← Back to Search

Thrombolytic Agent

Intravenous Thrombolysis for Ischemic Stroke (DO-IT Trial)

Phase 4
Waitlist Available
Research Sponsored by Insel Gruppe AG, University Hospital Bern
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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)
Must not have
Intended reversal by specific or unspecific reversal agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days +/- 2 weeks post-randomization
Awards & highlights

Summary

"This trial will test if giving intravenous thrombolysis (IVT) is better than standard medical treatment for people who had a recent stroke while taking a specific type of blood thinner. They will enroll

Who is the study for?
This trial is for adults who've had a stroke within the last 48 hours and have taken direct oral anticoagulants (DOACs) recently. It's not suitable for those with certain medical conditions or treatments that could interfere with the study.
What is being tested?
The DO-IT trial is testing whether intravenous thrombolysis (IVT), using drugs Tenecteplase or Alteplase, can improve outcomes in stroke patients on DOACs better than standard care alone. Participants are randomly chosen to receive either IVT plus standard care or just standard care.
What are the potential side effects?
Potential side effects of IVT may include bleeding complications, allergic reactions, and swelling at the injection site. The severity of side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have taken a blood thinner within the last 48 hours or am prescribed one but unsure when I last took it.
Select...
I can start treatment within 4.5 hours of noticing my stroke symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am planned to receive a treatment to reverse my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days +/- 2 weeks post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days +/- 2 weeks post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Modified Rankin Scale (mRS)
Secondary study objectives
Change from baseline in stroke severity (National Institutes of Health Stroke Scale, NIHSS)
Dichotomized modified Rankin Scale (mRS) 0-2 (good functional outcome)
Health-related Quality of Life (EuroQol 5D-3L questionnaire)
Other study objectives
All-cause mortality
Rate of Major extracranial bleeding
Rate of Symptomatic intracranial hemorrhage

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intravenous Thrombolysis + Best medical treatment (standard of care)Experimental Treatment1 Intervention
Patients will receive intravenous administration of Tenecteplase or Alteplase.
Group II: Best Medical Treatment (standard of care)Active Control1 Intervention
Patients will receive Standard of care/Best medical treatment according to local applicable guidelines, including the current American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation/ European Society of Minimally Invasive Neurological Therapy (ESO/ESMINT) guidelines.

Find a Location

Who is running the clinical trial?

Insel Gruppe AG, University Hospital BernLead Sponsor
796 Previous Clinical Trials
1,846,816 Total Patients Enrolled
25 Trials studying Stroke
16,569 Patients Enrolled for Stroke
Thomas Meinel, MD, PhDStudy DirectorInsel Gruppe AG, University Hospital Bern
1 Previous Clinical Trials
2,800 Total Patients Enrolled
1 Trials studying Stroke
2,800 Patients Enrolled for Stroke
~604 spots leftby Jan 2029
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top