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A multicentre, parallel group, randomised, double blind, placebo-controlled, phase II study evaluating the efficacy and safety of reperfusion thrombolytic therapy with intravenous recombinant tissue plasminogen activator (rtPA) for ischaemic stroke in patients on the non-vitamin K antagonist oral anticoagulant after reversing anticoagulant activity with the specific antidote

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518509-17-00
Acronym
NBK241/1/2020
Enrollment
300
Registered
2024-12-09
Start date
2022-01-10
Completion date
Unknown
Last updated
2024-12-09

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

PRIMARY ENDPOINTS – INTERVENTIONAL PART OF THE STROACT STUDY: 1. Transition from disabling (at admission) to non- disabling deficit (0- yes, 1-no). 2. Change in NIHSS between admission and 7-day follow-up., PRIMARY ENDPOINTS – OBSERVATIONAL PART OF THE STROACT STUDY: 1. Outcome in mRS at 90 days (the proportion of patients with AIS with excellent or good functional outcome assessed with modified Rankin scale (mRS), mRS 0-1 and 0-2 respectively) at 90 days (+/- 3 days) after the admission.

Interventions

Sponsors

Medical University Of Gdansk
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
PRIMARY ENDPOINTS – INTERVENTIONAL PART OF THE STROACT STUDY: 1. Transition from disabling (at admission) to non- disabling deficit (0- yes, 1-no). 2. Change in NIHSS between admission and 7-day follow-up., PRIMARY ENDPOINTS – OBSERVATIONAL PART OF THE STROACT STUDY: 1. Outcome in mRS at 90 days (the proportion of patients with AIS with excellent or good functional outcome assessed with modified Rankin scale (mRS), mRS 0-1 and 0-2 respectively) at 90 days (+/- 3 days) after the admission.

Countries

Poland

Outcome results

None listed

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