Phase 2 Completed N=40 Treatment

A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients

Source: ClinicalTrials.gov NCT01014975 ↗

Enrolled (actual)

Serious AEs

50.0%

Results posted

Oct 2015

Primary outcomePrimary: Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort — 0; 0; 0 participants

Summary

This study tests the drug, Plasmin (Human), in patients with a stroke due to a clot in the middle cerebral artery (MCA). Plasmin is an enzyme that causes clot lysis by cleaving a clot component, fibrin. In this study, Plasmin (Human) is administered locally through a catheter to the clot within 9 hours of the stroke onset. Three doses of Plasmin (Human) (20 mg, 40 mg, and 80 mg) are being tested in 3 different groups of patients. Patients are monitored by imaging of the affected artery and functional testing.

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort	0; 0; 0	—

Eligibility Criteria

Inclusion Criteria

18 to 85 years of age
Male or female
New focal, potentially disabling neurologic deficit clinically localized to the MCA distribution
Intra-arterial therapy with Plasmin completed within 9 hours of stroke onset
A National Institutes of Health Stroke Scale score ≥ 4 and ≤ 25

Exclusion Criteria

Intracranial procedures or intracranial or systemic bleeding within the last year
Intracranial neoplasm (except meningioma), septic embolism, or unsecured aneurysm
Active bleeding
History of stroke in previous 6 weeks
Uncontrolled hypertension
Renal disease or renal dialysis
Treatment with any plasminogen activator within the last 48 hrs.
Therapy with a Glycoprotein IIb/IIIa inhibitor in 5 days prior to study enrollment or at any time during study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01014975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.