Thrombolytic therapy for stroke patients on blood thinners
Intravenous Thrombolytic Therapy in Acute Ischemic Stroke Patients on Direct Oral Anticoagulants - A Prospective Multicenter Study
This study is testing if a specific stroke treatment can be safely used in patients who were on blood thinners before their stroke to see if it helps them recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06241677 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of intravenous thrombolytic therapy (IVT) in patients experiencing acute ischemic stroke while on direct oral anticoagulants (DOACs). It aims to recruit patients who have taken DOACs within 12-48 hours prior to their stroke and assess their neurological outcomes after receiving IVT. The study will compare these patients to a matched cohort who did not receive IVT to determine if IVT can be safely administered without increasing the risk of intracerebral bleeding. The research is being conducted at the Chinese University of Hong Kong and several collaborating hospitals.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced an acute ischemic stroke while on DOACs within the specified time frame.
Not a fit: Patients with contraindications to thrombolytic therapy or those with significant bleeding risks unrelated to DOAC use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for stroke patients on DOACs, potentially improving their recovery outcomes.
How similar studies have performed: While there is limited evidence on this specific approach, the study addresses a significant clinical dilemma that has not been extensively tested in prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Acute ischemic stroke patients with a last-known-well to presentation time within 4.5 hours 2. Patients who took any doses of apixaban (2.5mg or 5mg twice daily), dabigatran (110mg or 150mg twice daily), edoxaban (30mg or 60mg daily) or rivaroxaban (15mg or 20mg daily) 12-48 hours before presentation 3. National Institute of Health Stroke Scale (NIHSS) ≥ 3 4. Alberta Stroke Programme Early CT (ASPECT) score ≥ 6 5. Pre-morbid modified Rankin Scale (mRS) ≤ 3 6. Patients aged ≥ 18 years old Exclusion Criteria: 1. Initial CT brain showing intracranial haemorrhage 2. Contraindications to IVT according to current guideline recommendations \[5\], except for the use of DOAC within 12-48 hours 3. Patients with an estimated glomerular filtration rate of ≤ 30ml/min/1.73m2 4. Patients with bleeding propensities apart from the use of DOAC, e.g. platelet count of \< 100x109/L 5. Patients with significant head injury immediately prior to presentation
Where this trial is running
Hong Kong
- Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Bonaventure Yiu Ming Ip, MB ChB — Chinese University of Hong Kong
- Study coordinator: Yiu Ming Bonaventure Ip, MB ChB
- Email: bonaventureip@cuhk.edu.hk
- Phone: +852-26352152
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.