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

Beijing Neurosurgical Institute

Status and phase: Completed; Phase 4

Conditions: Antiplatelet Drugs; Stents; Unruptured Intracranial Aneurysm

Treatments: Device: Light transmittance aggregometry; Drug: Aspirin and clopidogrel/Ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT03989557

BNI-2019002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 314 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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314 participants in 2 patient groups

Monitoring Arm

Experimental group

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.

Treatment:

Device: Light transmittance aggregometry

Drug: Aspirin and clopidogrel/Ticagrelor

Drug: Aspirin and clopidogrel/Ticagrelor

Conventional Arm

Experimental group

Description:

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

Treatment:

Drug: Aspirin and clopidogrel/Ticagrelor

Drug: Aspirin and clopidogrel/Ticagrelor