Intracranial Aneurysm Clinical Trial
— SAC-TIDEOfficial 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
NCT number | NCT06015477 |
Other study ID # | SAC-TIDE |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2024 |
Est. completion date | July 1, 2025 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Hua Lu | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
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
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 |
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