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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00533546 |
The purpose of this research study is to determine the safety and learn more about the dose of Activated Protein C (APC) in reducing the damage from stroke.
Condition | Intervention | Phase |
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Stroke |
Drug: Activated Protein C |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Activated Protein C in Acute Stroke Trial |
Estimated Enrollment: | 72 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive APC by intravenous injection.
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Drug: Activated Protein C
Intravenous APC (10, 15, 22, 33, 50, and 75 g/kg) administered to patients with acute ischemic stroke within 0 - 6 hours of symptom onset
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An ischemic stroke occurs when there is damage to the brain caused by blockage in the blood vessels supplying the brain. Approximately 500,000 people in the United States experience this type of stroke each year. The only approved treatment for acute stroke is to attempt to dissolve the blood clot using t-PA (tissue plasminogen activator). This treatment must be given within 3 hours of symptom onset and is associated with a risk of brain hemorrhage (bleeding in the brain) of about 6% (6 in 100 patients).
Activated Protein C (APC) is a protein in the blood that is important in dissolving blood clots and reducing inflammation. Studies in animals suggest that APC may also protect brain cells from injury caused by a stroke. We are doing this study to determine if giving APC to individuals who have had a stroke will be safe and will reduce the damage to brain cells caused by the stroke. APC is currently approved by the Food and Drug Administration (FDA) for use in patients with severe, life-threatening infections.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Curtis Benesch, MD, MPH | 585-275 2810 | Curtis_Benesch@urmc.rochester.edu |
Contact: Justine Zentner, MS, RN, ANP | 585-275-1204 | Justine_Zentner@urmc.rochester.edu |
United States, California | |
University of California Irvine Medical Center | Recruiting |
Orange, California, United States, 92868 | |
Contact: Camille Fitzpatrick, RN, NP 714-456-2260 fitzpatc@uci.edu | |
Principal Investigator: Vivek Jain, MD | |
United States, Missouri | |
Washington University--Barnes-Jewish Hospital | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Jill Newgent, RN 314-747-3795 newgentj@neuro.wustl.edu | |
Contact: Julie Rickmann 314-747-8794 rickmannj@neuro.wustl.edu | |
Principal Investigator: Jin-Moo Lee, MD, PhD | |
United States, New York | |
University of Rochester | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Ann Leonhardt, MS, ANP 585-275-2530 Ann_Leonhardt@urmc.rochester.edu | |
Principal Investigator: W. Scott Burgin, MD | |
Maimonides Medical Center | Recruiting |
Brooklyn, New York, United States, 11219 | |
Contact: Jill Slater, MS, NP 718-283-7670 jferkel@maimonidesmed.org | |
Principal Investigator: Steven H. Rudolph, MD | |
Mt. Sinai School of Medicine | Not yet recruiting |
New York, New York, United States, 10029 | |
Principal Investigator: Steven R Levine, MD | |
Rochester General Hospital | Recruiting |
Rochester, New York, United States, 14621 | |
Contact: Cheryl Weber, RN, MS, CCRC cheryl.weber@viahealth.org | |
Contact: Patricia Wallace, RN, BSN 585-922-5386 pat.wallace@viahealth.org | |
Principal Investigator: W. Scott Burgin, MD |
Study Chair: | Curtis Benesch, MD, MPH | University of Rochester |
Responsible Party: | University of Rochester ( Curtis Benesch, MD, MPH ) |
Study ID Numbers: | 537, 5R01HL080107-05 |
Study First Received: | September 19, 2007 |
Last Updated: | February 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00533546 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Acute Ischemic Stroke |
Drotrecogin alfa activated Anticoagulants Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Fibrinolytic Agents Cardiovascular Agents |
Ischemia Brain Diseases Cerebrovascular Disorders Fibrin Modulating Agents Protein C Brain Ischemia Brain Infarction Infarction |
Anticoagulants Molecular Mechanisms of Pharmacological Action Cerebral Infarction Stroke Nervous System Diseases Hematologic Agents Vascular Diseases Central Nervous System Diseases Fibrinolytic Agents Cardiovascular Agents |
Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Fibrin Modulating Agents Protein C Therapeutic Uses Brain Ischemia Cardiovascular Diseases Brain Infarction |