Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants (DO-IT Cohort)

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Ischemic Stroke

Treatments: Drug: Tenecteplase and Alteplase

Study type: Observational

Funder types: Other

Identifiers

NCT06556446

2023-01175

Details and patient eligibility

About

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.

Enrollment: 2,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of acute ischemic stroke with indication for IVT according to applicable guidelines
2. Time from symptom onset or last known well <12 hours
3. Admission NIHSS of 2 points or more
4. either DOAC ingestion within 48 hours prior to expected timepoint of IVT bolus, or patient with an ongoing prescription of DOAC, but exact timepoint of last intake not verifiable in the emergency setting. (regardless of whether intravenous thrombolysis was given) OR DOAC prescription (any intake within the last 7 days) and receiving intravenous thrombolysis
5. Informed consent (if obtainable and in those international sites where this is legally required) for the prospective part

Exclusion criteria

1. Patient refused the use of biological data for research purposes (Switzerland)
2. Any acute or subacute intracranial hemorrhage (ICH) identified by admission CT or MRI on brain scan
3. Documentation of any other absolute contraindications to IVT in the medical record
4. Significant pre-stroke disability (mRS score of 5), including known advanced dementia
5. Known (serious) sensitivity to Alteplase/Tenecteplase or any of the excipients
6. Pregnancy or lactating women.

Trial design

2,800 participants in 3 patient groups

DOAC+IVT

Description:

Acute ischemic Stroke patients with recent DOACs intake receive IVT.

Treatment:

Drug: Tenecteplase and Alteplase

DOAC

Description:

Acute ischemic Stroke patients with recent DOAC intake do not receive IVT.

IVT Controls

Description:

Acute ischemic Stroke patients without recent DOAC intake receive IVT.