Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Phase Ib/IIa Clinical Study of ApTOLL for the Treatment of Acute Ischemic Stroke

Lead Sponsor:

aptaTargets S.L.

Collaborating Sponsors:

Ministry of Science and Innovation, Spain

Anagram

Conditions:

Stroke

Acute Stroke

Eligibility:

All Genders

18-90 years

Phase:

PHASE1

PHASE2

Brief Summary

This is a prospective, multicenter, double-blind, randomized, placebo-controlled, Phase Ib/IIa clinical study to assess the administration of ApTOLL together with endovascular therapy in acute ischemi...

Detailed Description

This is a prospective, multicenter, double-blind, randomized, placebo-controlled, Phase Ib/IIa clinical study to assess the administration of ApTOLL together with endovascular therapy in acute ischemi...

Eligibility Criteria

Inclusion

  • Age ≥18 and ≤90 years.
  • Informed consent obtained from subject or acceptable subject surrogate (i.e. next of kin, or legal representative).
  • A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
  • Baseline NIHSS obtained prior to randomization ≥ 8 points and ≤ 25 points.
  • Pre-stroke mRS score of 0 - 2.
  • Treatable as soon as possible and at least within 6 hours of symptom onset, defined as point in time when the subject was last seen well (at baseline).
  • Patients should be candidates to receive EVT treatment with or without i.v. rt-PA.
  • Occlusion (TICI 0 or TICI 1 flow), of the terminal internal carotid artery (TICA), M1 or M2 segments of the middle cerebral artery, suitable for mechanical embolectomy, confirmed on Computed Tomography Angiography.
  • The following imaging criteria should also be met on admission neuroimaging:
  • MRI criterion: volume of DWI (Diffusion-weighted Imaging) restriction ≥5 mL and ≤70 mL OR
  • CT criterion: Alberta Stroke program early CT score (ASPECTS) 6 to 10 on baseline CT AND infarct core determined on admission CTPerfusion by Cerebral Blood Flow\<30%: ≥5 mL and ≤70 mL.
  • The subject has an indication and is planned to receive endovascular treatment of stroke according to the European Stroke Organization Guidelines.

Exclusion

  • Subject has suffered a stroke in the past 1 year.
  • Occlusion (TICI 0 or TICI 1 flow) of the basilar or vertebral or posterior or anterior cerebral arteries.
  • Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
  • Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR (international normalized ratio)\>3.0.
  • Baseline platelet count \<50,000/μL.
  • Baseline blood glucose of \<50 mg/dL or \>400 mg/dL.
  • Severe, sustained hypertension (systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg).
  • Serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year.
  • Subjects with identifiable intracranial tumors.
  • History of life-threatening allergy (more than rash) to contrast medium.
  • Known renal insufficiency with creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) \<30 mL/min.
  • Cerebral vasculitis.
  • Evidence of active systemic infection.
  • Known current use of cocaine at time of treatment.
  • Patient participating in a study involving an investigational drug or device that would impact this study.
  • Patients that are unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas).
  • Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
  • CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
  • Significant mass effect with midline shift.
  • Suspicion of aortic dissection presumed septic embolus, or suspicion of bacterial endocarditis.

Key Trial Info

Start Date :

October 28 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 7 2022

Estimated Enrollment :

151 Patients enrolled

Trial Details

Trial ID

NCT04734548

Start Date

October 28 2020

End Date

September 7 2022

Last Update

October 21 2022

Active Locations (16)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (16 locations)

1

Centre Hospitalier Régional Universitaire de Lille

Lille, France

2

Foundation Adolphe de Rothschild

Paris, France

3

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

4

Universitätsklinikum Essen

Essen, Germany