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

Stents Clinical Trial

— APISIA Trail  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03989557
• Other study ID #: BNI-2019002
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2019
• Est. completion date: August 13, 2020

Study information

• Verified date: June 2020
• Source: Beijing Neurosurgical Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: August 13, 2020
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Antiplatelet Drugs
• Intracranial Aneurysm
• Stents
• Unruptured Intracranial Aneurysm

Intervention

Drug:
• Aspirin and clopidogrel/Ticagrelor
The modification of aspirin and clopidogrel/ticagrelor maintenance doses based on a biomarker assays.

Device:
• Light transmittance aggregometry
point-of-care method to assess platelet function by light transmittance aggregometry.

Drug:
• Aspirin and clopidogrel/Ticagrelor
maintenance dose of aspirin, clopidogrel and ticagrelor.

Locations

Country	Name	City	State
China	Beijing Neurosurgical Institute and Beijing Tiantan Hospital	Beijing	???

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Neurosurgical Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major bleeding and minor bleeding	Bleeding complications were accorded to Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria.	within 1 month of patients' enrolled.
Primary	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.	within 7 days of patients' enrolled.
Secondary	A thromboembolic event during the 1 month follow-up periods.		within 1 month of patients' enrolled.