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

Primary Purpose

Intracranial Aneurysm, Stent Complication

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ticagrelor monotherapy
Dual Antiplatelet Therapy
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring Intracranial Aneurysm, Stent-Assisted Coiling, Ticagrelor, Dual Antiplatelet

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 18-45 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ticagrelor monotherapy group

    Dual Antiplatelet Therapy group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Hemorrhage
    The incidence of bleeding defined by Bleeding Academic Research Consortium
    Composite endpoint of all-cause mortality, cerebrovascular accident or urgent target vessel revascularization.
    Co-Primary Efficacy Endpoint (non-inferiority hypothesis)

    Secondary Outcome Measures

    ischemic stroke
    ischemic stroke or death during 1 year of follow-up in an intention-to treat analysis.
    Stent thrombosis
    Stent thrombosis
    BARC 1-5 type bleeding
    bleeding defined by Bleeding Academic Research Consortium

    Full Information

    First Posted
    August 23, 2023
    Last Updated
    August 23, 2023
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06015477
    Brief Title
    Stent-Assisted Coiling Followed by Ticagrelor Monotherapy Instead of Dual Antiplatelet Therapy in Unruptured Intracranial Aneurysm
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2025 (Anticipated)
    Study Completion Date
    July 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intracranial Aneurysm, Stent Complication
    Keywords
    Intracranial Aneurysm, Stent-Assisted Coiling, Ticagrelor, Dual Antiplatelet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ticagrelor monotherapy group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Dual Antiplatelet Therapy group
    Arm Type
    Active Comparator
    Arm Description
    Clopidogrel 75mg + Aspirin 100mg 1 month, after 1 month, change to aspirin 100mg 1 year.
    Intervention Type
    Drug
    Intervention Name(s)
    Ticagrelor monotherapy
    Intervention Description
    starting dose of ticagrelor was a single loading dose of 180mg (90mg x 2 tablets) and thereafter 1 tablet (90mg) each time, twice daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Dual Antiplatelet Therapy
    Intervention Description
    Clopidogrel 75mg + Aspirin 100mg 1 month, after 1 month, change to aspirin 100mg 1 year.
    Primary Outcome Measure Information:
    Title
    Hemorrhage
    Description
    The incidence of bleeding defined by Bleeding Academic Research Consortium
    Time Frame
    Within one year after surgery
    Title
    Composite endpoint of all-cause mortality, cerebrovascular accident or urgent target vessel revascularization.
    Description
    Co-Primary Efficacy Endpoint (non-inferiority hypothesis)
    Time Frame
    Within one year after surgery
    Secondary Outcome Measure Information:
    Title
    ischemic stroke
    Description
    ischemic stroke or death during 1 year of follow-up in an intention-to treat analysis.
    Time Frame
    This will be assessed during the first year of follow-up.
    Title
    Stent thrombosis
    Description
    Stent thrombosis
    Time Frame
    Within one year after surgery
    Title
    BARC 1-5 type bleeding
    Description
    bleeding defined by Bleeding Academic Research Consortium
    Time Frame
    Within one year after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 18-45 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hua Lu, Doctor
    Phone
    18761671021
    Email
    luhua@njmu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hua Lu, Doctor
    Organizational Affiliation
    The First Affiliated Hospital with Nanjing Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Individual participant data (IPD) will be available to other researchers under the approval of the ethical committee.
    IPD Sharing Time Frame
    the data will be available when summary data are published.
    Citations:
    PubMed Identifier
    20435198
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    29192856
    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.
    Results Reference
    result
    PubMed Identifier
    23826440
    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 Complications. J Vasc Interv Neurol. 2013 Jun;6(1):26-34.
    Results Reference
    result
    PubMed Identifier
    35143758
    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;:
    Results Reference
    result
    PubMed Identifier
    33602441
    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 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.
    Results Reference
    result
    PubMed Identifier
    33316640
    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.2020.11.038. Epub 2020 Dec 7.
    Results Reference
    result

    Learn more about this trial

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

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