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

NCT06768138 | Recruiting Phase 3 DMC

• 2 other identifiers: 2020PI0542023-506935-14-01
• Study Type: interventional
• Target: 626
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute Ischemic

Keywords

Ischemic stroke; Thrombectomy; Endovascular treatment; Intra-arterial thrombolysis; Randomized controlled trial; Recanalisation

Outcome Measures

Primary Outcomes (1)

• The superiority of adjunct intra-arterial thrombolysis versus no adjunct intra-arterial thrombolysis

  The primary endpoint is the severity of disability according to the distribution of scores on the modified Rankin Scale (mRS): mRS 0 to 6

  90 (±15) days

Secondary Outcomes (6)

• To assess the efficacy of adjunct intra-arterial thrombolysis

  90 (±15) days

• To assess the efficacy of adjunct intra-arterial thrombolysis

  90 (±15) days

• To assess the efficacy of adjunct intra-arterial thrombolysis

  24 (±6) hours

• To assess the safety of adjunct intra-arterial thrombolysis

  24 (±6) hours

• To assess the cost-effectiveness of adjunct intra-arterial thrombolysis

  12 months

Study Arms (2)

Adjunct intra-arterial thrombolysis

EXPERIMENTAL

Adjunct intra-arterial thrombolysis with Alteplase 0.225mg/kg after intravenous thrombolysis intravenous thrombolysis alone, bridging therapy, or mechanical thrombectomy alone.

Drug: Intra-arterial infusion of Alteplase

No intra-arterial thrombolysis

NO INTERVENTION

Control group: no intra-arterial thrombolysis after intravenous thrombolysis alone, bridging therapy, or mechanical thrombectomy alone (according to standard of care).

Interventions

Intra-arterial infusion of Alteplase DRUG

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

Adjunct intra-arterial thrombolysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Benjamin GORY, MD, PHD

CONTACT

+33 3 83 85 15 01; b.gory@chru-nancy.fr

Guillaume TURC, MD, PhD

CONTACT

+33 1 45 65 86 65; G.TURC@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary endpoint will be assessed by central, independent blinded and qualified nurse certified in the assessment of the modified Rankin Scale (mRS) following a structured questionnaire of the mRS.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: January 10, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 16, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

FR (1)