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

NCT03989557 | Completed Phase 4 DMC

• 1 other identifier: BNI-2019002
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Unruptured Intracranial Aneurysm; Stents; Antiplatelet Drugs

Keywords

Platelet function test; high platelet reactivity; light transmittance platelet aggregometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  within 1 month of patients' enrolled.

Other Outcomes (1)

• Major bleeding and minor bleeding

  within 1 month of patients' enrolled.

Study Arms (2)

Monitoring Arm

EXPERIMENTAL

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.

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

Conventional Arm

EXPERIMENTAL

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

Drug: Aspirin and clopidogrel/Ticagrelor

Interventions

Aspirin and clopidogrel/Ticagrelor DRUG

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

Monitoring Arm

Light transmittance aggregometry DEVICE

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

Monitoring Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Neurosurgical Institute: lead

Study Sites (1)

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

• 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.

  PMID: 34538087 DERIVED

MeSH Terms

Interventions

Aspirin; Clopidogrel; Ticagrelor

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2019
• First Posted: June 18, 2019
• Study Start: July 1, 2019
• Primary Completion: July 20, 2020
• Study Completion: August 13, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)