DRKS00025976
Completed
Phase 2
A Double-Blind, Placebo-Controlled, Randomized, Phase Ib/IIa Clinical Study of ApTOLL for the Treatment of Acute Ischemic Stroke - APRI
AptaTargets S. L.0 sites151 target enrollmentAugust 3, 2021
ConditionsStroke
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- AptaTargets S. L.
- Enrollment
- 151
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \=18 and \=90 years.
- •2\. Informed consent obtained from subject or acceptable
- •subject surrogate (i.e. next of kin, or legal representative).
- •3\. A new focal disabling neurologic deficit consistent with
- •acute cerebral ischemia.
- •4\. Baseline NIHSS obtained prior to randomization \= 8 points and \= 25 points.
- •5\. Pre\-stroke mRS score of 0 \- 2\.
- •6\. Treatable as soon as possible and at least within 6 h of symptom onset, defined as point in time when the subject was last seen well (at baseline).
- •(Treatment start is defined as
- •study drug administration.)
Exclusion Criteria
- •1\. Subject has suffered a stroke in the past 1 year.
- •2\. Occlusion (TICI 0 or TICI 1 flow) of the basilar or vertebral or posterior or anterior cerebral arteries.
- •3\. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- •4\. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \>3\.0\.
- •5\. Baseline platelet count \<50,000/µL.
- •6\. Baseline blood glucose of \<50 mg/dL or \>400 mg/dL.
- •7\. Severe, sustained hypertension (systolic blood pressure\>185 mmHg or diastolic blood pressure \>110 mmHg). NOTE: If the blood pressure can be successfully reduced and maintained at an acceptable level using European Stroke Organization (ESO ) guidelines recommended medication (including i.v. antihypertensive drips), the patient can be enrolled.
- •8\. Serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year.
- •9\. Subjects with identifiable intracerebral tumors (meningioma is considered extracerebral tumor, so it is not included in this exclusion criterium).
- •10\. History of life\-threatening allergy (more than rash ) to contrast medium.
Outcomes
Primary Outcomes
Not specified
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