COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03989557
Recruitment Status : Completed
First Posted : June 18, 2019
Last Update Posted : September 9, 2020
Information provided by (Responsible Party):
Beijing Neurosurgical Institute

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.

Condition or disease Intervention/treatment Phase
Unruptured Intracranial Aneurysm Stents Antiplatelet Drugs Drug: Aspirin and clopidogrel/Ticagrelor Device: Light transmittance aggregometry Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Platelet Function Test in the Application of Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : July 20, 2020
Actual Study Completion Date : August 13, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
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.

Experimental: Conventional Arm
Randomization: without light transmittance aggregometry, standard antiplatelet regimen was used for unruptured aneurysm patients with intracranial stent.
Drug: Aspirin and clopidogrel/Ticagrelor
maintenance dose of aspirin, clopidogrel and ticagrelor.

Primary Outcome Measures :
  1. A thromboembolic event during the early periprocedural period (within 7 days after stent placement) [ Time Frame: within 7 days of patients' enrolled. ]
    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 :
  1. A thromboembolic event during the 1 month follow-up periods. [ Time Frame: within 1 month of patients' enrolled. ]

Other Outcome Measures:
  1. Major bleeding and minor bleeding [ Time Frame: within 1 month of patients' enrolled. ]
    Bleeding complications were accorded to Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03989557

Layout table for location information
China, 北京市
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Beijing, 北京市, China, 100050
Sponsors and Collaborators
Beijing Neurosurgical Institute
Layout table for additonal information
Responsible Party: Beijing Neurosurgical Institute Identifier: NCT03989557    
Other Study ID Numbers: BNI-2019002
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Beijing Neurosurgical Institute:
Platelet function test
high platelet reactivity
light transmittance platelet aggregometry
Additional relevant MeSH terms:
Layout table for MeSH terms
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists