- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00720915
D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months (DODS)
December 12, 2016 updated by: McMaster University
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
410
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 3Z5
- McMaster University
-
Hamilton, Ontario, Canada, L8L 2X2
- Hamilton General Hospital
-
Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Health Care Centre
-
Hamilton, Ontario, Canada, L8V1C3
- Henderson Hospital
-
-
-
-
-
Limerick, Ireland
- Limerick, Mid Western Regional Hospital
-
-
-
-
-
Cambridge, United Kingdom, B2 0QQ
- Addenbrooke's Hospital
-
-
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20057
- Lombardi Cancer Center
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Centre
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599-7035
- UNC Thrombophilia Program
-
-
Utah
-
Murray, Utah, United States, 84152
- Intermountain Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be >= 18 years of age
- Have had ONE episode of unprovoked proximal DVT and/or PE
- Have completed 3 uninterrupted months of warfarin therapy (target INR of 2.0-3.0)
Exclusion Criteria:
- Another indication for long-term anticoagulation (e.g., atrial fibrillation)
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 mumols /litre (1.7 mg/dl)
- Known chronic liver disease with a total bilirubin of more than 25 mumols /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)
- A vena caval filter
- Has had D-dimer testing performed within 2 months of potential enrollment other than for evaluation of suspected recurrent VTE that was not confirmed
- Has a life expectancy less than 5 years
- Is unable to attend follow-up visits because of geographic inaccessibility
- Is participating in a competing clinical investigation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: No Anticoagulant Therapy
|
Patients with negative d-dimer discontinue long-term anticoagulant therapy.
|
Other: Anticoagulant Therapy
Continue on anticoagulant therapy
|
Patients with positive d-dimer continue or re-start on anticoagulant therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Suspected Recurrent DVT
Time Frame: up to 7 years
|
up to 7 years
|
Suspected (recurrent) pulmonary embolism
Time Frame: up to 7 years
|
up to 7 years
|
Bleeding
Time Frame: up to 7 years
|
up to 7 years
|
Death
Time Frame: up to 7 years
|
up to 7 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Clive Kearon, MB MRCP(I) FRCP(C) PhD, McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kearon C, Parpia S, Spencer FA, Schulman S, Stevens SM, Shah V, Bauer KA, Douketis JD, Lentz SR, Kessler CM, Connors JM, Ginsberg JS, Spadafora L, Julian JA. Long-term risk of recurrence in patients with a first unprovoked venous thromboembolism managed according to d-dimer results; A cohort study. J Thromb Haemost. 2019 Jul;17(7):1144-1152. doi: 10.1111/jth.14458. Epub 2019 May 20.
- Kearon C, Parpia S, Spencer FA, Baglin T, Stevens SM, Bauer KA, Lentz SR, Kessler CM, Douketis JD, Moll S, Kaatz S, Schulman S, Connors JM, Ginsberg JS, Spadafora L, Bhagirath V, Liaw PC, Weitz JI, Julian JA. Antiphospholipid antibodies and recurrent thrombosis after a first unprovoked venous thromboembolism. Blood. 2018 May 10;131(19):2151-2160. doi: 10.1182/blood-2017-09-805689. Epub 2018 Feb 28.
- Kearon C, Spencer FA, O'Keeffe D, Parpia S, Schulman S, Baglin T, Stevens SM, Kaatz S, Bauer KA, Douketis JD, Lentz SR, Kessler CM, Moll S, Connors JM, Ginsberg JS, Spadafora L, Julian JA; D-dimer Optimal Duration Study Investigators. D-dimer testing to select patients with a first unprovoked venous thromboembolism who can stop anticoagulant therapy: a cohort study. Ann Intern Med. 2015 Jan 6;162(1):27-34. doi: 10.7326/M14-1275.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
July 21, 2008
First Submitted That Met QC Criteria
July 21, 2008
First Posted (Estimate)
July 23, 2008
Study Record Updates
Last Update Posted (Estimate)
December 13, 2016
Last Update Submitted That Met QC Criteria
December 12, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Embolism and Thrombosis
- Embolism
- Thrombosis
- Venous Thrombosis
- Pulmonary Embolism
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Fibrin fragment D
- Anticoagulants
Other Study ID Numbers
- CTMG-2007-DODS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Deep Vein Thrombosis
-
University of OklahomaPfizerCompleted
-
University Medical Center GroningenCompletedSuspected Upper Extremity Deep Vein ThrombosisAustria, Netherlands, Italy, Belgium, Switzerland, Germany, United States
-
National Taiwan University HospitalUnknownUpper Extremity Deep Vein Thrombosis, SecondaryTaiwan
-
University of Missouri-ColumbiaTerminatedDEEP VEIN THROMBOSISUnited States
-
Vetex Medical Ltd.CompletedDeep Vein Thrombosis LegIreland, Germany, Bulgaria, United Kingdom
-
MinaPharm PharmaceuticalsRecruitingProphylaxis of Deep Vein ThrombosisEgypt
-
McMaster UniversityCanadian Institutes of Health Research (CIHR)CompletedSuspected Deep Vein ThrombosisCanada
-
Diakron PharmaceuticalsCompleted
-
UPECLIN HC FM Botucatu UnespCompletedProphylaxis of Deep Vein ThrombosisBrazil
-
BayerRecruitingThrombolysis | Symptomatic Proximal Deep Vein ThrombosisBelgium, France, Italy, Netherlands, Canada, Germany
Clinical Trials on Discontinue anticoagulant therapy (Negative d-dimer)
-
3MTerminatedWounds and Injuries | Wound Healing | Granulation TissueUnited States
-
Wuhan Asia Heart HospitalActive, not recruitingHemorrhage | Thrombosis | Extracorporeal Membrane Oxygenation Complication | Heparin OverdoseChina
-
Medical University of GrazCompletedCritical Illness | Covid19 | Risk Factor, Cardiovascular | Course IllnessAustria
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingGlioblastoma | GliosarcomaUnited States
-
National Cancer Institute (NCI)NRG Oncology; Radiation Therapy Oncology GroupCompletedGlioblastoma | Gliosarcoma | Supratentorial GlioblastomaUnited States, Canada, Israel
-
Jonsson Comprehensive Cancer CenterParker Institute for Cancer ImmunotherapyRecruitingRecurrent Mantle Cell Lymphoma | Recurrent Small Lymphocytic Lymphoma | Recurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Refractory Chronic Lymphocytic Leukemia | CD20 Positive | Refractory Mantle Cell Lymphoma | Recurrent Chronic Lymphocytic Leukemia | Refractory... and other conditionsUnited States
-
Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG OncologyActive, not recruitingStage II Non-Small Cell Lung Cancer AJCC v7 | Stage IIA Non-Small Cell Lung Carcinoma AJCC v7 | Stage IIB Non-Small Cell Lung Carcinoma AJCC v7 | Stage IIIA Non-Small Cell Lung Cancer AJCC v7 | Stage III Non-Small Cell Lung Cancer AJCC v7 | Stage IIIB Non-Small Cell Lung Cancer AJCC v7United States
-
M.D. Anderson Cancer CenterCompletedInvasive Breast Carcinoma | Triple-Negative Breast CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingMetastatic Malignant Neoplasm in the Liver | Advanced Malignant Neoplasm | Refractory Malignant Neoplasm | Colorectal Carcinoma Metastatic in the LiverUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingNeuroblastoma | Ganglioneuroblastoma, NodularUnited States, Australia, Canada, New Zealand