Intracranial AneurysmSAC-TIDENCT06015477
Stent-Assisted Coiling Followed by Ticagrelor Monotherapy Instead of Dual Antiplatelet Therapy in Unruptured Intracranial Aneurysm
A study testing Ticagrelor monotherapy and Dual Antiplatelet Therapy in people with Intracranial Aneurysm and Stent Complication, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracranial Aneurysm, Stent Complication
- What is being tested?
- Ticagrelor monotherapy and Dual Antiplatelet Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hua Lu
Nanjing, Jiangsu
Hua Lu, DR, luhua@njmu.edu.cn, luhua@njmu.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Intracranial Aneurysm, Stent Complication
- Being tested
- Ticagrelor monotherapy, Dual Antiplatelet Therapy
- Keywords
- Intracranial Aneurysm, Stent-Assisted Coiling, Ticagrelor, Dual Antiplatelet
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor monotherapyDrug
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 TherapyDrug
Clopidogrel 75mg + Aspirin 100mg 1 month, after 1 month, change to aspirin 100mg 1 year.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ticagrelor monotherapy |
| Dual Antiplatelet Therapy group | Active comparator | Clopidogrel 75mg + Aspirin 100mg 1 month, after 1 month, change to aspirin 100mg 1 year. Receives: Drug: Dual Antiplatelet Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorrhage
The incidence of bleeding defined by Bleeding Academic Research Consortium
Measured: 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)
Measured: Within one year after surgery
Secondary outcomes (3)
ischemic stroke
ischemic stroke or death during 1 year of follow-up in an intention-to treat analysis.
Measured: This will be assessed during the first year of follow-up.
Stent thrombosis
Stent thrombosis
Measured: Within one year after surgery
BARC 1-5 type bleeding
bleeding defined by Bleeding Academic Research Consortium
Measured: Within one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Jan 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hua Lu, Doctor, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015477
- Sponsor's protocol ID
- SAC-TIDE
- Acronym
- SAC-TIDE
- Status last verified
- Mar 2024
- First submitted
- 23 Aug 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be available to other researchers under the approval of the ethical committee.
Publications
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.
PubMed 20435198Kim 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.
PubMed 29192856Nordeen 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.
PubMed 23826440Gutierrez 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.
PubMed 35143758Valgimigli 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.
PubMed 33602441Jin 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.
PubMed 33316640
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06015477
- Acronym / sponsor ID
- SAC-TIDE / SAC-TIDE
- Conditions
- Intracranial Aneurysm, Stent Complication
- Keywords
- Intracranial Aneurysm, Stent-Assisted Coiling, Ticagrelor, Dual Antiplatelet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ticagrelor monotherapy group | Experimental | Drug: Ticagrelor monotherapyTicagrelor 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. |
| Dual Antiplatelet Therapy group | Active comparator | Drug: Dual Antiplatelet TherapyClopidogrel 75mg + Aspirin 100mg 1 month, after 1 month, change to aspirin 100mg 1 year. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor monotherapystarting dose of ticagrelor was a single loading dose of 180mg (90mg x 2 tablets) and thereafter 1 tablet (90mg) each time, twice daily. | Drug | ticagrelor monotherapy group |
| Dual Antiplatelet TherapyClopidogrel 75mg + Aspirin 100mg 1 month, after 1 month, change to aspirin 100mg 1 year. | Drug | Dual Antiplatelet Therapy group |
Primary outcome
Hemorrhage
Time frame: Within one year after surgery
The incidence of bleeding defined by Bleeding Academic Research Consortium
Composite endpoint of all-cause mortality, cerebrovascular accident or urgent target vessel revascularization.
Time frame: Within one year after surgery
Co-Primary Efficacy Endpoint (non-inferiority hypothesis)
3 secondary outcomes
ischemic stroke
Time frame: This will be assessed during the first year of follow-up.
Stent thrombosis
Time frame: Within one year after surgery
BARC 1-5 type bleeding
Time frame: Within one year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Results publication: PubMed 20435198Ben-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 publication: PubMed 29192856Kim 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 publication: PubMed 23826440Nordeen 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 publication: PubMed 35143758Gutierrez 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.
- Results publication: PubMed 33602441Valgimigli 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 publication: PubMed 33316640Jin 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be available to other researchers under the approval of the ethical committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hua Lu, Doctor study chair
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ticagrelor monotherapy and Dual Antiplatelet Therapy in people with Intracranial Aneurysm and Stent Complication, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Lu, Doctor (18761671021, luhua@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemorrhage (time frame: Within one year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06015477, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.