search
Back to results

LTA-guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms

Primary Purpose

Intracranial Aneurysm

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Adjustment of Antiplatelet Drugs
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intracranial Aneurysm focused on measuring Intracranial Aneurysm, Interventional Therapy, Stent, Platelet, Ischemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with unruptured intracranial aneurysms who received intracranial stenting, Standard dual-antibody therapy for at least 5 days before stent implantation, Patients aged 18-80, on the day of registration patients with a Modified Rankin Score lower than 2, patients who agree and sign the consent form. Exclusion Criteria: Patients with recurrent aneurysms after interventional therapy or clipping therapy, Patients with a history of allergy to aspirin, clopidogrel or ticagrelor, Patients who used tilofiban prophylactically before surgery, Possible active bleeding Patients with high blood pressure, such as symptomatic intracranial hemorrhage or active gastric ulcer; or patients with bleeding tendency or coagulation dysfunction, Any abnormal platelet count (normal value is 100-300 × 10^9/L), Patients using Anticoagulants, Pregnant or lactating women, Suffering from liver disease, kidney disease, congestive heart failure, malignant tumors and other malignant diseases.

Sites / Locations

  • Beijing Tiantan hospitalRecruiting
  • Department of Neurosurgery, Beijing Tiantan Hospital.

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

test group

Arm Description

Continue to use the center's original antiplatelet regimen

Use a standardized antiplatelet drug adjustment regimen based on LTA testing

Outcomes

Primary Outcome Measures

Ischemic events
ischemic stroke, TIA, stent thrombosis

Secondary Outcome Measures

Full Information

First Posted
April 11, 2023
Last Updated
July 5, 2023
Sponsor
Beijing Tiantan Hospital
Collaborators
Xuanwu Hospital, Beijing, Chinese PLA General Hospital, Beijing Chao Yang Hospital, Peking University International Hospital, Peking University First Hospital, Hebei Medical University Third Hospital, Tianjin Medical University General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05825391
Brief Title
LTA-guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms
Official Title
Standardization of Antiplatelet Therapy in Intracranial Aneurysm Intervention With Stents: a Cluster Randomized Controlled Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Xuanwu Hospital, Beijing, Chinese PLA General Hospital, Beijing Chao Yang Hospital, Peking University International Hospital, Peking University First Hospital, Hebei Medical University Third Hospital, Tianjin Medical University General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The use of intracranial stents broadens the indications for endovascular treatment of intracranial aneurysms and improves the cure rate, but it also increases the risk of postoperative ischemic complications in patients. The current standard dual antiplatelet regimen is considered to be an important method to reduce thrombotic events. However, some patients are resistant to antiplatelet drugs and have a high risk of thrombotic events. In actual clinical work, the standards for platelet function testing are not standardized, and the antiplatelet drug adjustment program also lacks norms and consensus. This study carried out a multi-center, prospective cluster randomized controlled study to explore whether the standardized antiplatelet adjustment program guided by LTA detection can reduce the incidence of ischemic events after stent implantation in patients with intracranial unruptured aneurysms. Further determine and correct the curative effect of the standardized use of antiplatelet drugs in the treatment of intracranial aneurysm stents, and finally formulate a set of standardized antiplatelet regimens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
Keywords
Intracranial Aneurysm, Interventional Therapy, Stent, Platelet, Ischemic Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
cluster randomized controlled cohort study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
590 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Continue to use the center's original antiplatelet regimen
Arm Title
test group
Arm Type
Experimental
Arm Description
Use a standardized antiplatelet drug adjustment regimen based on LTA testing
Intervention Type
Drug
Intervention Name(s)
Adjustment of Antiplatelet Drugs
Intervention Description
MPA-AA≥20%, give aspirin 200mg qd; MPA-ADP≥36.4%, give ticagrelor 60mg bid; MPA-ADP≥42.9%, give ticagrelor 60mg bid; MPA-ADP<20%, give Clopidogrel 37.5mg qd; The timing of drug adjustment should be at least 1 day before stent implantation, and the LTA results should be checked again after the drug adjustment, and the second antiplatelet drug adjustment should be performed for patients with drug overdose: *Aspirin overdose: Give 100mg, qd; *Ticagrelor overdose: reduce to 45mg, bid;.
Primary Outcome Measure Information:
Title
Ischemic events
Description
ischemic stroke, TIA, stent thrombosis
Time Frame
30 days after stent implantation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with unruptured intracranial aneurysms who received intracranial stenting, Standard dual-antibody therapy for at least 5 days before stent implantation, Patients aged 18-80, on the day of registration patients with a Modified Rankin Score lower than 2, patients who agree and sign the consent form. Exclusion Criteria: Patients with recurrent aneurysms after interventional therapy or clipping therapy, Patients with a history of allergy to aspirin, clopidogrel or ticagrelor, Patients who used tilofiban prophylactically before surgery, Possible active bleeding Patients with high blood pressure, such as symptomatic intracranial hemorrhage or active gastric ulcer; or patients with bleeding tendency or coagulation dysfunction, Any abnormal platelet count (normal value is 100-300 × 10^9/L), Patients using Anticoagulants, Pregnant or lactating women, Suffering from liver disease, kidney disease, congestive heart failure, malignant tumors and other malignant diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yangyang Zhou, MD
Phone
19801205494
Email
19801205494@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinjian Yang, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yangyang Zhou, MD
Phone
19801205494
Email
yangxinjian@voiceoftiantan.org
Facility Name
Department of Neurosurgery, Beijing Tiantan Hospital.
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yangyang Zhou, MD
Phone
19801205494
Email
19801205494@163.com

12. IPD Sharing Statement

Learn more about this trial

LTA-guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms

We'll reach out to this number within 24 hrs