Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF (NCT07609654) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF
852 participantsStarted 2026-06-01
Plain-language summary
This prospective, multicenter, randomized controlled trial aims to evaluate the efficacy and safety of initiating direct oral anticoagulants (DOACs) in patients with a history of spontaneous intracerebral hemorrhage (ICH) and non-valvular atrial fibrillation (AF) who have recently suffered an acute ischemic stroke. Existing evidence regarding the optimal antithrombotic strategy for this specific high-risk "double-jeopardy" population remains largely undefined. Eligible participants will be randomized in a 1:1 ratio to either receive oral anticoagulation therapy or a non-anticoagulation standard of care. The primary objective is to assess the incidence of a composite endpoint consisting of recurrent ischemic stroke and recurrent ICH over a 12-month follow-up period.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years.
. Diagnosis of acute ischemic stroke, with no evidence of hemorrhagic transformation confirmed by acute neuroimaging (MRI and CT).
. Documented history of spontaneous intracerebral hemorrhage (ICH).
. Provision of written informed consent by the patient or a legally authorized representative.
Exclusion criteria
. Severe baseline disability, defined as a pre-stroke Modified Rankin Scale (mRS) score \> 4.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of the Composite Endpoint of Recurrent Stroke
Timeframe: Up to 12 months
Trial details
NCT IDNCT07609654
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
. Intracerebral hemorrhage definitively caused by underlying structural vascular lesions (e.g., AVM, aneurysm) or systemic diseases.
. Severe, uncontrolled hypertension refractory to medical therapy.
. Severe renal impairment, defined as an estimated Creatinine Clearance (CrCl) \< 30 mL/min.
. Clinical indications necessitating continuous oral anticoagulation therapy other than atrial fibrillation (e.g., mechanical prosthetic heart valves, deep vein thrombosis, pulmonary embolism).
. Documented contraindications to direct oral anticoagulants according to the product summary of characteristics (excluding the previous spontaneous ICH), including but not limited to hypersensitivity, active clinically significant bleeding, high-risk bleeding lesions, or hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
. Prior deployment of, or planned procedure for, a left atrial appendage occlusion (LAAO) device.
. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period.