Using Ticagrelor instead of Dual Antiplatelet Therapy for treating unruptured intracranial aneurysms
Stent-Assisted Coiling Followed by Ticagrelor Monotherapy Instead of Dual Antiplatelet Therapy in Endovascular Treatment of Unruptured Intracranial Aneurysm (SAC-TIDE) ---a Pilot Study
This study is testing if using Ticagrelor alone instead of two blood-thinning medications can help adults with unruptured brain aneurysms have fewer bleeding problems after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06015477 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of Ticagrelor monotherapy compared to dual antiplatelet therapy in reducing bleeding complications for patients undergoing stent-assisted coiling for unruptured intracranial aneurysms. The study aims to determine if Ticagrelor, a P2Y12 inhibitor, can maintain ischemic protection while minimizing the risk of major bleeding. Participants will include adults aged 18-60 with specific eligibility criteria, and the trial will assess both safety and efficacy outcomes. The goal is to improve post-procedural management of patients with intracranial aneurysms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with unruptured intracranial aneurysms less than 10 mm who have undergone stent-assisted coiling without perioperative complications.
Not a fit: Patients with a history of chronic diseases or those requiring anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce bleeding complications for patients undergoing treatment for unruptured intracranial aneurysms.
How similar studies have performed: Previous studies have indicated that P2Y12 inhibitor monotherapy may effectively reduce bleeding risks without increasing ischemic events, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nanjing, Jiangsu
- Hua Lu — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Hua Lu, Doctor
- Email: luhua@njmu.edu.cn
- Phone: 18761671021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.