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Completed

NCT Number: NCT05825391

Guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms

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.

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with unruptured intracranial aneurysms who received intracranial stenting,
  • Standard dualantiplatelet therapy for at least 5 days before stent implantation,
  • Patients aged 18-80,
  • on the day of registration patients with a Modified Rankin Scale 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 tirofiban 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.

Treatment and study plan

Adjustment of Antiplatelet Drugs

Drug

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.

Primary outcomes

  1. Ischemic events

    Time frame: 30 days after stent implantation.

    ischemic stroke, transient ischemic stroke (TIA), stent thrombosis

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: GATITIA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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