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

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ClinicalTrials.gov Identifier: NCT03989557
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : July 21, 2020
Sponsor:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 Stroke After Stent Placement in Intracranial Aneurysms
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : July 20, 2020
Estimated Study Completion Date : August 20, 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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03989557


Contacts
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Contact: Jian Liu, MD +86-010-67098852 jianliu_ns@163.com
Contact: Wenqiang Li, PHD +86-010-67098852 lwqsurgeon@163.com

Locations
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China, 北京市
Beijing Neurosurgical Institute and Beijing Tiantan Hospital Recruiting
Beijing, 北京市, China, 100050
Contact: Jian Liu, MD    01067098852    jianliu_ns@163.com   
Sponsors and Collaborators
Beijing Neurosurgical Institute
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Responsible Party: Beijing Neurosurgical Institute
ClinicalTrials.gov Identifier: NCT03989557    
Other Study ID Numbers: BNI-2019002
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Aspirin
Clopidogrel
Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists