Evaluating the safety and effectiveness of thrombolysis in stroke patients on blood thinners
Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke on Treatment With Direct Oral Anticoagulants: DO-IT - The DOAC Intravenous Thrombolysis Trial
This study is testing if giving a specific treatment for stroke along with regular care can help people who have taken blood thinners feel better after a stroke.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 906 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 14 sites (Leuven and 13 other locations) |
| Trial ID | NCT06571149 on ClinicalTrials.gov |
What this trial studies
This international, multicenter trial investigates the safety and efficacy of intravenous thrombolysis (IVT) in adults who have experienced an acute ischemic stroke (AIS) and have taken direct oral anticoagulants (DOAC) within the last 48 hours. Participants will be randomly assigned to receive either IVT combined with standard care or standard care alone. The study aims to determine if IVT leads to better outcomes at 90 days compared to standard treatment in this specific patient population. A total of 906 participants will be enrolled across several high-volume stroke centers.
Who should consider this trial
Good fit: Ideal candidates are adults who have suffered an acute ischemic stroke and have taken DOACs within the last 48 hours.
Not a fit: Patients who are not eligible for IVT due to contraindications or those who have not taken DOACs within the specified timeframe 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: Other studies have explored thrombolysis in anticoagulated patients, but this specific approach is novel and aims to provide definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Informed consent (deferred consent when possible according to national legislation)
* AIS eligible to receive intravenous alteplase/tenecteplase as per standard of care disabling according to the judgement of the treating physician
* DOAC ingestion within 48 hours prior to enrollment, or patient with an ongoing prescription of DOAC but exact time point of last intake is unknown.
* Either
* Can be randomized within 4 hours 15 minutes and treated within 4 hours 30 minutes of last known well time OR
* MRI showing a pattern of "DWI-FLAIR-mismatch", i.e. acute ischemic lesion visibly on DWI ("positive DWI") but no marked parenchymal hyperintensity visible on FLAIR ("negative FLAIR") indicative of an acute ischemic lesion ≤4.5 hours of age AND Treatment can be started within 4.5 hours of symptom recognition (e.g., awakening).
Exclusion Criteria:
* Contra-indications to IVT by the current standard of care of the treating physicians with the exception of recent DOAC intake as specified above.
* Intended reversal by specific or unspecific reversal agents
* Pregnancy or lactating women. To be reasonable sure to exclude women with ongoing pregnancy, women are not considered of childbearing potential if they fulfill the following criteria
* Age \> 55 years OR
* Age \< 55 years and at least 12 months since last menstrual period OR
* Have had a documented surgical sterilization
* Patient \< 18 years of age (since the benefit of IVT is unproven in this population)
Since the benefit of IVT might be smaller in patients in which additional endovascular treatment is planned, the investigators will cap patients with intended mechanical thrombectomy at 20% of the trial population. If this number is reached, the following additional exclusion criterion will be applied:
* Intended treatment with endovascular reperfusion strategies
Where this trial is running
Leuven and 13 other locations
- UZ Leuven — Leuven, Belgium (Not_yet_recruiting)
- Hamilton Health Sciences — Hamilton, Ontario, Canada (Not_yet_recruiting)
- GHU Paris Psychiatrie et Neurosciences, Sainte Anne — Paris, France (Not_yet_recruiting)
- Heidelberg University Hospital — Heidelberg, Germany (Not_yet_recruiting)
- "Attikon" University Hospital — Athens, Greece (Not_yet_recruiting)
- National Cerebral and Cardiovascular Center Osaka — Osaka, Kansai, Japan (Not_yet_recruiting)
- Academic Medical Center Amsterdam, Department of Neurology — Amsterdam, Netherlands (Not_yet_recruiting)
- Canterbury District Health Board — Christchurch, New Zealand (Not_yet_recruiting)
- Akershus Hospital — Oslo, Norway (Not_yet_recruiting)
- Lisbon Central University Hospital Centre — Lisbon, Portugal (Not_yet_recruiting)
- Vall d'Hebron Stroke Center — Barcelona, Spain (Not_yet_recruiting)
- University Hospital Basel — Basel, Switzerland (Not_yet_recruiting)
- Inselspital Bern — Bern, Switzerland (Recruiting)
- Kantonsspital St. Gallen — Sankt Gallen, Switzerland (Recruiting)
Study contacts
- Study coordinator: Thomas Meinel, MD, PhD
- Email: thomas.meinel@insel.ch
- Phone: +41 31 66 4 25 67
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.