THrombolysis for Acute Wake-up and unclear-onset Strokes with alteplase at 0.6 mg/kg (THAWS) Trial

THrombolysis for Acute Wake-up and unclear-onset Strokes with alteplase at 0.6 mg/kg (THAWS) Trial - THAWS Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011630

Enrollment

300

Registered

2013-09-09

Start date

2014-05-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

acute ischemic stroke

Interventions

Intervention: intravenous rt-PA Control: standard medical therapy including antithrombotics

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Clinical diagnosis of acute ischemic stroke with unknown time of symptom onset Last known well without neurological symptoms >4.5 h of treatment initiation Treatment can be initiated <4.5 h of symptom recognition ASPECTS on DWI >5 No marked parenchymal hyperintensity on FLAIR Baseline NIHSS >=2

Exclusion criteria

Exclusion criteria: Prestroke mRS >1 Ineligible for IV rt-PA according to the Japanese guideline (J Stroke Cerebrovasc Dis. 2013 Jul;22:571-600) Contraindication to MRI, etc

Design outcomes

Primary

Measure	Time frame
modified Rankin Scale 0-1 at 90 days	—

Secondary

Measure	Time frame
A prespecified ordinal analysis of the modified Rankin score at 90 days, symptomatic intracranial hemorrhage within 24 h, Infarct volume at 7 days, Infarct volume growth at 7 days, etc	—

Countries

Japan

Contacts

Public ContactMasatoshi Koga

National Cerebral and Cardiovascular Center Department of Cerebrovascular Medicine

koga@ncvc.go.jp06-6833-5012

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026