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Sponsors and Collaborators: |
University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) |
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Information provided by: | University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT00621491 |
The purpose of this study is to evaluated whether prophylactic treatment with six-month use of warfarin could prevent transvenous leads-associated thrombosis in high risk patients.
Condition | Intervention | Phase |
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Venous Thrombosis Postoperative Complications |
Drug: Warfarin |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Controlled Clinical Trial for the Prevention of Thromboembolic Complications After Transvenous Cardiac Devices Implantation in High Risk Patients |
Estimated Enrollment: | 200 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: Warfarin
Single daily dose of Warfarin (5 mg/orally), adjusted to achieve an International Normalized Ratio (INR) between 2 to 3.5 times the normal value during six months
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Pacemaker and defibrillator transvenous leads frequently cause venous lesions, such as stenosis, occlusion or thrombosis. Previous temporary transvenous leads ipsilateral to the permanent implantation and lower left ventricular ejection fraction (LVEF) were associated with an increased risk of obstructions. The effect of prophylactic strategies to prevent these lesions remains controversial. Thus, the aim of this prospective, clinical, randomized, controlled and blinded study is evaluate whether prophylactic treatment with six-month use of warfarin could prevent transvenous leads-associated thrombosis in high risk patients. After device implantation, patients are randomly assigned to placebo or warfarin. Periodical clinical and laboratorial evaluations are performed to anticoagulant management. Following the six-month period, all patient are submitted to a digital subtraction venography and the prophylactic treatment will be discontinued.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Katia R Silva, Nurse | 55-11-3069-5284 | katia.regina@incor.usp.br |
Contact: Roberto Costa, MD PhD | 55-11-3082-2130 | rcosta@incor.usp.br |
Brazil, SP | |
Heart Institute (InCor) - Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo | Recruiting |
Sao Paulo, SP, Brazil, 05403-900 | |
Contact: Katia R Silva, Nurse 55-11-3069-5284 katia.regina@incor.usp.br | |
Contact: Roberto Costa, MD PhD 55-11-3082-2130 rcosta@incor.usp.br | |
Sub-Investigator: Katia R Silva, Nurse | |
Principal Investigator: Roberto Costa, MD PhD | |
Sub-Investigator: Martino Martinelli Filho, MD PhD | |
Sub-Investigator: Roberto A Rached, MD PhD | |
Sub-Investigator: Silvana D Nishioka, MD PhD | |
Sub-Investigator: Cyrillo Cavalheiro Filho, MD PhD | |
Sub-Investigator: José Guilherme MP Caldas, MD PhD | |
Sub-Investigator: Francisco C Carnevale, MD PhD |
Study Chair: | Roberto Costa, MD PhD | University of Sao Paulo |
Principal Investigator: | Katia R Silva, Nurse | University of Sao Paulo |
Responsible Party: | Heart Institute (Incor) - Hospital das Clínicas da Faculdade de Medicina ( Roberto Costa/ MD PhD ) |
Study ID Numbers: | SDC 2273/03/067 |
Study First Received: | February 11, 2008 |
Last Updated: | February 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00621491 |
Health Authority: | Brazil: University of Sao Paulo |
Venous Thrombosis Cardiac Pacing Postoperative Complications Anticoagulants Clinical Trials |
Embolism and Thrombosis Postoperative Complications Embolism Vascular Diseases |
Venous Thrombosis Warfarin Thrombosis |
Anticoagulants Pathologic Processes Therapeutic Uses |
Hematologic Agents Cardiovascular Diseases Pharmacologic Actions |