Dornase alfa for Ischaemic stroke|Acute ischaemic stroke

Inclusion criteria

• {"criterion_text":"- Patients with urgent suspected acute ischemic stroke with symptom onset (last-seen-well) to investigational drug application of less than 12 hours\n- Consent to participate in the study\n- Age ≥ 18 years\n- NIHSS ≥10 at admission"}

Exclusion criteria

• {"criterion_text":"- Presence of any of the following: Sinus or cerebral venous thrombosis, intracerebral hemorrhage, subarachnoid hemorrhage on qualifying imaging (cCT with CT-A or MRI with MR-A). However, petechial hemorrhagic transformation of index infarct and cerebral microhemorrhage may be included.\n- Active malignant tumor disease in the past 6 months.\n- Current known immunosuppression due to immunomodulatory medication with immunosuppressive dose or underlying immunosuppressive disease (e.g., HIV)\n- Acute fulminant infectious disease in the last 7 days (fever > 38.5°C or suspected by investigator)\n- Breastfeeding or pregnant woman, women of childbearing age (under 55 years) without known contraceptive use with positive urine or serum beta-human choriogonadotropin tests\n- Ischemic stroke or myocardial infarction in the previous 30 days\n- Surgery in the previous 30 days, except minor dermatologic, urologic, oral surgery, or gynecologic surgery without anesthesia and wound healing problems, and patients with thrombectomy\n- Estimated or known weight > 100 kg\n- Known allergies or intolerance to dornase alfa (Pulmozyme) or recombinant protein products derived from Chinese hamster ovary cells\n- Thrombocytopenia, leukocyte count <1500/μl\n- Known participation in another clinical trial investigating a drug and/ or medical device in the 7 days prior to study enrollment\n- Severe renal insufficiency with GFR≤29 ml/min/ 1.73m3 and/or renal insufficiency requiring dialysis"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint, IL-1 β concentration in the blood within 24±6 hrs after symptom onset, will be analyzed in the full analysis set, which comes as close as possible to the IIT principle. A mixed linear regression model is calculated with the IL-1 β value (at 24±6hrs & 3 d) as the dependent variable, the randomized group, the IL-1 β value at baseline & the time point, the interaction of time + group, as independent variables and the patient as a random effect.","definition_or_measurement_approach":"IL-1β concentration in blood measured within 24±6 hours after symptom onset; analysis in the full analysis set using a mixed linear regression model with IL-1β (at 24±6 hrs & 3 days) as the dependent variable, randomized group, baseline IL-1β and time point as independent variables, interaction of time and group, and patient as a random effect."}

Secondary endpoints

• {"endpoint_text":"- All secondary endpoints are analyzed descriptively, and differences between the two study arms are explored according to their level of measurement.","definition_or_measurement_approach":"Secondary endpoints will be analyzed descriptively; differences between study arms explored according to measurement level (no further per-endpoint definitions provided in the available JSON)."}

Germany

Earliest CTIS Part Ii Submission Date

29-10-2024

Latest Decision Or Authorization Date

23-04-2026

Processing Time Days

541

Number Of Sites

5

Number Of Participants

36

Primary sponsor

Full Name

Klinikum der Universitaet Muenchen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Charite Universitaetsmedizin Berlin KöR","duties_or_roles":"[{\"id\":1006033,\"code\":\"1\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"University Medical Center Hamburg-Eppendorf","duties_or_roles":"[{\"id\":1006031,\"code\":\"12\"},{\"id\":1006032,\"code\":\"6\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}