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

NCT ID: NCT03989557

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-08-13

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.

Conditions

Unruptured Intracranial Aneurysm; Stents; Antiplatelet Drugs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Monitoring Arm

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.

Group Type: EXPERIMENTAL

Aspirin and clopidogrel/Ticagrelor

Intervention Type: DRUG

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

Light transmittance aggregometry

Intervention Type: DEVICE

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

Aspirin and clopidogrel/Ticagrelor

Intervention Type: DRUG

maintenance dose of aspirin, clopidogrel and ticagrelor.

Conventional Arm

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

Group Type: EXPERIMENTAL

Aspirin and clopidogrel/Ticagrelor

Intervention Type: DRUG

maintenance dose of aspirin, clopidogrel and ticagrelor.

Interventions

Aspirin and clopidogrel/Ticagrelor

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

Intervention Type: DRUG

Light transmittance aggregometry

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

Intervention Type: DEVICE

Aspirin and clopidogrel/Ticagrelor

maintenance dose of aspirin, clopidogrel and ticagrelor.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Neurosurgical Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34538087 (View on PubMed)

Other Identifiers

BNI-2019002

Identifier Type: -

Identifier Source: org_study_id