. Stroke. 2021 Dec;52(12):3815-3825. doi: 10.1161/STROKEAHA.120.032989. Epub 2021 Sep 20.
Results Reference
derived

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

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