Phase 2
N=40
A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients
Acute Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01014975 ↗Enrolled (actual)
40
Serious AEs
50.0%
Results posted
Oct 2015
Primary outcome: Primary: Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort — 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Plasmin (Human) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Grifols Therapeutics LLC
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort |
0; 0; 0 | — |
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.
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
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.