Effect of Pulmozyme® on artery reopening in stroke patients after thrombectomy
Evaluation of the Efficacy of Dornase Alfa (Pulmozyme®) on Arterial Recanalization in Post-thrombectomy Angiography in Patients with Ischemic Stroke by Thrombolysis and Eligible for Thrombectomy (NETs-target)
This study is testing if a drug called Pulmozyme can help stroke patients who are getting a procedure to remove blood clots have better chances of their arteries reopening.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris) |
| Trial ID | NCT04785066 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the efficacy of dornase alfa, administered intravenously, in patients who have suffered an ischemic stroke and are undergoing thrombectomy. The study focuses on improving arterial recanalization rates, which are currently only achieved in 60% of patients post-thrombectomy. By combining drug treatment with mechanical thrombectomy, the trial aims to enhance the chances of complete reperfusion of occluded arteries. The trial is non-randomized and conducted at a single center, specifically targeting patients with proximal intracranial occlusions eligible for thrombectomy.
Who should consider this trial
Good fit: Ideal candidates include patients with ischemic stroke caused by proximal intracranial occlusions who are eligible for thrombectomy and have been treated with intravenous thrombolysis.
Not a fit: Patients who are pregnant, breastfeeding, or have known allergies to dornase alfa will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for ischemic stroke patients by increasing the rate of complete arterial reperfusion.
How similar studies have performed: While the approach of combining drug treatment with thrombectomy is promising, it is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ischemic stroke by proximal intracranial occlusion (internal carotid artery, middle cerebral artery in its M1 or M2 segment) isolated from the anterior circulation eligible for cerebral thrombectomy. * Transferred to the NRI block for a cerebral thrombectomy. * Treated by thrombolysis intravenous (Aleplase or Tenecteplase) as recommanded by European stroke organisation * With DWI-ASPECT score\>5 to MRI Exclusion Criteria: * Pregnant or breastfeeding woman * Known allergy to Dornase alfa or one of its excipients.
Where this trial is running
Paris
- Hôpital Fondation Adolphe de Rothschild — Paris, France (Recruiting)
Study contacts
- Study coordinator: Jean-Philippe DESILLES
- Email: jpdesilles@for.paris
- Phone: 0148036454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.