PROACT II
Prolyse in Acute Cerebral Thromboembolism II
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Status:
PROACT trial (Phase II) reported in Stroke 29:4-11, 1998. PROACT II (Phase III trial) commenced Feb 1996 and completed 8/98 at 54 centers in North America. Results presented at AHA meetings 2/99, final report published 11/99.
Purpose:
To determine the clinical efficacy and safety of intra-arterial recombinant prourokinase in patients with acute MCA stroke of less than 6 hours duration.
Interventions:
Prourokinase
Thrombolytic agent (urokinase pro-drug, recombinant)
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Location(s):
U.S. and Canada
Year Started:
1996
Year Finished:
1998
Year Presented:
1999
Design:
Phase III, randomized, controlled, multicenter, open-label clinical trial with blinded follow-up involving 180 patients at 54 centers in the U.S. and Canada.
Inclusion Criteria
Patients with acute ischemic stroke of less than 6 hours duration caused by angiographically proven occlusion of the middle cerebral artery (MCA, M1 or M2), National Institutes of Health Stroke Scale (NIHSS) score of at least 4 (except for isolated aphasia or hemianopia). Aged 18-85 years.
Exclusion Criteria
NIHSS>30, rapid improvement, history of stroke within previous 6 weeks, seizures at onset, clinical presentation suggestive of subarachnoid hemorrhage, previous history or intracranial hemorrhage at any time, neoplasm, or subarachnoid hemorrhage, septic embolism, suspected lacunar stroke, surgery, biopsy of a parenchymal organ, trauma with internal injuries or lumbar puncture within 30 days, head trauma within 90 days, active or recent hemorrhage within 30 days, known hemorrhagic diathesis, known contrast sensitivity, sustained BP > 180/100, INR > 1.7, hemorrhage or major early infarction signs on CT scan.
Patient Involvement:
Patients were randomized to receive local intraarterial (IA) recombinant prourokinase (r-pro-UK, 9 mg over 120 min) plus IV low-dose heparin (n=121) vs low-dose heparin alone (n=59). All subjects had repeat angiography to assess recanalization.
Primary Outcome:
Proportion of patients with slight or no neurologic disability at 90 days, as defined by a modified Rankin score of 2 or less.
Secondary Outcome:
MCA recanalization, frequency of symptomatic intracranial hemorrhage with neurologic deterioration, and mortality.
Results:
Modified Rankin score 0-2 at 90 days: treatment 40%, control 25% (p=0.04). Recanalization rate: treatment 66% (most partial recanalization), control 18% (p<.001). ICH with neurological deterioration within 24 hours occurred in 10.9% of r-pro-UK group and 3.1% of control group (p=.06). Overall mortality not different: r-proUK 25%, control 27% (ns).
Source of Information:
Presented at the 24th International Joint Conference on Stroke and Cerebral Circulation (February 1999). Published results.
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Web Links and Publications:
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This information last updated on: 8/27/2008
Reviewed on: 08/27/2008.
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