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Trial NCT00720915

Resource URI: http://static.linkedct.org/resource/trials/NCT00720915
PropertyValue
linkedct:acronym DODS
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/30567>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/36690>
linkedct:brief_title D-dimer to Select Patients With a First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:condition <http://static.linkedct.org/resource/condition/10998>
linkedct:condition <http://static.linkedct.org/resource/condition/3612>
linkedct:criteria Inclusion Criteria: 1. Be >= 18 years of age 2. Have had ONE episode of unprovoked proximal DVT and/or PE 3. Have completed 3 uninterrupted months of warfarin therapy (target INR of 2.0-3.0) Exclusion Criteria: 1. Another indication for long-term anticoagulation (e.g., atrial fibrillation) 2. A high risk of bleeding as evidenced by any of the following: - Age greater than 75 years - Previous episode of major bleeding where the cause was not effectively treated - Known chronic thrombocytopenia with a platelet count of less than 120,000 x 10^9 /L - Known chronic renal impairment with a creatinine of more than 150 umols/litre (1.7 mg/dl) - Known chronic liver disease with a total bilirubin of more than 25 umols/litre (1.5 mg/dl) - Active peptic ulcer disease - Poor compliance with, or control of, anticoagulant therapy during initial treatment - Requires dual antiplatelet therapy (e.g. aspirin and clopidogrel) 3. A vena caval filter 4. Has had D-dimer testing performed within 2 months of potential enrollment other than for evaluation of suspected recurrent VTE that was not confirmed 5. Has a life expectancy less than 5 years 6. Is unable to attend follow-up visits because of geographic inaccessibility 7. Is participating in a competing clinical investigation
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date August 2012
linkedct:enrollment 400 (xsd:int)
linkedct:firstreceived_date July 21, 2008
linkedct:has_dmc Yes
linkedct:id NCT00720915
linkedct:intervention <http://static.linkedct.org/resource/intervention/47313>
linkedct:intervention <http://static.linkedct.org/resource/intervention/47316>
rdfs:label Trial NCT00720915
linkedct:lastchanged_date November 6, 2009
linkedct:lead_sponsor_agency McMaster University
linkedct:location <http://static.linkedct.org/resource/location/128400>
linkedct:location <http://static.linkedct.org/resource/location/131528>
linkedct:location <http://static.linkedct.org/resource/location/147597>
linkedct:location <http://static.linkedct.org/resource/location/148201>
linkedct:location <http://static.linkedct.org/resource/location/161820>
linkedct:location <http://static.linkedct.org/resource/location/186923>
linkedct:location <http://static.linkedct.org/resource/location/188325>
linkedct:location <http://static.linkedct.org/resource/location/19618>
linkedct:location <http://static.linkedct.org/resource/location/19772>
linkedct:location <http://static.linkedct.org/resource/location/19822>
linkedct:location <http://static.linkedct.org/resource/location/19920>
linkedct:location <http://static.linkedct.org/resource/location/207227>
linkedct:location <http://static.linkedct.org/resource/location/333094>
linkedct:location <http://static.linkedct.org/resource/location/73285>
linkedct:nct_id NCT00720915
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Cohort Study to Test That There is a Low Risk of Recurrent VTE in Patients With a First Episode of Unprovoked VTE Who Stop Anticoagulant Therapy After 3 Months of Treatment in Response to Negative D-dimer Testing
linkedct:org_study_id CTMG-2007-DODS
linkedct:overall_contact_email stewartc@mcmaster.ca
linkedct:overall_contact_last_name Clare Stewart, M.A.
linkedct:overall_contact_phone 905-527-2299
linkedct:overall_contact_phone_ext 43791
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10325>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/415>
foaf:page <http://clinicaltrials.gov/show/NCT00720915>
linkedct:phase N/A
linkedct:primary_completion_date August 2012
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/76179>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/76180>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/76181>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/76182>
linkedct:source McMaster University
linkedct:start_date September 2008
linkedct:study_design Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to determine if the risk of recurrent venous thromboembolism (VTE) after stopping therapy is low and acceptable in patients with a first unprovoked proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) who have completed 3 months of therapy and who have a negative D-dimer test on therapy and 1 month after stopping therapy.
rdf:type linkedct:trials
linkedct:verification_date November 2009