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Intracranial AneurysmGATITIANCT05825391

Guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms

A study testing Adjustment of Antiplatelet Drugs in people with Intracranial Aneurysm, run by Beijing Tiantan Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Intracranial Aneurysm
What is being tested?
Adjustment of Antiplatelet Drugs
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
590 participants
Where
2 sitesChina
Study dates
4 May 2023to 29 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Tiantan hospital

    Beijing, Beijing Municipality, 100070

  • Department of Neurosurgery, Beijing Tiantan Hospital.

    Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: 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.

Being tested
Adjustment of Antiplatelet Drugs
Keywords
Intracranial Aneurysm, Interventional Therapy, Stent, Platelet, Ischemic Stroke, Bleeding Event
Medical subject headings
Intracranial Aneurysm, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjustment of Antiplatelet DrugsDrug

    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.

Study groups in NCT05825391
Study groupRoleWhat they receive
control groupNo interventionContinue to use the center's original antiplatelet regimen: oral aspirin 100 mg and clopidogrel 75 mg daily
test groupExperimentalUse a guided antiplatelet regimen based on LTA testing
Receives: Drug: Adjustment of Antiplatelet Drugs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ischemic events

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

    Measured: 30 days after stent implantation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2023
  2. Study start4 May 2023
  3. Primary completion3 Oct 2023
  4. Study completion29 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
cluster randomized controlled cohort study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
590 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05825391
Sponsor's protocol ID
Xinjian Yang
Acronym
GATITIA
Status last verified
Nov 2023
First submitted
11 Apr 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou Y, Li W, Wang C, Xie R, Zhu Y, Peng Q, Zhang L, Zhang H, Gu Y, Mu S, Liu J, Yang X. Roles of light transmission aggregometry and CYP2C19 genotype in predicting ischaemic complications during interventional therapy for intracranial aneurysms. Stroke Vasc Neurol. 2023 Aug;8(4):327-334. doi: 10.1136/svn-2022-001720. Epub 2023 Feb 6.

    PubMed 36746550

  • GUSTO investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993 Sep 2;329(10):673-82. doi: 10.1056/NEJM199309023291001.

    PubMed 8204123

  • Easton JD, Saver JL, Albers GW, Alberts MJ, Chaturvedi S, Feldmann E, Hatsukami TS, Higashida RT, Johnston SC, Kidwell CS, Lutsep HL, Miller E, Sacco RL; American Heart Association; American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Interdisciplinary Council on Peripheral Vascular Disease. Definition and evaluation of transient ischemic attack: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; and the Interdisciplinary Council on Peripheral Vascular Disease. The American Academy of Neurology affirms the value of this statement as an educational tool for neurologists. Stroke. 2009 Jun;40(6):2276-93. doi: 10.1161/STROKEAHA.108.192218. Epub 2009 May 7.

    PubMed 19423857

  • Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.

    PubMed 23652265

  • Gulliford MC, Adams G, Ukoumunne OC, Latinovic R, Chinn S, Campbell MJ. Intraclass correlation coefficient and outcome prevalence are associated in clustered binary data. J Clin Epidemiol. 2005 Mar;58(3):246-51. doi: 10.1016/j.jclinepi.2004.08.012.

    PubMed 15718113

  • Zhou Y, Wang J, Li W, Liu J, Wang A, Zhang Y, Mu S, Xie R, Peng Q, Zhang L, Luo B, Zhao Y, Wang Y, Zhang Z, Lin Y, Zhang P, Zhang J, Li L, Yin X, Xiao F, Lin Y, Liu X, Bian Y, Wang S, Li J, Zhang X, Hasan DM, Krings T, Zhang H, Yang X. Guided Antiplatelet Therapy for Stent-Treated Intracranial Aneurysms: A Cluster-Randomized Trial. Radiology. 2025 Mar;314(3):e241509. doi: 10.1148/radiol.241509.

    PubMed 40100020

Questions about this trial

What is this clinical trial studying?

A study testing Adjustment of Antiplatelet Drugs in people with Intracranial Aneurysm, run by Beijing Tiantan Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ischemic events (time frame: 30 days after stent implantation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05825391, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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