Safety Evaluation of 3K3A-APC in Ischemic Stroke

Completed · Phase 2 · Has a placebo group

Conditions studied: Ischemic Stroke

In brief

The purpose of this study was to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human activated protein C (APC), in in the treatment of acute ischemic stroke following treatment with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.

Key facts

Study ID

NCT02222714

Run by

ZZ Biotech, LLC

People needed

110

Starts

2014-10-01

Expected to finish

2017-06-29

Last updated by the study team

2018-11-08

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 activated partial thromboplastin time (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

Where it is running

• Stroke Center — Los Angeles, California, United States
• Stroke Center — Chicago, Illinois, United States
• Stroke Center — Kansas City, Kansas, United States
• Stroke Center — Boston, Massachusetts, United States
• Stroke Center — St Louis, Missouri, United States
• Stroke Center — Buffalo, New York, United States
• Stroke Center — New York, New York, United States
• Stroke Center — Rochester, New York, United States
• Stroke Center — Cincinnati, Ohio, United States
• Stroke Center — Columbus, Ohio, United States
• Stroke Center — Pittsburgh, Pennsylvania, United States
• Stroke Center — Nashville, Tennessee, United States
• Stroke Center — Dallas, Texas, United States
• Stroke Center — Salt Lake City, Utah, United States
• Stroke Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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