Stroke, Acute IschemicPhase 3IA-SUCCESSNCT06768138
Intra-Arterial Thrombolysis After SUCCESSful Reperfusion in Anterior Circulation Ischemic Stroke
A Phase 3 study testing Intra-arterial infusion of Alteplase in people with Stroke, Acute Ischemic, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic
- What is being tested?
- Intra-arterial infusion of Alteplase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 626 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2025to 1 Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Nancy, 54000
Benjamin GORY, MD, PhD
Benjamin GORY, MD, PhD
About this study
Official title: Intra-Arterial Thrombolysis After SUCCESSful Angiographic Recanalization in Acute Large Vessel Occlusion Stroke of the Anterior Circulation: the IA-SUCCESS Multicenter, Randomized Clinical Trial
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.
Read the detailed description
Prospective phase 3 multicenter with open label blinded endpoint (PROBE) superiority randomized controlled trial, with health-economics evaluation.
The study strategy is to demonstrate the superiority of adjunct intra-arterial thrombolysis compared to no adjunct intra-arterial thrombolysis after successful angiographic reperfusion (eTICI 2b-2c-3) after intravenous alone, bridging therapy, or mechanical thrombectomy alone on 90-day functional outcome rate (shift of 90-day modified Rankin Scale toward a better functional outcome).
Patients with anterior circulation large vessel occlusion stroke will be recruited in the angiosuite by neurologists and/or neuroradiologists in participating centres after acute reperfusion therapy (intravenous thrombolysis alone, bridging therapy, or mecanical thrombectomy alone).
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 and the maximal allowed dose is 20mg. Intra-arterial Alteplase will be injected through the guiding catheter placed in the internal carotid artery during 15 minutes.The total intra-arterial dose must be injected in the absence of complications.
Secondary objectives:
- To assess the clinical and safety of adjunct intra-arterial thrombolysis.
- To assess the cost-effectiveness of adjunct intra-arterial thrombolysis.
- To assess the budget impact of new stroke management strategy in case of successful angiographic reperfusion.
- Conditions
- Stroke, Acute Ischemic
- Being tested
- Intra-arterial infusion of Alteplase
- Keywords
- Ischemic stroke, Thrombectomy, Endovascular treatment, Intra-arterial thrombolysis, Randomized controlled trial, Recanalisation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arterial infusion of AlteplaseDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 (±15) days
Secondary outcomes (6)
To assess the efficacy of adjunct intra-arterial thrombolysis
Distribution of the mRS score (0 to 6)
Measured: 90 (±15) days
To assess the efficacy of adjunct intra-arterial thrombolysis
Excellent functional outcome (mRS 0-1)
Measured: 90 (±15) days
To assess the efficacy of adjunct intra-arterial thrombolysis
Early neurological improvement (reduction in National Institutes of Health Stroke Scale (NIHSS) score by at least 8 points, or NIHSS score of 0-1)
Measured: 24 (±6) hours
To assess the safety of adjunct intra-arterial thrombolysis
Symptomatic and asymptomatic intracerebral hemorrhage within 24-hour on imaging follow-up, according to the Heidelberg classification (imaging core laboratory).
Measured: 24 (±6) hours
To assess the cost-effectiveness of adjunct intra-arterial thrombolysis
Incremental cost-effectiveness and cost-utility ratios of a strategy based on adjunct intra-arterial thrombolysis in case of successful angiographic reperfusion.
Measured: 12 months
To assess the budget impact of new stroke management strategy in case of successful angiographic reperfusion
Total cost of each treatment strategy and net impact on the National Health Insurance System (difference in costs).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jun 2025
- Primary completion16 Sep 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, Acute IschemicStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 626 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin GORY, MD, PhD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768138
- Sponsor's protocol ID
- 2020PI054
- Other IDs
- 2023-506935-14-01, 2023
- Acronym
- IA-SUCCESS
- Status last verified
- Jun 2025
- First submitted
- 13 Dec 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gory B, Richard S, Pop R, Wolff V, Cherifi A, Bretzner M, Henon H, Marnat G, Sibon I, Gentric JC, Timsit S, Di Caterino F, Charbonnier G, Caroff J, Denier C, Consoli A, Lapergue B, Allard J, Gerschenfeld G, Dumas V, Lamy M, Richter SJ, Castagnet H, Veunac L, Bourgeois-Beauvais Q, Desilles JP, Seners P, Naggara O, Januel AC, Fontaine L, Boulouis G, Pasi M, Dargazanli C, Arquizan C, Heck O, Garambois K, Comby PO, Bejot Y, Zhu F, Liao L, Loukoul WA, Derelle AL, Anxionnat R, Kamga MM, Hachit H, Guillemin F, Turc G, Hossu G. Intra-Arterial thrombolysis after SUCCESSful angiographic recanalization in acute large-vessel occlusion stroke of the anterior circulation (IA-SUCCESS): a multicentre, randomised, clinical trial protocol. Eur Stroke J. 2026 Jul 6;11(7):aakag080. doi: 10.1093/esj/aakag080.
PubMed 42439416
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Arterial Thrombolysis After SUCCESSful Angiographic Recanalization in Acute Large Vessel Occlusion Stroke of the Anterior Circulation: the IA-SUCCESS Multicenter, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06768138
- Acronym / sponsor ID
- IA-SUCCESS / 2020PI054
- Conditions
- Stroke, Acute Ischemic
- Keywords
- Ischemic stroke, Thrombectomy, Endovascular treatment, Intra-arterial thrombolysis, Randomized controlled trial, Recanalisation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 626 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 16 Sep 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prospective phase 3 multicenter with open label blinded endpoint (PROBE) superiority randomized controlled trial, with health-economics evaluation.
The study strategy is to demonstrate the superiority of adjunct intra-arterial thrombolysis compared to no adjunct intra-arterial thrombolysis after successful angiographic reperfusion (eTICI 2b-2c-3) after intravenous alone, bridging therapy, or mechanical thrombectomy alone on 90-day functional outcome rate (shift of 90-day modified Rankin Scale toward a better functional outcome).
Patients with anterior circulation large vessel occlusion stroke will be recruited in the angiosuite by neurologists and/or neuroradiologists in participating centres after acute reperfusion therapy (intravenous thrombolysis alone, bridging therapy, or mecanical thrombectomy alone).
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 and the maximal allowed dose is 20mg. Intra-arterial Alteplase will be injected through the guiding catheter placed in the internal carotid artery during 15 minutes.The total intra-arterial dose must be injected in the absence of complications.
Secondary objectives:
- To assess the clinical and safety of adjunct intra-arterial thrombolysis.
- To assess the cost-effectiveness of adjunct intra-arterial thrombolysis.
- To assess the budget impact of new stroke management strategy in case of successful angiographic reperfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjunct intra-arterial thrombolysis | Experimental | Drug: Intra-arterial infusion of AlteplaseAdjunct intra-arterial thrombolysis with Alteplase 0.225mg/kg after intravenous thrombolysis intravenous thrombolysis alone, bridging therapy, or mechanical thrombectomy alone. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-arterial infusion of AlteplasePatients 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 | Drug | Adjunct intra-arterial thrombolysis |
Primary outcome
The superiority of adjunct intra-arterial thrombolysis versus no adjunct intra-arterial thrombolysis
Time frame: 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
6 secondary outcomes
To assess the efficacy of adjunct intra-arterial thrombolysis
Time frame: 90 (±15) days
To assess the efficacy of adjunct intra-arterial thrombolysis
Time frame: 90 (±15) days
To assess the efficacy of adjunct intra-arterial thrombolysis
Time frame: 24 (±6) hours
To assess the safety of adjunct intra-arterial thrombolysis
Time frame: 24 (±6) hours
To assess the cost-effectiveness of adjunct intra-arterial thrombolysis
Time frame: 12 months
To assess the budget impact of new stroke management strategy in case of successful angiographic reperfusion
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Derived from this study: PubMed 42439416Gory B, Richard S, Pop R, Wolff V, Cherifi A, Bretzner M, Henon H, Marnat G, Sibon I, Gentric JC, Timsit S, Di Caterino F, Charbonnier G, Caroff J, Denier C, Consoli A, Lapergue B, Allard J, Gerschenfeld G, Dumas V, Lamy M, Richter SJ, Castagnet H, Veunac L, Bourgeois-Beauvais Q, Desilles JP, Seners P, Naggara O, Januel AC, Fontaine L, Boulouis G, Pasi M, Dargazanli C, Arquizan C, Heck O, Garambois K, Comby PO, Bejot Y, Zhu F, Liao L, Loukoul WA, Derelle AL, Anxionnat R, Kamga MM, Hachit H, Guillemin F, Turc G, Hossu G. Intra-Arterial thrombolysis after SUCCESSful angiographic recanalization in acute large-vessel occlusion stroke of the anterior circulation (IA-SUCCESS): a multicentre, randomised, clinical trial protocol. Eur Stroke J. 2026 Jul 6;11(7):aakag080. doi: 10.1093/esj/aakag080.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intra-arterial infusion of Alteplase in people with Stroke, Acute Ischemic, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin GORY, MD, PHD (+33 3 83 85 15 01 ext. +33, b.gory@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The superiority of adjunct intra-arterial thrombolysis versus no adjunct intra-arterial thrombolysis (time frame: 90 (±15) days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06768138, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.