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This randomized clinical trial evaluated whether argatroban, a direct thrombin inhibitor, added to antiplatelet therapy improved neurological outcomes in patients with acute ischemic stroke who developed early neurological deterioration. A total of 628 patients were randomized to argatroban plus antiplatelet therapy or antiplatelet therapy alone. The primary endpoint was good neurological function at 90 days. Good neurological function was achieved in 80.5% of patients receiving argatroban plus antiplatelet therapy compared with 73.7% receiving antiplatelet therapy alone, an absolute difference of 6.8 percentage points. The corresponding odds ratio was 1.48 (95% CI, 1.01–2.16; P=0.04). The findings indicate a statistically significant improvement in the primary functional outcome with adjunctive argatroban in this selected population. The results support further evaluation of targeted anticoagulant therapy in patients with early neurological deterioration, but they should not be generalized to all patients with acute ischemic stroke or interpreted as establishing argatroban as routine treatment outside the studied clinical context.
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This randomized clinical trial evaluated whether argatroban, a direct thrombin inhibitor, added to antiplatelet therapy improved neurological outcomes in patients with acute ischemic stroke who developed early neurological deterioration. A total of 628 patients were randomized to argatroban plus antiplatelet therapy or antiplatelet therapy alone. The primary endpoint was good neurological function at 90 days. Good neurological function was achieved in 80.5% of patients receiving argatroban plus antiplatelet therapy compared with 73.7% receiving antiplatelet therapy alone, an absolute difference of 6.8 percentage points. The corresponding odds ratio was 1.48 (95% CI, 1.01–2.16; P=0.04). The findings indicate a statistically significant improvement in the primary functional outcome with adjunctive argatroban in this selected population. The results support further evaluation of targeted anticoagulant therapy in patients with early neurological deterioration, but they should not be generalized to all patients with acute ischemic stroke or interpreted as establishing argatroban as routine treatment outside the studied clinical context.
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