Guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms

Intracranial Aneurysm Clinical Trial

— GATITIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05825391
• Other study ID #: Xinjian Yang
• Status: Completed
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: October 29, 2023

Study information

• Verified date: November 2023
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 590
• Est. completion date: October 29, 2023
• Est. primary completion date: October 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Tiantan hospital	Beijing	Beijing
China	Department of Neurosurgery, Beijing Tiantan Hospital.	Beijing	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	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

Country where clinical trial is conducted

China, 

References & Publications (5)

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 Sur — View Citation

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. — View Citation

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. — View Citation

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 Associatio — View Citation

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 V — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bleeding events	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.
Primary	Ischemic events	ischemic stroke, transient ischemic stroke (TIA), stent thrombosis	30 days after stent implantation.