Safety Evaluation of 3K3A-APC in Ischemic Stroke "RHAPSODY"


Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Acute ischemic stroke
- Able to receive IV tPA, mechanical thrombectomy or both
- National Institutes of Health Stroke Scale (NIHSS) score of ≥ 5
- Signed informed consent
- Mechanical thrombectomy subjects only: onset time to arterial puncture time < 6 hours

Exclusion Criteria

- History of stroke or penetrating head injury within 90 days prior to enrollment
- History of previous or current diagnosis of intracranial hemorrhage that represents a potential for re-hemorrhage if subjected to thrombolytic therapy or mechanical thrombectomy
- Moyamoya disease, cerebral arterio-venous malformation (AVM), known unsecured aneurysm requiring intervention during the acute study period
- Presence of other neurological or non-neurological co-morbidities that may lead, independently of the current stroke, to further deterioration in the subject's neurological status during the trial period
- Presence of premorbid neurological deficits and functional limitations assessed by a retrospective Modified Rankin Scale (mRS) score of ≥ 2
- Mechanical thrombectomy subjects only: baseline non-contrast CT scan revealing a large core occlusion as defined by local protocol
- Prolonged prothrombin time (PT) or aPTT
- Severe hypertension or hypotension
- Glomerular filtration rate (GFR) <35 mL/min
- Blood glucose concentration < 50 mg/dL
- Prior exposure to any exogenous form of APC