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The efficacy and Safety of Intravenous thrombolysis in acute ischemic stroke patients with recent ingestion of Factor Xa-inhibitors Trial (SIFT)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509907-34-01
Acronym
SIFT
Enrollment
300
Registered
2025-01-23
Start date
2025-03-10
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute ischemic stroke

Brief summary

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.

Detailed description

Percentage change in NIHSS from baseline to 24 h ± 12 h., Percent change in infarct volume at 24 h ± 12 hours., 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)., Occurrence of sICH on CT/MRI within 36 hours post IVT causally related to an increase of 4 points or more on the NIHSS., Any ICH on CT/MR within 36 hours post IVT., Occurrence of death within 90 days.

Interventions

DRUGRIVAROXABAN
DRUGAPIXABAN
DRUGTENECTEPLASE
DRUGALTEPLASE
DRUGEDOXABAN

Sponsors

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Percentage change in NIHSS from baseline to 24 h ± 12 h., Percent change in infarct volume at 24 h ± 12 hours., 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)., Occurrence of sICH on CT/MRI within 36 hours post IVT causally related to an increase of 4 points or more on the NIHSS., Any ICH on CT/MR within 36 hours post IVT., Occurrence of death within 90 days.

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026