Improving mechanical thrombectomy for acute ischemic stroke
CHemical OptImization of Cerebral Embolectomy in Patients with Acute Stroke Treated with Mechanical Thrombectomy 2 (CHOICE 2 TRIAL)
This study is testing whether adding a medication called alteplase to a procedure for removing blood clots can help people with severe strokes recover better than just using the procedure alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 14 sites (Alicante and 13 other locations) |
| Trial ID | NCT05797792 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of adding intra-arterial alteplase to mechanical thrombectomy in patients suffering from large vessel occlusion acute ischemic stroke. It is a multi-center, randomized, parallel-group study designed to determine if this adjunct treatment improves patient outcomes compared to mechanical thrombectomy alone. Participants will be assessed based on their recanalization success and overall recovery following the procedure. The study aims to provide insights into optimizing treatment protocols for acute ischemic stroke.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with symptomatic large vessel occlusion in the anterior circulation who have undergone mechanical thrombectomy.
Not a fit: Patients with significant pre-stroke functional disabilities or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery rates and outcomes for patients experiencing acute ischemic strokes.
How similar studies have performed: Previous studies have shown promising results with similar adjunct treatments in improving outcomes for acute ischemic stroke patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Alicante and 13 other locations
- Hospital Universitario Dr. Balmis — Alicante, Spain (Recruiting)
- Hospital Germans Trías i Pujol — Badalona, Spain (Not_yet_recruiting)
- Hospital Clinic Barcelona — Barcelona, Spain (Recruiting)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
- Hospital Universitario de Cruces — Bilbao, Spain (Recruiting)
- Hospital Universitario de A Coruña — Coruña, Spain (Recruiting)
- Hospital Josep Trueta — Girona, Spain (Not_yet_recruiting)
- Hospital Universitario Son Espases — Mallorca, Spain (Recruiting)
- Hospital Universitario Virgen de la Arrixaca — Murcia, Spain (Recruiting)
- Hospital Universitario Central de Asturias — Oviedo, Spain (Recruiting)
- Hospital Universitario de Navarra — Pamplona, Spain (Recruiting)
- Hospital Universitario de Donostia — San Sebastián, Spain (Recruiting)
- Hospital Univesitario y Politénico La Fe — Valencia, Spain (Recruiting)
- Hospital Universitario de Valladolid — Valladolid, Spain (Recruiting)
Study contacts
- Principal investigator: Arturo Renú, MD, PhD — Comprehensive Stroke Center, Hospital Clinic Barcelona
- Study coordinator: Martha Vargas, PhD
- Email: mvargas@clinic.cat
- Phone: 0034-93 227 54 00
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.