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Active, Not Recruiting

NCT Number: NCT05797792

CHemical OptImization of Cerebral Embolectomy 2 (CHOICE 2).

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario de A Coruña, A Coruña, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

Intraarterial alteplase

Drug

See arm/group descriptions.

Other names: Intraarterial recombinant tissue plasminogen activator (rt-PA)

Primary outcomes

  1. Modified Rankin Scale at day 90

    Time frame: 90 days post treatment

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

Secondary outcomes

  1. Microvascular hypoperfusion on follow-up brain CTP

    Time frame: 36±24hours post treatment

    Proportion of patients with abnormal microvascular hypoperfusion on CT Perfusion

  2. Volume of hypoperfusion on brain CTP

    Time frame: at 36h±24h post treatment

    Volume of hypoperfusion on brain CTP

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

    Time frame: 36±24hours post treatment

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

  4. Barthel Scale score

    Time frame: day 90 post treatment

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

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

    Time frame: day 90 post treatment

    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.

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

    Time frame: day 90 post treatment

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

Other outcomes

  1. SAFETY OUTCOME: Mortality at 90 days

    Time frame: Day 90

    Mortality at 90 days

  2. SAFETY OUTCOME: symptomatic intracerebral hemorrahge (sICH ) rate at 24 hours.

    Time frame: 24hours post MT

    Symptomatic ICH will be classified as per the European Cooperative Acute Stroke Study (ECASS) 3 criteria

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Acronym: CHOICE2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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