NCT06768138 Intra-Arterial Thrombolysis After SUCCESSful Reperfusion in Anterior Circulation Ischemic Stroke
| NCT ID | NCT06768138 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Central Hospital, Nancy, France |
| Condition | Stroke, Acute Ischemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 626 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2028-09-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 626 participants in total. It began in 2025-06-01 with a primary completion date of 2028-09-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Stroke is a leading cause of disability and mortality worldwide. Despite the clinical benefit of mechanical thrombectomy, 1 out of 2 patients treated are functionally independent at 90 days. Achieving the best possible angiographic reperfusion is a key determinant of clinical outcome in acute ischemic stroke patients with anterior circulation large vessel occlusion. Mechanical thrombectomy is standard treatment for large vessel occlusion stroke patients within 24. In the setting of successful (eTICI ≥2b), adjunct intra-arterial thrombolysis may be a promising therapeutic option allowing recanalization of distal arterial occlusions (not accessible to mechanical devices) and improvement of upstream brain reperfusion by targeting microvascular obstruction. The IA-SUCCESS randomized trial aims to assess the clinical and safety of adjunct intra-arterial thrombolysis vs. no adjunct intra-arterial thrombolysis after successful angiographic reperfusion in patients with acute anterior circulation large vessel occlusion stroke.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Pre-stroke mRS 0-2 * Acute ischemic stroke with anterior circulation large vessel occlusion defined as intracranial internal carotid artery, M1, or M2 occlusion proven on CT or MRI * NIHSS score ≥ 5 at admission * Acute reperfusion strategy started within 24h after stroke onset according to the international guidelines * DWI-ASPECTS ≥ 2 (MRI) or CT-ASPECTS ≥ 3 * Delay from imaging to puncture within 3 hours for transferred patients * eTICI 2b-2c-3 after intravenous thrombolysis alone, bridging therapy, or mechanical thrombectomy alone and confirmed by catheter angiogram * Person affiliated to or beneficiary of a social security plan Exclusion Criteria: * Person who do not speak French * Contraindications for intra-arterial thrombolysis: Platelet count \<100 000/mm3, INR \>1.7, AOD use \<48h or biological confirmation of activity and effective heparin treatment * Bleeding-risk complications during the mechanical thrombectomy procedure (e.g carotid dissection, complicated femoral approach) * Bleeding-risk complications consecutive to a fall associated with stroke * More than 5 thrombectomy device * Intracerebral hemorrhage * Occlusion or high grade stenosis treated by stenting * Patient expected to be unable to present or be available for 3-month visit follow-up * Participation in another clinical trial within 30 days prior to the inclusion which the experiment may affect the 90-day mRS score * Woman of childbearing age without effective contraception * Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the French Public Health Code
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06768138 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke, Acute Ischemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06768138 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 626 participants.
Is NCT06768138 currently recruiting?
Yes, NCT06768138 is actively recruiting participants. Contact the research team at b.gory@chru-nancy.fr for enrollment information.
Where is the NCT06768138 trial being conducted?
This trial is being conducted at Nancy, France.
Who is sponsoring the NCT06768138 clinical trial?
NCT06768138 is sponsored by Central Hospital, Nancy, France. The trial plans to enroll 626 participants.
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