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

NCT06015477 | Recruiting DMC

• 1 other identifier: SAC-TIDE
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracranial Aneurysm; Stent Complication

Keywords

Intracranial Aneurysm; Stent-Assisted Coiling; Ticagrelor; Dual Antiplatelet

Outcome Measures

Primary Outcomes (2)

• Hemorrhage

  The incidence of bleeding defined by Bleeding Academic Research Consortium

  Within one year after surgery

• 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 Outcomes (3)

• ischemic stroke

  This will be assessed during the first year of follow-up.

• Stent thrombosis

  Within one year after surgery

• BARC 1-5 type bleeding

  Within one year after surgery

Study Arms (2)

ticagrelor monotherapy group

EXPERIMENTAL

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.). After 1 month, continuation to ticagrelor monotherapy for 1 year.

Drug: Ticagrelor monotherapy

Dual Antiplatelet Therapy group

ACTIVE COMPARATOR

Clopidogrel 75mg + Aspirin 100mg 1 month, after 1 month, change to aspirin 100mg 1 year.

Drug: Dual Antiplatelet Therapy

Interventions

Ticagrelor monotherapy DRUG

starting dose of ticagrelor was a single loading dose of 180mg (90mg x 2 tablets) and thereafter 1 tablet (90mg) each time, twice daily.

ticagrelor monotherapy group

Dual Antiplatelet Therapy DRUG

Clopidogrel 75mg + Aspirin 100mg 1 month, after 1 month, change to aspirin 100mg 1 year.

Dual Antiplatelet Therapy group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a definitive diagnosis of an unruptured intracranial aneurysm with imaging suggestive of an aneurysm \<10 mm
• Patients who successfully underwent stent-assisted spring coil treatment for intracranial aneurysms without acute ischaemic or bleeding stroke events in the perioperative period
• Age 18-60 years old
• Patients with no previous history of chronic diseases such as hypertension, diabetes mellitus, coronary heart disease, hyperlipidaemia and so on
• Agreed to participate in this study and gave informed consent for the collection and preservation of case data and the follow-up process.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Hua Lu

Nanjing, Jiangsu, China

RECRUITING

Related 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 nuisance bleeding after antiplatelet therapy for patients with drug-eluting stents. Am Heart J. 2010 May;159(5):871-5. doi: 10.1016/j.ahj.2010.01.016.

  PMID: 20435198 RESULT

• 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.

  PMID: 29192856 RESULT

• 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 Complications. J Vasc Interv Neurol. 2013 Jun;6(1):26-34.

  PMID: 23826440 RESULT

• 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.

  PMID: 35143758 RESULT

• 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 K, Ferrario M, Kunadian V, Cohen DJ, Zurakowski A, Oldroyd KG, Yaling H, Dudek D, Sartori S, Kirkham B, Escaned J, Heg D, Windecker S, Pocock S, Juni P; SIDNEY Collaboration. Ticagrelor Monotherapy Versus Dual-Antiplatelet Therapy After PCI: An Individual Patient-Level Meta-Analysis. JACC Cardiovasc Interv. 2021 Feb 22;14(4):444-456. doi: 10.1016/j.jcin.2020.11.046.

  PMID: 33602441 RESULT

• 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.2020.11.038. Epub 2020 Dec 7.

  PMID: 33316640 RESULT

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Study Officials

• Hua Lu, Doctor

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Hua Lu, Doctor

CONTACT

18761671021; luhua@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients meeting the enrollment criteria will be randomly assigned to one of the two treatment groups (1:1) and will be followed up for 1 year. All patients received oral clopidogrel 75 mg + aspirin 100 mg for 3-5 days preoperatively.

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: January 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: the data will be available when summary data are published.

Locations

CN (1)