RECRUITING Phase 2 ClinicalTrials.gov

Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD)

Sponsor: Ludwig-Maximilians - University of Munich • ClinicalTrials.gov ID: NCT05880524

Registry updated: 2026-09-11

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Description

The goal of this (multicentric, randomised, placebo-controlled single-blinded; phase 2) clinical trial is to test the hypothesis that DNase 1 administration leads to a reduction in systemic immune response measured in patients after acute ischaemic stroke compared to control treatment. Participants will receive intravenous DNase 1 (500 µg/kg) or placebo (NaCl 0.9%) twice within 24±6 hours after symptom onset (last seen well). Blood samples will be taken at baseline, day 1 and 3. Personal visits will occur on baseline, day 1, 3 and discharge date. A telephone interview will be conducted on day 30±3.

Interventions

Dornase Alfa (Drug)
Patients will receive an intravenous dose of Dornase alfa twice within within 24±6 hours after symptom onset, administered as a bolus.
Isotonic Saline Solution (Drug)
Patients will receive an intravenous dose of Isotonic saline solution twice within within 24±6 hours after symptom onset, administered as a bolus.

Eligibility criteria

Inclusion Criteria: * Patients with suspected acute ischemic stroke with symptom onset (last-seen-well) until Investigational drug application of less than 12 hours. * Consent to participate in the study. * Age ≥ 18 years. * NIHSS ≥10 at admission. Exclusion Criteria: * Presence of any of the following conditions: Sinus or cerebral venous thrombosis, intracerebral haemorrhage, subarachnoid haemorrhage on qualified imaging (cCT with CT-A or MRI with MR-A). However, petechial haemorrhagic transformations of the index infarct and cerebral microhaemorrhages may be included. * Active malignant tumour disease in the last 6 months. * Current known immunosuppression due to immunomodulatory medication with immunosuppressive dose or underlying immunosuppressive disease (e.g. HIV). * Acute fulminant infectious disease in the last 7 days (fever \> 38.5°C or suspected by the Investigator). * Breastfeeding or pregnant woman, women of childbearing age without known use of contraceptives with positive urine or serum beta-human choriogonadotropin test. * Ischemic stroke or myocardial infarction in the previous 30 days. * Surgery in the previous 30 days, except minor dermatological or gynaecological surgery without anaesthesia and wound healing disorders and patients with thrombectomy. * Estimated or known weight \> 100 kg. * Known allergies or intolerance to dornase alfa (Pulmozyme) or recombinant protein products derived from Chinese hamster ovary cells. * Thrombocytopenia, leukocyte count \<1500/μl. * Known participation in another clinical trial investigating a drug and/or medical product in the last 7 days before study inclusion. * Severe renal insufficiency with GFR≤29 ml/min/ 1.73m³ and/or renal insufficiency requiring dialysis.

Conditions

Ischemic Stroke Inflammatory Response

Locations

Institute for Stroke and Dementia Research, Ludwig Maximilian University Munich, University Hospital — Munich, Bavaria, Germany
Charité Universitätsmedizin — Berlin, Germany
University Medical Center Hamburg-Eppendorf — Hamburg, Germany
MHH Hannover — Hanover, Germany
TUM Klinikum München — Munich, Germany

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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