RecruitingPhase 3interventionalRules rewrite

Phase 3: testing thrombolysis therapy for Stroke

Q: Is NCT06878066 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT06878066?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT06878066?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This study looks at whether stroke patients who take FXa inhibitors (a type of blood thinner) can safely receive clot-busting treatment (IVT). IVT is a common emergency treatment for stroke, but current guidelines say it should not be given to people who have taken FXa inhibitors in the last 48 hours.

Official registry: https://clinicaltrials.gov/study/NCT06878066 · Guri Hagberg · enrollment listed as 300

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are thrombolysis therapy. The registry lists allocation as randomized. This study looks at whether stroke patients who take FXa inhibitors (a type of blood thinner) can safely receive clot-busting treatment (IVT).

They plan to enroll about 300 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

The Efficacy and Safety of Intravenous Thrombolysis in Acute Ischemic Stroke Patients With Recent Ingestion of Factor Xa-inhibitors Trial (SIFT)

Interventions: thrombolysis therapy

Primary outcome (registry wording): Early neurological improvement (ENI)

Who it is for (from inclusion criteria)

Ages 18 Years to any
Participant must be 18 years of age or older
Ingestion of FXa inhibitors within the last 48 hours of symptom onset (or ongoing prescription of FXa inhibitor if unknown)
Clinical diagnosis of AIS with disabling neurological deficit
Presenting within 4.5 h of symptom onset or after awakening with symptoms of AIS with FLAIR-DWI mismatch on MRI as judged by the (neuro-) radiologist

Who the registry excludes

Systolic BP \>185 mmHg or diastolic BP \>110 mmHg despite antihypertensive treatment
Known bleeding diathesis; manifest or recent severe bleeding; significant bleeding disorder last 6 months
Prior/Concomitant Therapy
Use of a) direct thrombin (II) inhibitor (Dabigatran) or b) warfarin with an INR ≥1.8; c) heparin \<48 h; d) treatment dose of LMWH \<24 h
Prior/Concurrent Clinical Study Experience
Hypersensitivity to Alteplase or Tenecteplase

Public study contact (from the registry)

Guri Hagberg, MD, PhD

+47 92821843

guhagb@ous-hf.no

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

21 listed

Dept. of Neurology, Aalborg Universitetshospital — Aalborg, Aalborg, Denmark (recruiting)
Dept of Neurology Aarhus University Hospital — Aarhus, Aarhus N, Denmark (recruiting)
Dept. of Medicine, Baerum Hospital — Baerum, Gjettum, Norway (recruiting)
Dept of Medicine, Helse More and Romsdal Health Trust, Aalesund Hospital — Ålesund, Norway (recruiting)
Dept of Medicine, Haraldsplass deaconal Hospital — Bergen, Norway (recruiting)
Dept. Of Neurology, Haukeland University Hopsital — Bergen, Norway (recruiting)
Dept of Neurology, Drammen Hospital Trust — Drammen, Norway (recruiting)
Dept of Neurology, Ostfold Hospital Trust, Kalnes — Grålum, Norway (recruiting)
Dept of Neurology, Hospital of Southern Norway, SSHF — Kristiansand, Norway (recruiting)
Dept of Neurology, Innlandet Hospital Trust, Lillehammer — Lillehammer, Norway (recruiting)
Dept. of Neurology, Oslo University Hospital — Oslo, Norway (recruiting)
Dept of Neurology, Stavanger University Hospital — Stavanger, Norway (recruiting)

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FAQ about this NCT record

Is NCT06878066 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06878066?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06878066?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary