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Stroke, Acute IschemicPhase 3CHOICE2NCT05797792

CHemical OptImization of Cerebral Embolectomy 2 (CHOICE 2).

A Phase 3 study testing Intraarterial alteplase in people with Stroke, Acute Ischemic and Stroke, Acute, run by Hospital Clinic of Barcelona at 14 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multi-center, randomized, parallel-group, superiority study to compare the efficacy of adjunct intra-arterial rt-PA versus not adjunct intra-arterial rt-PA in the improvement of the efficacy of mechanical thrombectomy in patients with large vessel occlusion acute ischemic stroke. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Acute Ischemic, Stroke, Acute
What is being tested?
Intraarterial alteplase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
14 sitesSpain
Study dates
18 Nov 2023to 14 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Patients with symptomatic large vessel occlusion (LVO) in the anterior circulation (ICA, ACA or MCA) treated with MT resulting in a mTICI score 2b/3 at end of the procedure. Patients with a mTICI score 2b/3 on the diagnostic cerebral angiography before the onset of MT are also eligible for the study.
  • Estimated delay to onset of rescue intraarterial rt-PA administration <24 hours from symptom onset, defined as the point in time the patient was last seen well.
  • No significant pre-stroke functional disability (modified Rankin scale 0-1), or mRS >1 that according to the investigator is not related to neurological disease (i.e., amputation, blindness)
  • Age ≥18
  • ASPECTS >6 on non-contrast CT (NCCT) scan if symptoms lasting <4.5 hours of last seen well. In patients with >4.5h of last seen well, a CT-perfusion (Flow maps) or MRI-perfusion should be considered instead of NCCT, especially if >9h have elapsed, or in seriously ill patients (i.e., NIHSS>17). Nonetheless, if a perfusion study is not available, NCCT can still be used as long as it is confirmed without a doubt that the ASPECTS is > 6.
  • Informed consent, obtained from patient or acceptable patient surrogate, or Differed Informed Consent (DIC) to avoid any delay in the initiation of the mechanical thrombectomy and the i.a thrombolysis. The DIC will be signed by the patient or acceptable patient surrogate at any time after the tPA treatment is started.

Who cannot join

  • NIHSS score on admission >25
  • Contraindication to IV t-PA as per local national guidelines (except time to therapy)
  • Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy during the first 24h
  • Need of more than 3 passes (per vessel) or more than a total of 5 passes (in more than one vessel) to complete the endovascular procedure
  • Female who is pregnant or lactating or has a positive pregnancy test at time of admission
  • Current participation in another investigation drug or device treatment study
Show all 21Show fewer
  • Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
  • Known coagulopathy, INR > 1.7
  • Platelets < 50,000
  • Renal Failure as defined by a serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate [GFR] < 30
  • Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason
  • Any hemorrhage on CT/MRI
  • Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
  • Suspicion of aortic dissection
  • Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol
  • History of life-threatening allergy (more than rash) to contrast medium
  • SBP >185 mmHg or DBP >110 mmHg refractory to treatment
  • Serious, advanced, terminal illness with anticipated life expectancy < 6 months
  • Pre-existing neurological or psychiatric disease that would confound evaluation
  • Presumed vasculitis or septic embolization
  • Unlikely to be available for 90-day follow-up (i.e., no fixed home address, visitor from overseas)

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Spain14 sites

  • Hospital Universitario de A Coruña

    A Coruña, Spain

  • Hospital Universitario Dr. Balmis

    Alicante, Spain

  • Hospital Germans Trías i Pujol

    Badalona, Spain

  • Hospital Clinic Barcelona

    Barcelona, Spain, 08014

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Hospital Universitario de Cruces

    Bilbao, Spain

  • Hospital Josep Trueta

    Girona, Spain

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, Spain

  • Hospital Universitario Son Espases

    Palma de Mallorca, Spain

  • Hospital Universitario de Navarra

    Pamplona, Spain

  • Hospital Universitario de Donostia

    San Sebastián, Spain

  • Hospital Univesitario y Politénico La Fe

    Valencia, Spain

  • Hospital Universitario de Valladolid

    Valladolid, Spain

Other trials in Spain

About this study

Official title: CHemical OptImization of Cerebral Embolectomy in Patients With Acute Stroke Treated With Mechanical Thrombectomy 2 (CHOICE 2 TRIAL)

Multi-center, randomized, parallel-group, superiority study to compare the efficacy of adjunct intra-arterial rt-PA versus not adjunct intra-arterial rt-PA in the improvement of the efficacy of mechanical thrombectomy in patients with large vessel occlusion acute ischemic stroke.

Being tested
Intraarterial alteplase
Keywords
Mechanical Thrombectomy, Recanalization, Reperfusion, Alteplase
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraarterial alteplaseDrug

    Also called Intraarterial recombinant tissue plasminogen activator (rt-PA)

    See arm/group descriptions.

Study groups in NCT05797792
Study groupRoleWhat they receive
Intraarterial alteplaseExperimentalAll the patients will be given a 15 minutes IA infusion of alteplase (Actylise®) at a drug concentration of 1.0 mg/ml. At 15 minutes of IA treatment onset, the infusion will be stopped and the angiographic score assessed. Study drug will be prepared according to the following steps: 1/ Dilute 2 vials of 10 mgs (rt-PA) in 20 cc of sterile water for injection (SWI), to attain a 20 ml solution at a concentration of 1mg/ml; 2. Calculate the volume of cc of infusion and therefore the total dose as per the formula: (Patient's weight in Kgs multiplied by 0.225). A patient of 89 Kgs or more will receive 20.0 cc of infusion for 15 min, totaling a dose of 20.0 mg of rt-PA.
Receives: Drug: Intraarterial alteplase
No interventionNo interventionPatients allocated to this arm will receive a similar care to patients allocated to IA alteplase except the thrombolytic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Rankin Scale at day 90

    Proportion of patients with Modified Rankin Scale 0 or 1 at day 90 +/- 15d

    Measured: 90 days post treatment

Secondary outcomes (6)

  1. Microvascular hypoperfusion on follow-up brain CTP

    Proportion of patients with abnormal microvascular hypoperfusion on CT Perfusion

    Measured: 36±24hours post treatment

  2. Volume of hypoperfusion on brain CTP

    Volume of hypoperfusion on brain CTP

    Measured: at 36h±24h post treatment

  3. Infarct Expansion Ratio (IER): Final infarct to initial ischemic tissue volumes on brain CTP

    Infarct Expansion Ratio (IER): Final infarct to initial ischemic tissue volumes on brain CTP at 36±24hours post MT.

    Measured: 36±24hours post treatment

  4. Barthel Scale score

    Barthel Scale score of 95 to 100, (min value 0, max value 100, higher score better outcome)

    Measured: day 90 post treatment

  5. EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D-3L)

    Quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D-3L) The score has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.

    Measured: day 90 post treatment

  6. Shift analysis of the modified Rankin Scale (mRS)

    Shift analysis of the modified Rankin Scale (mRS), at day 90 (min value 0, max value 6, higher score worse outcome)

    Measured: day 90 post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start18 Nov 2023
  3. Primary completion26 Aug 2025
  4. Study completion14 Nov 2025

Resources

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
Model description
Multicenter, prospective, randomized, open, blinded end-point assessment phase III trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05797792
Sponsor's protocol ID
CHOICE 2
Other IDs
2023-504262-32, 2023
Acronym
CHOICE2
Status last verified
Sep 2026
First submitted
9 Mar 2023
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data on outcome measures will be published along with the main results of the trial.

Publications

  • Chamorro A, Blasco J, Lopez A, Amaro S, Roman LS, Llull L, Renu A, Rudilosso S, Laredo C, Obach V, Urra X, Planas AM, Leira EC, Macho J. Complete reperfusion is required for maximal benefits of mechanical thrombectomy in stroke patients. Sci Rep. 2017 Sep 14;7(1):11636. doi: 10.1038/s41598-017-11946-y.

    PubMed 28912596

  • Davalos A, Cobo E, Molina CA, Chamorro A, de Miquel MA, Roman LS, Serena J, Lopez-Cancio E, Ribo M, Millan M, Urra X, Cardona P, Tomasello A, Castano C, Blasco J, Aja L, Rubiera M, Gomis M, Renu A, Lara B, Marti-Fabregas J, Jankowitz B, Cerda N, Jovin TG; REVASCAT Trial Investigators. Safety and efficacy of thrombectomy in acute ischaemic stroke (REVASCAT): 1-year follow-up of a randomised open-label trial. Lancet Neurol. 2017 May;16(5):369-376. doi: 10.1016/S1474-4422(17)30047-9. Epub 2017 Mar 16.

    PubMed 28318984

  • Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17.

    PubMed 25882510

  • Renu A, Blasco J, Millan M, Marti-Fabregas J, Cardona P, Oleaga L, Macho J, Molina C, Roquer J, Amaro S, Davalos A, Zarco F, Laredo C, Tomasello A, Guimaraens L, Barranco R, Castano C, Vivas E, Ramos A, Lopez-Rueda A, Urra X, Muchada M, Cuadrado-Godia E, Camps-Renom P, Roman LS, Rios J, Leira EC, Jovin T, Torres F, Chamorro A; CHOICE Investigators. The Chemical Optimization of Cerebral Embolectomy trial: Study protocol. Int J Stroke. 2021 Jan;16(1):110-116. doi: 10.1177/1747493019895656. Epub 2019 Dec 18.

    PubMed 31852410

  • Renu A, Millan M, San Roman L, Blasco J, Marti-Fabregas J, Terceno M, Amaro S, Serena J, Urra X, Laredo C, Barranco R, Camps-Renom P, Zarco F, Oleaga L, Cardona P, Castano C, Macho J, Cuadrado-Godia E, Vivas E, Lopez-Rueda A, Guimaraens L, Ramos-Pachon A, Roquer J, Muchada M, Tomasello A, Davalos A, Torres F, Chamorro A; CHOICE Investigators. Effect of Intra-arterial Alteplase vs Placebo Following Successful Thrombectomy on Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke: The CHOICE Randomized Clinical Trial. JAMA. 2022 Mar 1;327(9):826-835. doi: 10.1001/jama.2022.1645.

    PubMed 35143603

  • Laredo C, Rodriguez A, Oleaga L, Hernandez-Perez M, Renu A, Puig J, Roman LS, Planas AM, Urra X, Chamorro A. Adjunct Thrombolysis Enhances Brain Reperfusion following Successful Thrombectomy. Ann Neurol. 2022 Nov;92(5):860-870. doi: 10.1002/ana.26474. Epub 2022 Aug 23.

    PubMed 36054449

  • Chamorro A, Torres F. Intra-arterial Alteplase vs Placebo After Successful Thrombectomy and Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke-Reply. JAMA. 2022 Jun 28;327(24):2456. doi: 10.1001/jama.2022.7430. No abstract available.

    PubMed 35763000

  • Renu A, Fernandez-Couto MD, de la Riva P, Delgado-Mederos R, Herrera M, Morales A, Terceno M, Lopez-Hernandez N, Martinez-Galdamez M, Dorado L, Vega P, Morales-Caba L, Gonzalez E, Alonso M, Barredo Benitez P, Bermejo R, Cabero-Arnold A, Cabrera-Maqueda JM, Vargas M, Calleja Bonilla A, Calleja S, Diaz-Perez J, Rudilosso S, Doncel-Moriano A, Feal MJ, Gallego JI, Hurtado P, Laredo C, Llull L, Bartolome I, Martinez-Calvo A, Ortega-Sanchez A, Rodriguez-Vazquez A, Rodriguez-Caamano I, Singla A, Silva Y, Tarruella Hernandez D, Oleaga L, San Roman Manzanera L, Serena J, Freijo MM, Perez de la Ossa N, Castellanos M, Arenillas-Lara JF, Torres F, Leira EC, Amaro S, Urra X, Chamorro A; CHOICE-2 Investigators. Adjunctive Intra-Arterial Alteplase After Successful Thrombectomy for Acute Ischemic Stroke: The CHOICE-2 Randomized Clinical Trial. JAMA. 2026 Jun 2;335(21):1859-1869. doi: 10.1001/jama.2026.5164.

    PubMed 42096239

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intraarterial alteplase in people with Stroke, Acute Ischemic and Stroke, Acute, run by Hospital Clinic of Barcelona at 14 sites in Spain.

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 6 inclusion and 21 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: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin Scale at day 90 (time frame: 90 days post treatment). 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 NCT05797792, which also lists 8 linked publications.

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 18 Sep 2026.

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