CHemical OptImization of Cerebral Embolectomy in patients with acute stroke treated with mechanical thrombectomy 2 (CHOICE2TRIAL)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Foundation Clinic For Biomedical Research

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

16 Nov 2023 → 13 Nov 2025

Decision date (initial)

2023-10-19

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Instituto de Salud Carlos III

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The study objective is to evaluate whether rt-PA is efficient as an add-on to mechanical thrombectomy in patients with acute ischemic stroke and recanalization with complete or near-complete reperfusion of a proximal vessel occlusion on cerebral angiogram (corresponding to mTICI score 2b/3).

Conditions and MedDRA coding

Cerebral Embolectomy in patients with acute stroke

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients with symptomatic large vessel occlusion (LVO) in the anterior circulation (TICA, ACA or MCA) treated with MT resulting in a mTICI angiographic score 2b/3 at end of the procedure.
2. Estimated delay to onset of rescue IA rt-PA administration <24 hours from symptom onset, defined as the point in time the patient was last seen well.
3. 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))
4. Age ≥18
5. 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, especially if >9h have elapsed, or in seriously ill patients (i.e., NIHSS>17). If a perfusion study is not available before MT, NCCT can still be used if the ASPECTS is ≥ 6.
6. Informed consent obtained from patient or acceptable patient surrogate.

Exclusion criteria 21

1. NIHSS score on admission >25
2. Contraindication to IV t‐PA as per local national guidelines (except time to therapy)
3. Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy during the first 24h
4. 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
5. Female who is pregnant or lactating or has a positive pregnancy test at time of admission
6. Current participation in another investigation drug or device treatment study
7. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
8. Known coagulopathy, or INR > 1.7
9. Platelets < 50,000
10. Renal Failure as defined by a serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate [GFR] < 30
11. Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason
12. Any hemorrhage on CT/MRI
13. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
14. Suspicion of aortic dissection
15. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol
16. History of life-threatening allergy (more than rash) to contrast medium
17. SBP >185 mmHg or DBP >110 mmHg refractory to treatment
18. Serious, advanced, terminal illness with anticipated life expectancy < 6 months
19. Pre-existing neurological or psychiatric disease that would confound evaluation
20. Presumed vasculitis or septic embolization
21. Unlikely to be available for 90-day follow-up (i.e., no fixed home address, visitor from overseas)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients with a mRS 0 to 1 at 90 days.

Secondary endpoints 1

1. •Proportion of patients with abnormal microvascular hypoperfusion on CT Perfusion at 36±24h post MT. • Volume of hypoperfusion on brain CTP at 36h±24h post MT •Infarct Expansion Ratio (IER): Final infarct to initial ischemic tissue volumes on brain NCCT at 36±24h post MT. •Barthel Scale score of 95 to 100, at day 90. •Quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 90 days. •The shift analysis of the modified Rankin Scale (mRS), at day 90.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Foundation Clinic For Biomedical Research

Sponsor organisation

Foundation Clinic For Biomedical Research

Address

Calle Rosellon 149-153

City

Barcelona

Postcode

08036

Country

Spain

Scientific contact point

Organisation

Foundation Clinic For Biomedical Research

Contact name

Dr. Ángel Chamorro

Public contact point

Organisation

Foundation Clinic For Biomedical Research

Contact name

Dr. Ángel Chamorro

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications