Intravenous Thrombolysis for Ischemic Stroke
(DO-IT Trial)

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Insel Gruppe AG, University Hospital Bern

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Informed consent (deferred consent when possible according to national legislation)

I am eligible for a clot-dissolving drug as decided by my doctor.

I have taken a blood thinner within the last 48 hours or am prescribed one but unsure when I last took it.

See 1 more

Exclusion Criteria

My doctor advises against IVT for me, except for recent DOAC use.

I am planned to receive a treatment to reverse my condition.

I am 18 years old or older.

See 2 more

Treatment Details

Interventions

Alteplase (Thrombolytic Agent)
Tenecteplase (Thrombolytic Agent)

Trial OverviewThe 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.

Participant Groups

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.

Alteplase is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Activase for: