NCT04785066CompletedPhase 2
Evaluation of the efficacy of intra venous dornase alfa (Pulmozyme®) on arterial recanalization in post-thrombectomy angiography in patients managed for ischemic stroke with thrombolysis and eligible for thrombectomy: a single-center phase II trial.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Oct 2024
Brief summary (registry, in English)
To evaluate in patients managed for ischemic stroke by thrombolysis and eligible for thrombectomy, the efficacy of dornase alfa (Pulmozyme®) intravenous administration on arterial recanalization in post-thrombectomy angiography.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 28 Jun 2024
- Start date
- 19 Aug 2022
- Lead sponsor
- Fondation A De Rothschild
- Diseases
- Stroke
- NCT number
- NCT04785066
- EU CT number
- 2024-515831-31-00
- EudraCT number
- 2021-000939-31
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 44
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergy to Dornase alfa (Pulmozyme®) or to one of its excipients.
Age
- Women of childbearing age (15-49)
Other
- Tandem occlusion defined by proximal intracranial occlusion associated with homolateral extracranial stenosis of the internal carotid artery (>90% stenosis or complete occlusion) on initial MRI
- Intracranial occlusion with suspected underlying arterial stenosis on initial MRI
- mRS score > 2
- Patient benefiting from a legal protection measure
- Patients included in this study are not allowed to participate in other interventional clinical research
- Secondary exclusion criteria: Patients who did not receive the experimental treatment. Excluded patients will be replaced
Who the study is looking for
- Patient aged over 18
- Ischaemic stroke due to proximal intracranial occlusion (internal carotid artery or middle cerebral artery in its M1 segment) isolated from the anterior circulation eligible for cerebral thrombectomy.
- Transferred urgently to the NRI unit at the Fondation Adolphe de Rothschild Hospital for cerebral thrombectomy
- Treated with intravenous thrombolysis (Alteplase or Tenecteplase) according to the 2021 recommendations of the European Stroke Organisation (ESO) with a bolus performed less than 90 minutes before inclusion
- With a DWI-ASPECT score ≥ 5 on initial brain MRI
- Having received complete information about the study and having signed a consent to participate in the study (if it is impossible to provide information and to obtain consent to participate from the person undergoing the research, the information and consent must be obtained from the trusted support person or a family member if present; by way of derogation, inclusion may be carried out by the doctor following an emergency inclusion procedure)
- Member or beneficiary of a social security scheme
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondation A. de Rothschild Coordinator of this site? Confirm its status | Paris | France | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.