CompletedPhase 1/2

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

Australia, Austria, France40 participantsStarted 2009-11

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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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

What they're measuring

Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort

Timeframe: 90 days

Trial details

NCT IDNCT01014975

SponsorGrifols Therapeutics LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

Results submitted2015-08-20

View on ClinicalTrials.gov More Acute Ischemic Stroke trials