Intra-arterial alteplase after successful reperfusion for anterior circulation ischemic stroke
Intra-Arterial Thrombolysis After SUCCESSful Angiographic Recanalization in Acute Large Vessel Occlusion Stroke of the Anterior Circulation: the IA-SUCCESS Multicenter, Randomized Clinical Trial
This trial tests whether giving intra-arterial alteplase after successful reperfusion improves 90-day functional outcomes for adults with anterior circulation large vessel occlusion stroke.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 626 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Nancy) |
| Trial ID | NCT06768138 on ClinicalTrials.gov |
What this trial studies
IA-SUCCESS is a prospective phase 3, multicenter, randomized open-label trial with blinded endpoint assessment comparing adjunct intra-arterial alteplase versus no adjunct therapy after angiographic reperfusion (eTICI 2b-2c-3) in anterior circulation large vessel occlusion stroke. Eligible patients are randomized in the angiosuite after initial reperfusion achieved by intravenous thrombolysis, bridging therapy, or mechanical thrombectomy. The experimental arm receives intra-arterial alteplase 0.225 mg/kg (maximum 20 mg) infused through a guiding catheter in the internal carotid artery over 15 minutes, and the primary outcome is a shift toward better 90-day modified Rankin Scale scores; health-economic and budget-impact analyses are included as secondary objectives. Safety monitoring focuses on hemorrhagic complications and other procedure-related adverse events.
Who should consider this trial
Good fit: Adults (≥18) with anterior circulation large vessel occlusion stroke who achieved successful angiographic reperfusion (eTICI 2b-2c-3) after acute reperfusion therapy, with pre-stroke mRS 0–2 and NIHSS ≥5, presenting within guideline time windows are ideal candidates.
Not a fit: Patients with posterior circulation strokes, unsuccessful reperfusion (<eTICI2b), poor pre-stroke function, active contraindications to thrombolysis (e.g., platelets <100,000/mm3, INR >1.7, recent anticoagulant activity), or who cannot speak French are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adjunct intra-arterial alteplase could improve functional recovery by treating distal occlusions and microvascular obstruction that mechanical devices cannot reach.
How similar studies have performed: Smaller observational studies and early-phase trials have suggested possible benefit of intra-arterial thrombolysis for distal or microvascular occlusions, but large randomized phase 3 evidence is limited, making this approach still relatively unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nancy
- CHRU Nancy — Nancy, France (Recruiting)
Study contacts
- Study coordinator: Benjamin GORY, MD, PHD
- Email: b.gory@chru-nancy.fr
- Phone: +33 3 83 85 15 01
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.