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Study Topics
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Sponsors and Collaborators: |
University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo Accumetrics, Inc. Helena Laboratories Point of Care Corgenix Medical Corporation Chrono-Log Corporation Siemens Healthcare Diagnostics Inc Haemonetics Corporation Diamed Corporation |
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Information provided by: | University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT00766896 |
STUDY QUESTIONS
PRIMARY OBJECTIVES
Hospital Phase (Acute Stroke)
Follow-up Phase
THE STUDY
PLATELET TESTS
Condition | Intervention | Phase |
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Stroke Cerebral Infarction Cardiovascular Diseases Vascular Diseases Atherosclerosis Ischemia Thrombosis Acute Coronary Syndrome |
Drug: Aspirin (platelet sensitive versus platelet hyperreactivity) |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Platelet Hyperreactivity to Aspirin and Stroke: A Prospective Study With Clinical Outcomes |
Estimated Enrollment: | 200 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Aspirin Sensitive: Active Comparator
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Drug: Aspirin (platelet sensitive versus platelet hyperreactivity)
The dose of aspirin to be prescribed in this study will be 300 mg orally or by nasogastric tube once a day (assisted therapy), with first dose tomography soon after admission if the patient has no indication of thrombolytic therapy. After the acute phase, patients will receive aspirin at a dose of 200 mg/day. Aspirin will be administered in a "simple" preparation (no buffer, no extended release).
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Platelet with hyperreactivity to aspirin: Active Comparator
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Drug: Aspirin (platelet sensitive versus platelet hyperreactivity)
The dose of aspirin to be prescribed in this study will be 300 mg orally or by nasogastric tube once a day (assisted therapy), with first dose tomography soon after admission if the patient has no indication of thrombolytic therapy. After the acute phase, patients will receive aspirin at a dose of 200 mg/day. Aspirin will be administered in a "simple" preparation (no buffer, no extended release).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Herlon S Martins, MD | 551130696922 | herlonsm@usp.br |
Contact: Irineu T Velasco, PHD | 551130696336 | velasco@usp.br |
Brazil, SP | |
Hospital das Clinicas, University of Sao Paulo, School of Medicine | Recruiting |
Sao Paulo, SP, Brazil, 05403000 | |
Contact: Herlon S Martins, MD 551130696922 herlonsm@usp.br | |
Contact: Irineu T Velasco, PHD 551130696336 velasco@usp.br | |
Principal Investigator: Herlon S Martins, MD |
Study Chair: | Herlon S Martins, MD | University of Sao Paulo, Hospital das Clinicas, Department of Emergency Medicine |
Study Chair: | Irineu T Velasco, PHD | University of Sao Paulo, Hospital das Clínicas, Department of Emergency Medicine |
Study Director: | Adriana B Conforto, PHD | University of Sao Paulo, Hospital das Clinicas, Department of Neurology |
Study Director: | Augusto Scalabrini-Neto, PHD | University of Sao Paulo, Hospital das Clínicas, Department of Emergency Medicine |
Study Director: | Élbio A D'Amico, PHD | University of Sao Paulo, Hospital das Clínicas, Department of Hematology |
Study Director: | Tânia RF Rocha, PHD | University of Sao Paulo, Hospital das Clínicas, Department of Hematology |
Study Director: | Moacyr RC Nobre, PHD | University of Sao Paulo, Unidade de Epidemiologia Clínica |
Study Director: | Eli F Evaristo, PHD | University of Sao Paulo, Hospital das Clínicas, Department of Neurology |
Study Director: | Fábio Yamamoto, PHD | University of Sao Paulo, Hospital das Clínicas, Department of Neurology |
Study Director: | Luíz R Comerlatti, MD | University of Sao Paulo, Hospital das Clínicas, Department of Neurology |
Study Director: | Felipe I Reis, MD | University of Sao Paulo, Hospital das Clínicas, Department of Emergency Medicine |
Study Director: | Cláudia C Leite, PHD | University of Sao Paulo, Hospital das Clínicas, Department of Radiology |
Study Director: | Alfonso Barbato, PHD | University of Sao Paulo, Hospital das Clínicas, Department of Radiology |
Study Director: | Milberto Scaff, PHD | University of Sao Paulo |
Responsible Party: | University of Sao Paulo ( Herlon Saraiva Martins ) |
Study ID Numbers: | 0292/07 |
Study First Received: | October 2, 2008 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00766896 |
Health Authority: | Brazil: National Committee of Ethics in Research; Brazil: Ethics Committee |
Stroke Cerebral Infarction Acute Coronary Syndrome Cardiovascular Diseases Vascular Diseases Platelet Activation |
Platelets Platelet Function Tests Aspirin Atherosclerosis Ischemia Thrombosis |
Atherosclerosis Arterial Occlusive Diseases Heart Diseases Cerebral Infarction Myocardial Ischemia Stroke Vascular Diseases Central Nervous System Diseases Ischemia Arteriosclerosis Brain Diseases |
Cerebrovascular Disorders Thrombosis Embolism and Thrombosis Necrosis Aspirin Embolism Acute Coronary Syndrome Brain Ischemia Brain Infarction Infarction |
Anti-Inflammatory Agents Disease Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Hematologic Agents Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions Fibrin Modulating Agents |
Pathologic Processes Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Syndrome Platelet Aggregation Inhibitors Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |