Stent-Assisted Coiling Followed by Ticagrelor Monotherapy Instead of Dual Antiplatelet Therapy in Unruptured Intracranial Aneurysm

Intracranial Aneurysm Clinical Trial

— SAC-TIDE  

Official title:

Stent-Assisted Coiling Followed by Ticagrelor Monotherapy Instead of Dual Antiplatelet Therapy in Endovascular Treatment of Unruptured Intracranial Aneurysm (SAC-TIDE) ---a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015477
• Other study ID #: SAC-TIDE
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: March 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Hua Lu, Doctor
• Phone: 18761671021
• Email: luhua[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary goal of the trial is to investigate whether the experimental arms (receiving the P2Y12 inhibitor Ticagrelor) compared with the control arm (taking dual antiplatelet therapy) could reduce bleeding complications in patients with intracranial aneurysms undergoing Stent-Assisted Coiling.

Description:

Bleeding complications associated with the use of DAPT have been of great concern, with up to one-third of PCI patients treated with DAPT previously reported to suffer from nuisance bleeding. Once any of these bleeding complications occur, adherence to the DAPT regimen may become difficult. Antiplatelet agents are necessary for patients undergoing stent-assisted spring coil embolisation of intracranial aneurysms and are key to reducing thrombosis leading to ischaemic stroke events in post-procedural patients.

Currently neither long-term DAPT nor short-duration DAPT followed by aspirin monotherapy is fully satisfactory. Patients with aneurysms without underlying intracranial atherosclerotic disease have relatively lower ischaemic risk factors, and antiplatelet medication after stenting remains to be improved. Ticagrelor monotherapy was associated with a lower risk of major bleeding and no measurable increase in ischaemic events after a short course of 1- or 3-month DAPT. The study indicated no difference in stroke or death between mono- and dual-antiplatelet therapy after carotid artery placement, and P2Y12 inhibitor monotherapy may be an effective strategy to reduce severe bleeding complications while preserving ischemic benefits for patients. This study investigates the comparative efficacy and safety of stent-assisted coiling therapy for intracranial aneurysms after ticagrelor monotherapy as an alternative to dual antiplatelet therapy, to reduce the incidence of bleeding complications in patients, and thus to improve the antiplatelet strategy after stent-assisted coiling therapy for intracranial aneurysms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patients with a definitive diagnosis of an unruptured intracranial aneurysm with imaging suggestive of an aneurysm <10 mm

2. Patients who successfully underwent stent-assisted spring coil treatment for intracranial aneurysms without acute ischaemic or bleeding stroke events in the perioperative period

3. Age 18-60 years old

4. Patients with no previous history of chronic diseases such as hypertension, diabetes mellitus, coronary heart disease, hyperlipidaemia and so on

5. Agreed to participate in this study and gave informed consent for the collection and preservation of case data and the follow-up process.

Exclusion Criteria:

1. Planned surgery or intervention during the experiment requiring study drug discontinuation; (2) Contraindications requiring oral anticoagulation or aspirin or clopidogrel; (3) History of severe central nervous system damage (e.g., as a result of tumour, aneurysm, intracranial or spinal cord surgery); (4) Severe liver disease, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices), active hepatitis; (5 ) severe renal dysfunction (creatinine more than 1.5 times the upper limit of the normal range); (6) severe heart failure (NYHA class:III ~ IV); high risk for chronic arrhythmias (1st or 2nd degree atrioventricular block due to sinus node disease, bradycardic syncope without pacemaker); diagnosis or suspected diagnosis of acute coronary syndrome; bacterial endocarditis, pericarditis; (7) severe comorbidities or patients with active cancer with a life expectancy of less than 2 years; (8) participation in another clinical study using an experimental product within the past 30 days; currently receiving an experimental drug or device; and (9) pregnant, currently pregnant, or of childbearing potential without birth control or breastfeeding.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Stent Complication

Intervention

Drug:
• Ticagrelor monotherapy
starting dose of ticagrelor was a single loading dose of 180mg (90mg x 2 tablets) and thereafter 1 tablet (90mg) each time, twice daily.
• Dual Antiplatelet Therapy
Clopidogrel 75mg + Aspirin 100mg 1 month, after 1 month, change to aspirin 100mg 1 year.

Locations

Country	Name	City	State
China	Hua Lu	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

Ben-Dor I, Torguson R, Scheinowitz M, Li Y, Delhaye C, Wakabayashi K, Maluenda G, Syed AI, Collins SD, Gonzalez MA, Gaglia MA Jr, Xue Z, Kaneshige K, Satler LF, Suddath WO, Kent KM, Pichard AD, Waksman R. Incidence, correlates, and clinical impact of nuis — View Citation

Gutierrez J, Turan TN, Hoh BL, Chimowitz MI. Intracranial atherosclerotic stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2022 Apr;21(4):355-368. doi: 10.1016/S1474-4422(21)00376-8. Epub 2022 Feb 7. Erratum In: Lancet Neurol. 2022 Feb 16; — View Citation

Jin Y, Huang H, Shu X, Chen S, Lu L, Gao X, Wu Z. P2Y12 inhibitor monotherapy and dual antiplatelet therapy after percutaneous coronary intervention: An updated meta-analysis of randomized trials. Thromb Res. 2021 Feb;198:115-121. doi: 10.1016/j.thromres. — View Citation

Kim KS, Fraser JF, Grupke S, Cook AM. Management of antiplatelet therapy in patients undergoing neuroendovascular procedures. J Neurosurg. 2018 Oct;129(4):890-905. doi: 10.3171/2017.5.JNS162307. Epub 2017 Dec 1. — View Citation

Nordeen JD, Patel AV, Darracott RM, Johns GS, Taussky P, Tawk RG, Miller DA, Freeman WD, Hanel RA. Clopidogrel Resistance by P2Y12 Platelet Function Testing in Patients Undergoing Neuroendovascular Procedures: Incidence of Ischemic and Hemorrhagic Complic — View Citation

Valgimigli M, Mehran R, Franzone A, da Costa BR, Baber U, Piccolo R, McFadden EP, Vranckx P, Angiolillo DJ, Leonardi S, Cao D, Dangas GD, Mehta SR, Serruys PW, Gibson CM, Steg GP, Sharma SK, Hamm C, Shlofmitz R, Liebetrau C, Briguori C, Janssens L, Huber — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemorrhage	The incidence of bleeding defined by Bleeding Academic Research Consortium	Within one year after surgery
Primary	Composite endpoint of all-cause mortality, cerebrovascular accident or urgent target vessel revascularization.	Co-Primary Efficacy Endpoint (non-inferiority hypothesis)	Within one year after surgery
Secondary	ischemic stroke	ischemic stroke or death during 1 year of follow-up in an intention-to treat analysis.	This will be assessed during the first year of follow-up.
Secondary	Stent thrombosis	Stent thrombosis	Within one year after surgery
Secondary	BARC 1-5 type bleeding	bleeding defined by Bleeding Academic Research Consortium	Within one year after surgery