NCT06556446

Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants

Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants: the DOAC - International Thrombolysis (DO-IT) Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,800 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

DO-IT is an international, prospective observational registry evaluating whether the administration of intravenous thrombolysis (IVT) is safe and improves functional outcome in ischemic stroke patients with recent direct oral anticoagulant (DOAC) intake. For this purpose, information on 2800 adult participants experiencing an acute ischemic stroke will be obtained at several high-volume international stroke centers and divided into three groups: IVT with recent DOACs intake (DOAC+IVT), and recent DOAC intake not receiving IVT (DOAC) as well as anonymized patients without DOAC receiving IVT. The patients are followed up for 90 days after the index event. treatment recommendations from the described observations. The investigators hypothesize that also more liberal decisions for IVT in patients with recent DOAC intake are not associated with an increased risk for symptomatic intracerebral hemorrhage (sICH) and result in better functional outcome at 3 month.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Tenecteplase and Alteplase	The timepoints, dose, and type of IVT will be collected as well as any complications occuring.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-03-31
• Completion: 2026-12-31
• First posted: 2024-08-16
• Last updated: 2024-08-16

Locations

33 sites across 15 countries: Austria, Belgium, Canada, France, Germany, Greece, Italy, Norway, Portugal, Serbia, Singapore, Slovenia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study