NCT06878066: SIFT

Thrombolysis in Factor Xa-inhibitors Trial

Recruiting now Phase 3 Last updated 2 September 2025

What this trial tests

Phase 3 trial testing thrombolysis therapy in Stroke in 300 participants. Currently enrolling.

Timeline

14 March 2025

Primary endpoint
31 December 2028

31 December 2037

Quick facts

Lead sponsor	Guri Hagberg
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	300
Start date	14 March 2025
Primary completion	31 December 2028
Estimated completion	31 December 2037
Sites	13 locations across Norway

Drugs / interventions tested

• thrombolysis therapy — full drug profile →

Conditions studied

• Stroke — all drugs for Stroke →
• Stroke (in Patients With Atrial Fibrillation) — all drugs for Stroke (in Patients With Atrial Fibrillation) →
• Ischemic Stroke — all drugs for Ischemic Stroke →
• Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →

Sponsor

Guri Hagberg

Who can join

18 and older, any sex, with Stroke or Stroke (in Patients With Atrial Fibrillation). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. This is because doctors worry that IVT might cause dangerous bleeding in the brain.

However, new research suggests that IVT might be safe for these patients. Some studies even show that stroke patients on FXa inhibitors who receive IVT do not have a higher risk of brain bleeding than other stroke patients. But because these studies were not designed as full medical trials, doctors still avoid IVT for this group.

The SIFT trial will compare two groups of stroke patients who take FXa inhibitors:

One group will receive IVT to see if it helps them recover better. One group will not receive IVT, which is the current standard. Doctors will check if IVT helps with recovery and if it causes any serious bleeding. If IVT is found to be safe and effective, this study could change stroke treatment guidelines and help more patients get life-saving care.

Right now, some guidelines say that stroke patients on FXa inhibitors should have a blood test before getting IVT, to measure how much of the drug is in their system. But these tests are not available in most hospitals, and waiting for results could delay important treatment. The SIFT trial will not require this test before giving IVT.

More and more people use FXa inhibitors to prevent strokes, but right now, they are being denied IVT based on old rules. If this study proves that IVT is safe for them, it could help doctors give better care to thousands of stroke patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Trick or Treat(ment): Should We Still Fear Reperfusion Therapy in Anticoagulated Stroke Patients?-Comparable 90-Day Outcomes in a Propensity-Score-Matched Registry Study.
   Seetge J, Cséke B, Karádi ZN, Bosnyák E, et al · · 2025 · PMID 41303182 · DOI 10.3390/jcm14228146