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Recruiting Phase 3

Intra-Arterial Thrombolysis After SUCCESSful Reperfusion in Anterior Circulation Ischemic Stroke

NCT06768138 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2025-06-01
Last updated
2025-06-05

Condition(s) studied

Stroke, Acute Ischemic

Investigational drug(s) / intervention(s)

Intra-arterial infusion of Alteplase

Intra-arterial infusion of Alteplase: Patients enrolled in the experimental arm will receive intra-arterial thrombolysis with Alteplase. The dose of Intra-arterial Alteplase is 0.225 mg/kg body weight with a maximal dose of 20 mg

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • The superiority of adjunct intra-arterial thrombolysis versus no adjunct intra-arterial thrombolysis — 90 (±15) days
    The primary endpoint is the severity of disability according to the distribution of scores on the modified Rankin Scale (mRS): mRS 0 to 6

Trial sites (1)

FacilityCityRegionStatus
CHRU Nancy Nancy France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06768138 on ClinicalTrials.gov ↗ ← All trials in France