Guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms (GATITIA)

November 15, 2023 updated by: Beijing Tiantan Hospital

Guided Versus Standard Antiplatelet Therapy in Intracranial Aneurysm Intervention With Stents: a Cluster Randomized Controlled Cohort Study

The use of intracranial stents expands the possibilities for endovascular treatment of intracranial aneurysms and improves the success rate. However, it also increases the risk of ischemic complications in patients. The current standard dual antiplatelet regimen is considered crucial in reducing thrombotic events. Nevertheless, some patients exhibit resistance to antiplatelet drugs, which puts them at a higher risk of thrombotic events. In clinical practice, there is a lack of standardized platelet function testing and consensus on adjusting antiplatelet drug programs. This study conducted a multi-center, prospective cluster randomized controlled trial to investigate whether antiplatelet adjustment therapy guided by light transmittance aggregometry (LTA) detection can decrease the occurrence of ischemic events after stent implantation in patients with unruptured intracranial aneurysms. Additionally, the study aimed to establish a set of standardized antiplatelet regimens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

590

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Beijing Tiantan Hospital
      • Beijing, Beijing, China, 100070
        • Department of Neurosurgery, Beijing Tiantan Hospital.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with unruptured intracranial aneurysms who received intracranial stenting,
  2. Standard dualantiplatelet therapy for at least 5 days before stent implantation,
  3. Patients aged 18-80,
  4. on the day of registration patients with a Modified Rankin Scale lower than 2,
  5. patients who agree and sign the consent form.

Exclusion Criteria:

  1. Patients with recurrent aneurysms after interventional therapy or clipping therapy,
  2. Patients with a history of allergy to aspirin, clopidogrel or ticagrelor,
  3. Patients who used tirofiban prophylactically before surgery,
  4. 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,
  5. Any abnormal platelet count (normal value is 100-300 × 10^9/L),
  6. Patients using anticoagulants,
  7. Pregnant or lactating women,
  8. Suffering from liver disease, kidney disease, congestive heart failure, malignant tumors and other malignant diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Continue to use the center's original antiplatelet regimen: oral aspirin 100 mg and clopidogrel 75 mg daily
Experimental: test group
Use a guided antiplatelet regimen based on LTA testing
Drug: Adjustment of Antiplatelet Drugs
The maximum platelet aggregation rate induced by arachidonic acid (AA-MPA)≥20%, give aspirin 200mg qd. The maximum platelet aggregation rate induced by adenosine diphosphatase (ADP-MPA)≥36.4% for flow diversion, give ticagrelor 60mg bid. ADP-MPA≥42.9% for stent-assisted coil embolization，give ticagrelor 60mg bid. ADP-MPA<20%, give clopidogrel 37.5mg qd. The timing of drug adjustment should be at least 1 day before stent implantation, and the LTA testing should be performed again 48 hours after the drug adjustment. For patients whose ADP-MPA does not reach the normal range, a second antiplatelet drug adjustment should be performed: ticagrelor overdose: reduce to 45mg bid; ticagrelor resistance, increase to 90 mg bid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic events
Time Frame: 30 days after stent implantation.
ischemic stroke, transient ischemic stroke (TIA), stent thrombosis
30 days after stent implantation.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding events
Time Frame: 30 days after stent implantation.
The primary safety endpoint was severe or life-threatening bleeding, moderate bleeding and minor bleeding, assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) classification.
30 days after stent implantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Collaborators

Peking University First Hospital
Chinese PLA General Hospital
Xuanwu Hospital, Beijing
Peking University International Hospital
Beijing Chao Yang Hospital
Tianjin Medical University General Hospital
Hebei Medical University Third Hospital

Investigators

  • Principal Investigator: Xinjian Yang, MD, Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2023

Primary Completion (Actual)

October 3, 2023

Study Completion (Actual)

October 29, 2023

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 21, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xinjian Yang

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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