Efficacy and Safety Evaluation of 3K3A-APC in Ischemic Stroke (NCT05484154) | Clinical Trial Compass
WithdrawnPhase 3
Efficacy and Safety Evaluation of 3K3A-APC in Ischemic Stroke
Stopped: NIH funding suspension.
0Started 2024-10
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of intravenous doses of 3K3A-APC, a recombinant variant of human activated protein C (APC), in the treatment of acute ischemic stroke following treatment with thrombolysis, mechanical thrombectomy or both.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion Criteria:
* Acute ischemic stroke
* Able to receive thrombolysis, mechanical thrombectomy or both
* National Institutes of Health Stroke Scale (NIHSS) score of ≥ 5
* Signed informed consent
* Agreement to use effective birth control throughout the study
Exclusion Criteria:
* Neurologic deficit is non-disabling
* History of stroke or penetrating head injury within 90 days prior to enrollment
* History of previous or current diagnosis of intracranial hemorrhage
* Moyamoya disease, cerebral arteriovenous malformation, or known unsecured aneurysm requiring intervention during the acute study period
* Presence of tandem lesions suggesting a likely need for proximal artery stenting during the thrombectomy procedure that would mandate post-operative dual antiplatelet therapy
* Presence of other neurological or non-neurological co-morbidities, independently of the current stroke, that may lead to further deterioration in the subject's neurological status during the study period
* Prolonged prothrombin time (PT) or activated partial thromboplastin time (aPTT)
* Severe hypertension or hypotension
* Blood glucose concentration \< 50 mg/dL
* Prior exposure to any exogenous form of a recombinant variant of human APC
What they're measuring
1
To evaluate the effect of 3K3A-APC on 90-day disability