Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261014
Status:
UNKNOWN
Last Update Posted:
2015-11-18
First Post:
2005-11-30
Brief Title:
Understanding Risk Factors Involved in Developing a Second Blood Clot
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
REcurrent VEnous Thromboembolism Risk Stratification Evaluation A Study to Develop a Clinical Prediction Rule to Predict Low Recurrence Risk in Patients With Idiopathic Venous Thromboembolism
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to develop a way to predict which patients diagnosed with idiopathic blood clots can safely stop warfarin therapy after six months We will use patient characteristics blood test results and imaging test results to identify those patients who have the lowest risk of developing a new blood clot after warfarin is stopped
Detailed Description:
The risk of recurrent VTE in patients with idiopathic VTE subsequent to three to six months of oral anticoagulant therapy remains high 5-27 per year The risk of recurrent VTE however is not likely high enough to justify indefinite anticoagulation in all patients with a first idiopathic VTE due to the rate of major bleeding with oral anticoagulants 2-6 per year the inconvenience and cost of oral anticoagulant therapy monitoring of oral anticoagulant therapy eg prescription costs time off work to go for lab tests parking etc and the lifestyle limitations of oral anticoagulant therapy avoidance of certain physical activities dietary restrictions avoidance of pregnancy Further as some have argued perhaps all that anticoagulant therapy achieves is to delay recurrent VTE and as a recent editorial suggested a tailored approached is required to determine sub-groups who require lifelong anticoagulation A means to stratify patients with idiopathic VTE to identify a group at low risk of recurrent VTE who could safely discontinue oral anticoagulants subsequent to six months of therapy would be a significant advance in the care of these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None