Acute Ischemic StrokeROXANENCT05873309
The Role of OXytocin in Acute Ischemic Stroke reconvAlesceNcE: The ROXANE Study
An observational study of Acute Ischemic Stroke, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Evidence suggests that oxytocin has a neuroprotective role on a systemic and cellular level in the context of acute ischemic stroke (AIS). The investigators therefore hypothesize that high levels of circulating oxytocin measured within the first 72 hours after symptom onset are associated with lower mortality and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 386 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Apr 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For the ROXANE cohort the investigators plan to recruit patients with acute ischemic stroke from the University Hospital in Basel.
Who may be able to join
- Rapid onset of a focal neurologic deficit, with signs or symptoms persisting beyond 24 hours and not associated with infection, trauma, or tumor of the brain, severe metabolic disorders, or chronic degenerative neurologic disease; or
- the development of an acute focal neurologic deficit persisting >24 hours in conjunction with brain imaging consistent with acute ischemic stroke. The CT or MRI may either show a new infarct or no change from the study performed at entry, i.e., the diagnosis is clinical and does not require CT/MRI confirmation. Secondary hemorrhagic infarction is permissible.
- First blood sample at the stroke unit is taken within 24 hours from symptom onset.
Who cannot join
- Patients below 18 years
- Hemorrhagic stroke or patients discharged from the hospital with a diagnosis different from ischemic stroke (i.e., stroke mimics)
- Missing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Evidence suggests that oxytocin has a neuroprotective role on a systemic and cellular level in the context of acute ischemic stroke (AIS). The investigators therefore hypothesize that high levels of circulating oxytocin measured within the first 72 hours after symptom onset are associated with lower mortality and favorable outcome in acute ischemic stroke.
Read the detailed description
The preliminary data suggest a possible neuroprotective role of oxytocin via endocrine as well as paracrine effects, underscoring that oxytocin levels in the acute phase of stroke may have a considerable influence on patient outcomes. However, the role of oxytocin in acute ischemic stroke patients has, to our knowledge, never been investigated. If oxytocin really shows a strong associated with functional outcomes after stroke and given the fact that commercially available oxytocin can be safely administered via nasal spray, oxytocin would become an innovative and highly interesting novel therapeutic agent for ischemic stroke patients in the near future. For the ROXANE cohort the investigators plan to recruit patients with acute ischemic stroke from the University Hospital in Basel. The study is designed as an observational cohort study, because an observational study is currently at this stage of knowledge (effect of oxytocin in vitro and in vivo (animal models)), the best study design. It harbors minimal harm, but still allows us to adequately estimate the association of oxytocin levels in humans with stroke outcome. If it is possible to establish this association in humans based on results of the planned observation study, the investigators will be able to plan an interventional trial, which may directly beneficially impact clinical outcome of stroke patient.
- Conditions
- Acute Ischemic Stroke
- Keywords
- oxytocin, blood biomarkers
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day mortality Rate
The 90-day mortality rate will be assessed via a structured telephone interview on day 90 (+/- 10)
Measured: 90 days after stroke
90-day functional outcome
The 90-day functional outcome will be assessed with the modified Ranking Scale (mRS) via a structured telephone interview on day 90 (+/- 10). The modified Ranking Scale is a 6 point disability scale with possible scores ranging from 0 to 5. 0= no symptoms, 5 = severe disability. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials. A favorable outcome is defined as a mRS score of 0 to 2 points.
Measured: 90 days after stroke
Secondary outcomes (1)
Assessment of post-stroke symptoms
Patient Health Questionnaire-9 (PHQ-9) will be assessed via a structured telephone interview. The PHQ-9 is scored 0 to 27, with scores >/= 10 indicating a possible depressive disorder.
Measured: 90 days after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start26 Apr 2023
- Primary completion23 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Academy of Medical Sciences (SAMS)
- Responsible party
- Sponsor
- Investigators
- Johannes Frenger, Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873309
- Sponsor's protocol ID
- 2023-00608; ko23katan
- Other IDs
- 2023
- Acronym
- ROXANE
- Status last verified
- Mar 2025
- First submitted
- 15 May 2023
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of OXytocin in Acute Ischemic Stroke reconvAlesceNcE: The ROXANE Study
- ClinicalTrials.gov ID
- NCT05873309
- Acronym / sponsor ID
- ROXANE / 2023-00608; ko23katan
- Conditions
- Acute Ischemic Stroke
- Keywords
- oxytocin, blood biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss Academy of Medical Sciences (SAMS)
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evidence suggests that oxytocin has a neuroprotective role on a systemic and cellular level in the context of acute ischemic stroke (AIS). The investigators therefore hypothesize that high levels of circulating oxytocin measured within the first 72 hours after symptom onset are associated with lower mortality and favorable outcome in acute ischemic stroke.
Detailed description
The preliminary data suggest a possible neuroprotective role of oxytocin via endocrine as well as paracrine effects, underscoring that oxytocin levels in the acute phase of stroke may have a considerable influence on patient outcomes. However, the role of oxytocin in acute ischemic stroke patients has, to our knowledge, never been investigated. If oxytocin really shows a strong associated with functional outcomes after stroke and given the fact that commercially available oxytocin can be safely administered via nasal spray, oxytocin would become an innovative and highly interesting novel therapeutic agent for ischemic stroke patients in the near future. For the ROXANE cohort the investigators plan to recruit patients with acute ischemic stroke from the University Hospital in Basel. The study is designed as an observational cohort study, because an observational study is currently at this stage of knowledge (effect of oxytocin in vitro and in vivo (animal models)), the best study design. It harbors minimal harm, but still allows us to adequately estimate the association of oxytocin levels in humans with stroke outcome. If it is possible to establish this association in humans based on results of the planned observation study, the investigators will be able to plan an interventional trial, which may directly beneficially impact clinical outcome of stroke patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For the ROXANE cohort the investigators plan to recruit patients with acute ischemic stroke from the University Hospital in Basel.
Key inclusion criteria (3 listed)
- Rapid onset of a focal neurologic deficit, with signs or symptoms persisting beyond 24 hours and not associated with infection, trauma, or tumor of the brain, severe metabolic disorders, or chronic degenerative neurologic disease; or
- the development of an acute focal neurologic deficit persisting >24 hours in conjunction with brain imaging consistent with acute ischemic stroke. The CT or MRI may either show a new infarct or no change from the study performed at entry, i.e., the diagnosis is clinical and does not require CT/MRI confirmation. Secondary hemorrhagic infarction is permissible.
- First blood sample at the stroke unit is taken within 24 hours from symptom onset.
Key exclusion criteria (3 listed)
- Patients below 18 years
- Hemorrhagic stroke or patients discharged from the hospital with a diagnosis different from ischemic stroke (i.e., stroke mimics)
- Missing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
90-day mortality Rate
Time frame: 90 days after stroke
The 90-day mortality rate will be assessed via a structured telephone interview on day 90 (+/- 10)
90-day functional outcome
Time frame: 90 days after stroke
The 90-day functional outcome will be assessed with the modified Ranking Scale (mRS) via a structured telephone interview on day 90 (+/- 10). The modified Ranking Scale is a 6 point disability scale with possible scores ranging from 0 to 5. 0= no symptoms, 5 = severe disability. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials. A favorable outcome is defined as a mRS score of 0 to 2 points.
1 secondary outcome
Assessment of post-stroke symptoms
Time frame: 90 days after stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Frenger, Dr. med. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day mortality Rate (time frame: 90 days after stroke). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.