- Treatment of Acute Ischemic Stroke (ReMEDy2 Trial) — Recruiting • Phase II • Cardiology / Cardiovascular • NCT05065216.
- What is being tested: DM199 (rinvecalinase alfa), a novel therapeutic agent designed to improve outcomes in acute ischemic stroke caused by small and medium vessel occlusions, assessed for safety and efficacy in a Phase 2/3 trial.
- Patient eligibility overview: Adults presenting within 24 hours of acute ischemic stroke onset with moderate stroke severity; specifically those with small and medium vessel occlusions (excluding large vessel disease amenable to thrombectomy).
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
This is a Phase 2/3 study evaluating the safety and efficacy of DM199 (rinvecalinase alfa) in treating participants with moderate stroke severity, who present within 24 hours of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions. This study focuses on participants with limited treatment options. Participants who have or will receive mechanical thrombectomy (MT) are not eligible for participation. Additionally, participants who have received fibrinolytics are excluded unless they experience a persistent neurological deficit of moderate severity six or more hours after fibrinolytic treatment. Participants considered…
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- Participant is between 18 and 90 years of age inclusive.
- Participant weight is 40 kg to 166 kg inclusive.
- Participant to be randomized and treatment initiated within 24 hours of last known normal/AIS stroke onset.
- Participant has NIHSS ≥5 and ≤15 at approximately the time of randomization. This criterion also applies to participants who meet the following conditions: * The participant initially presents with an NIHSS score below 5 but clinically worsens, including cases of progressing stroke / stroke-in-evolution, resulting in a subsequent persistent NIHSS score of ≥5 and ≤15; and * Participant meets all other inclusion and
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.