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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

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

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

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

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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:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days +/- 2 weeks post-randomization

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 3Eligibility criteria met