Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants – a multicentre randomised placebo-controlled clinical trial

Conditions

acute ischemic stroke

Brief summary

Functional outcome (modified Rankin Scale, mRS) 90 days after randomisation

Detailed description

Efficacy Endpoint: Nondisabled (mRS score ≤ 1) functional outcome after 90 days, Efficacy Endpoint: Independent (mRS score ≤ 2) functional outcome after 90 days, Efficacy Endpoint: Early neurological deficit (National Institutes of Health stroke scale) after 24 hours, Efficacy Endpoint: Health-related quality of life (PROMIS®-10) after 90 days, Efficacy Endpoint: Cognitive impairment (Montreal Cognitive Assessment) after 90 days, Safety Endpoint: Any intracranial haemorrhage within 36 hours, Safety Endpoint: Symptomatic intracranial haemorrhage within 36 hours (mSITS-MOST), Safety Endpoint: Fatal intracranial haemorrhage within 30 days, Safety Endpoint: Major haemorrhage (ISTH) within 72 hours, Safety Endpoint: Orolingual angioedema within 4 hours, Safety Endpoint: Death or dependency (mRS score 4–6) after 90 days, Safety Endpoint: All-cause mortality after 90 days, Safety Endpoint: Time to death right-censored at 90 days

Related papers

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Interventions

DRUGPlacebo to Metalyse®

DRUGMetalyse 5 000 units (25 mg) powder for solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Functional outcome (modified Rankin Scale, mRS) 90 days after randomisation	—

Secondary

Measure	Time frame
Efficacy Endpoint: Nondisabled (mRS score ≤ 1) functional outcome after 90 days, Efficacy Endpoint: Independent (mRS score ≤ 2) functional outcome after 90 days, Efficacy Endpoint: Early neurological deficit (National Institutes of Health stroke scale) after 24 hours, Efficacy Endpoint: Health-related quality of life (PROMIS®-10) after 90 days, Efficacy Endpoint: Cognitive impairment (Montreal Cognitive Assessment) after 90 days, Safety Endpoint: Any intracranial haemorrhage within 36 hours, Safety Endpoint: Symptomatic intracranial haemorrhage within 36 hours (mSITS-MOST), Safety Endpoint: Fatal intracranial haemorrhage within 30 days, Safety Endpoint: Major haemorrhage (ISTH) within 72 hours, Safety Endpoint: Orolingual angioedema within 4 hours, Safety Endpoint: Death or dependency (mRS score 4–6) after 90 days, Safety Endpoint: All-cause mortality after 90 days, Safety Endpoint: Time to death right-censored at 90 days	—

Measure

Time frame

Efficacy Endpoint: Nondisabled (mRS score ≤ 1) functional outcome after 90 days, Efficacy Endpoint: Independent (mRS score ≤ 2) functional outcome after 90 days, Efficacy Endpoint: Early neurological deficit (National Institutes of Health stroke scale) after 24 hours, Efficacy Endpoint: Health-related quality of life (PROMIS®-10) after 90 days, Efficacy Endpoint: Cognitive impairment (Montreal Cognitive Assessment) after 90 days, Safety Endpoint: Any intracranial haemorrhage within 36 hours, Safety Endpoint: Symptomatic intracranial haemorrhage within 36 hours (mSITS-MOST), Safety Endpoint: Fatal intracranial haemorrhage within 30 days, Safety Endpoint: Major haemorrhage (ISTH) within 72 hours, Safety Endpoint: Orolingual angioedema within 4 hours, Safety Endpoint: Death or dependency (mRS score 4–6) after 90 days, Safety Endpoint: All-cause mortality after 90 days, Safety Endpoint: Time to death right-censored at 90 days

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Countries

Germany

Outcome results

None listed