В продолжение:
The Desmoteplase in Acute Ischemic Stroke Trial (DIAS). A Phase II MRI-Based 9-Hour Window Acute Stroke Thrombolysis Trial With Intravenous Desmoteplase.Stroke. Jan 2005;36:66-73.
Desmoteplase In Acute ischemic Stroke (DIAS).
Ongoing Clinical Trials Session, 28th International Stroke Conference, 2003 [PDF Format]
DIAS-2
Desmoteplase in Acute Ischemic Stroke-2
Status
Trial is in the planning stages.
Purpose
To deterine the safety and efficacy of recombinant desmoteplase in acute ischemic stroke.
Intervention(s)
Desmoteplase (Thrombolytic agent; reportedly selective for fibrin-bound plasminogen)
Study Size Planned: 186
Maximum time from onset: 9 hours
Design
Study Design: Randomized, double-blind, placebo-controlled, dose-ranging trial.
Inclusion Criteria: Stable ischemic stroke, NIHSS score between 4 and 20, ability to treat within 3-9 hours of stroke onset.
Patient Involvement: Patients will be randomized to receive either placebo, or one of two doses of desmoteplase (90 µ/kg or 125 µ/kg).
Primary Outcome: Safety endpoint is the frequency of symptomatic intracranial hemorrhage. Efficacy endpoint is infarct volume at 90 days (as measured by MRI).
Secondary Outcome(s): 90 day clinical outcome as measured by NIHSS, modified Rankin, and Barthel Index scores.
Source of Information
Paion press release.
Web Links and Publications
Paion Gmbh
DEDAS
Dose escalation study of desmoteplase in acute ischemic stroke
Status
Enrollment concluded in November of 2004 with 38 patients. Follow-up is ongoing. (Note: This is the US twin study to the DIAS trial.)
Purpose
To assess the safety and thrombolytic efficacy of intravenous desmoteplase (vampire bat plasminogen activator) in patients with acute ischemic stroke.
Intervention(s)
Desmoteplase (Thrombolytic agent; reportedly selective for fibrin-bound plasminogen)
Trial Location(s) United States
Study Size Actual: 38
Number of Centers 15
Ages Eligible: 18-85
Maximum time from onset: 9 hours
Design
Study Design: Multicenter, multinational, double-blind, placebo-controlled, randomized Phase II trial.
Inclusion Criteria: Patients between 18 and 85 years of age, who are between 3 and 9 hours post-ischemic stroke, who score between 4 and 20 on the National Institute of Health Stroke Scale (NIHSS) and show signs of cortical involvement, who receive MRI screening within 8 hours of their strokes that show a perfusion-weighted imaging (PWI) abnormality =< 2 cm in diameter in the hemispheric gray matter, that also either shows no diffusion-weighted imaging (DWI) abnormality, or a PWI/DWI mismatch > 20%, are eligible for the study.
Exclusion Criteria: Females of childbearing potential, persons who weigh < 50 kg (110 lbs), who are ineligible to receive medication within 30 minutes of their MRI, whose strokes are idiopathic, who have a prestroke modified Rankin score (MRS) > 1, who have a history of intracranial hemorrhage (ICH), subarachnoid hemorrhage (SAH), arteriovenous malformation, or aneurysm, whose clinical presentation suggests SAH, who use oral anticoagulants or have an international normalized ratio (INR) > 1.7, who have received heparin within 48 hours or who have a partial thromboplastin time (PTT) > 1.5 times the normal value, who use glycoprotein Iib/IIIa inhibitors, or who have any condition that would confer additional risk while receiving trial medication, will be excluded from the study.
Patient Involvement: Upon admission, prospective participants will undergo a complete history and physical, an MRI, laboratory tests, and other trial-related assessments in order to determine trial eligibility. Desmoteplase will be administered to participants in a single-bolus IV infusion. Patients will undergo 11 assessments during the 3-month trial, in addition to another assessment upon discharge from the hospital.
Primary Outcome: The 90-day clinical outcome, determined by NIHSS, MRS, Barthel Index (BI) scores, and mortality rates, as well as the 30-day biological outcome, measured in areas of PWI and DWI deficits on MRI, PWI/DWI mismatch, change in reperfusion of the affected artery at 4-8 h from baseline (assessed by MRA, magnetic resonance angiography), and incidence of symptomatic ICH.
Source of Information
Correspondence from Paion.
Web Links and Publications
Paion Gmbh