Networked Drug REpurposing for Mechanism-based neuroPrOtection in Acute Ischaemic STROKE (REPO-STROKE II)
Ischemic Stroke, Acute
About this trial
This is an interventional treatment trial for Ischemic Stroke, Acute
Eligibility Criteria
Inclusion criteria: Informed consent has to be obtained from the patient or a legal representative. In case this is not feasible due to the emergency situation, an alternative informed consent procedure is allowed, according to the current legislation in Germany, as described in section 15.4 and 15.5 of this protocol. Male or female adult, ≥18 to ≤80 years of age. Patients older than 80 years of age may be enrolled after review of an initial safety data set obtained from younger patients as described in section 7.2. Disabling acute ischemic stroke with an NIHSS score of ≤12 at time of randomization. Treatment with IMP can be initiated within 24 hours after the onset of stroke or after last known normal. Exclusion criteria: Patients receiving intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA) for the index event (i.e., the current stroke that led to screening the patient for this trial). Prior inability to walk or to lead an independent life, which is defined as daily need for assistance in performing activities of daily living (ADL). Patients who are delirious, comatose or stuporous (a score of ≥ 2 on item 1.a of the NIHSS). Patients undergoing mechanical thrombectomy or intra-arterial thrombolysis. Detection of hemorrhage on baseline CT. Severe dysphagia with inability to swallow and no indication for nasogastric tube as per opinion of the investigator and thus inability to administer IMP. Systolic blood pressure < 110 mmHg at randomization. Pregnant and breastfeeding patients. Females with childbearing potential must comply with using highly effective methods of contraception as defined in section 9.2. Reported severe ongoing hepatic impairment (Child Pugh C). Reported relevant ongoing renal failure with known GFR <30ml/min. Reported ongoing major depression. Reported ongoing tracheal obstruction. Reported ongoing pulmonary hypertension associated with idiopathic interstitial pneumonias (PHIIP) Reported leucopenia or agranulocytosis. Reported agranulocytosis during previous treatment with thiourea derivatives. Reported hypersensitivity to perphenazine or propylthiouracil or riociguat or any of the other excipients. Participation in another clinical trial within the last four weeks. Reported use of phosphodiesterase (PDE) inhibitors (such as sildenafil, tadalafil, vardenafil) within the last 7 days. Reported use of nitrates or nitric oxide donors (such as amyl nitrite) in any form including recreational drugs called 'poppers' within the last 7 days. Reported use of antithyroid drugs within the last 7 days.
Sites / Locations
- University Hospital Essen, Department of NeurologyRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Riociguat +Propylthiouracil +Perphenazine
standard of care
Triple combination therapy group: ○ each patient in this group will receive two doses (8 +/- 2 hours between doses) of orally administered combination therapy of riociguat, propylthiouracil, and perphenazine, in addition to standard of care.
Control group: each patient in this group will receive only standard of care