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Thrombolytic Agent

Intravenous Thrombolysis + Best medical treatment (standard of care) 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
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days +/- 2 weeks post-randomization
Awards & highlights

Summary

DO-IT is an international, multicenter, prospective, two-arm, randomized, open label, blinded endpoint superiority trial determining the safety and efficacy of intravenous thrombolysis (IVT) in participants experiencing an acute ischemic stroke (AIS) with recent (within the last 48 hours) intake of direct oral anticoagulant (DOAC). For this purpose, 906 adult participants experiencing an AIS with recent DOAC intake will be enrolled at several high-volume international stroke centers and randomly assigned in a ratio of 1:1 to one of two treatment arms: (1) IVT and standard of care/best medical treatment or (2) standard of care/best medical treatment. The DO-IT trial is a definitive test of the hypothesis that IVT is superior to standard of care for achieving better outcome at 90 days in AIS participants with recent DOAC intake.

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

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.

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Who is running the clinical trial?

Insel Gruppe AG, University Hospital BernLead Sponsor
781 Previous Clinical Trials
1,811,792 Total Patients Enrolled
13 Trials studying Ischemic Stroke
8,718 Patients Enrolled for Ischemic Stroke
Thomas Meinel, MD, PhDStudy DirectorInsel Gruppe AG, University Hospital Bern
~604 spots leftby Jan 2029
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