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RECRUITING
NCT06571149
PHASE4

Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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.

Official title: Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke on Treatment With Direct Oral Anticoagulants: DO-IT - The DOAC Intravenous Thrombolysis Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

906

Start Date

2025-03-14

Completion Date

2029-04-30

Last Updated

2025-03-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tenecteplase or Alteplase

Patients randomized to intravenous thrombolysis (IVT) treatment will receive intravenous Tenecteplase or Alteplase.

Locations (14)

UZ Leuven

Leuven, Belgium

Hamilton Health Sciences

Hamilton, Ontario, Canada

GHU Paris Psychiatrie et Neurosciences, Sainte Anne

Paris, France

Heidelberg University Hospital

Heidelberg, Germany

"Attikon" University Hospital

Athens, Greece

National Cerebral and Cardiovascular Center Osaka

Osaka, Kansai, Japan

Academic Medical Center Amsterdam, Department of Neurology

Amsterdam, Netherlands

Canterbury District Health Board

Christchurch, New Zealand

Akershus Hospital

Oslo, Norway

Lisbon Central University Hospital Centre

Lisbon, Portugal

Vall d'Hebron Stroke Center

Barcelona, Spain

University Hospital Basel

Basel, Switzerland

Inselspital Bern

Bern, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland