Thrombolysis in Factor Xa-inhibitors Trial (SIFT)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oslo University Hospital HF

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

10 Mar 2025 → ongoing

Decision date (initial)

2026-03-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To compare early neurological improvement (ENI) between patients treated with IVT within 4.5 hours after stroke onset and patients treated with the current standard of care, in AIS patients on FXa ihibitors.

Secondary objectives 6

1. To compare clinical neurological improvement using NIHSS (defined as percentage change in NIHSS) at 24 h ± 12 hours between patients treated with IVT and patients treated with the current standard of care.
2. To compare infarct volume at CT/MRI at 24h ±12 hours between patients treated with IVT and patients treated with the current standard of care.
3. To compare functional outcome using modified Rankin Scale at day 90 (+/- 2weeks) between patients treated with IVT and patients treated with the current standard of care.
4. To compare the rate of sICH in AIS patient with ingestion of FXa inhibitors within the last 48 hours and treated with IVT within 4.5 hours after stroke onset versus the expected sICH rate seen in Norway in patients not taking FXa inhibitors prior to IVT.
5. The rate of any ICH after IVT in the treatment arm.
6. To compare the number of deaths of participants in the treatment arms.

Conditions and MedDRA coding

acute ischemic stroke

Regulatory references

Plan to share IPD

Yes

IPD plan description

We plan to share collected information to contribute to a meta-analysis with a similar planned study outgoing from Bern, Switzerland. This includes the results of blood tests, brain imaging and functional tests. Oslo University Hospital is responsible for the transfer of information taking place in accordance with Norwegian law and the EU's personal data protection legislation (GDPR). The code that links patients to personally identifiable information will not be disclosed.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participant must be 18 years of age or older.
2. Ingestion of FXa inhibitors within the last 48 hours of symptom onset (or ongoing prescription of FXa inhibitor if unknown)
3. Clinical diagnosis of AIS with disabling neurological deficit
4. 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.
5. Informed consent.

Exclusion criteria 5

1. Endovascular treatment eligible patients with isolated large vessel occlusion of the intracranial internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or both confirmed by CT or MR angiography and expected time from randomization to groin puncture of <30 minutes.
2. Systolic BP >185 mmHg or diastolic BP >110 mmHg despite antihypertensive treatment
3. Known bleeding diathesis; manifest or recent severe bleeding; significant bleeding disorder last 6 months.
4. Arterial puncture at a noncompressible site; biopsy or lumbar puncture <7 days; major surgery, traumatic external heart massage, obstetrical delivery or serious trauma <14 days; history of intracranial haemorrhage; stroke <2 months, CNS neurosurgery <2 months; serious head trauma <2 months; pericarditis; sepsis; bacterial endocarditis; pericarditis; acute pancreatitis; neoplasm with increased bleeding risk; any serious medical illness likely to interact with treatment (i.e. aortic dissection); confounding pre-existent neurological or psychiatric disease.
5. Any condition that, in the opinion of the treating physician, puts a patient at risk if treated with thrombolysis (i.e. signs of cerebral hemorrhage, known cerebral amyloid angiopathy, CT with signs of early ischemia greater than one-third of the middle cerebral artery territory).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Early neurological improvement, defined as a reduction of ≥8 points on the National Institutes of Health Stroke Scale (NIHSS), or NIHSS of 0-1 at 24 hours ± 12.

Secondary endpoints 6

1. Percentage change in NIHSS from baseline to 24 h ± 12 h.
2. Percent change in infarct volume at 24 h ± 12 hours.
3. Proportion of patients: - obtaining a good functional outcome (mRS 0-2) at day 90 (+/- 2weeks); obtaining an excellent functional outcome (mRS 0-1) at day 90 (+/- 2 weeks); mRS category at day 90 (+/- 2 weeks).
4. Occurrence of sICH on CT/MRI within 36 hours post IVT causally related to an increase of 4 points or more on the NIHSS.
5. Any ICH on CT/MR within 36 hours post IVT.
6. Occurrence of death within 90 days.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

Sponsor organisation

Oslo University Hospital HF

Address

Taarnbygget, Kirkeveien 166 Kirkeveien 166

City

Oslo

Postcode

0450

Country

Norway

Scientific contact point

Organisation

Oslo University Hospital HF

Contact name

Guri Hagberg

Public contact point

Organisation

Oslo University Hospital HF

Contact name

Guri Hagberg

Locations

3 EU/EEA countries · 28 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications