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Patient Safety in Trials of Therapy for Acute Ischemic Stroke
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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To the Editor: In their Editorial accompanying the report of our trial of aptiganel for acute ischemic stroke,1 Drs Becker and Tirschwell2 make a number of important and valid points. However, several of their inferences about our study were based on incomplete information and thus require clarification.
First, the authors were concerned that patients enrolled in the study were not informed about the availability of thrombolytic therapy. After the US Food and Drug Administration approved intravenous tissue plasminogen activator (t-PA) for patients with ischemic stroke who could be treated within 3 hours of symptom onset, the informed consent of our study was modified to reflect this new information. There was no intent to deprive patients of any treatment (including intravenous t-PA) that their physicians deemed appropriate. Patients who were treated with t-PA were precluded from participation in the trial because of concern of untoward drug interactions. Treating physicians decided whether . . . [Full Text of this Article]
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Ensuring Patient Safety in Clinical Trials for Treatment of Acute Stroke
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