Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266045
Status:
COMPLETED
Last Update Posted:
2021-03-19
First Post:
2005-12-13
Brief Title:
D-dimer Levels During and After Anticoagulation in Patients With a Previous Venous Thromboembolism Effects on the Risk of Recurrence
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study Overview
Official Title:
A Multicentre Prospective Observational Study on the Predictive Role for Recurrence of D-dimer Levels Measured During and After Anticoagulation in Patients With a First Venous Thromboembolism Episode the PROLONG-II Study
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
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 results of the Prolong study currently submitted for publication show that patients with a first unprovoked venous thromboembolic event who have altered D-dimer levels measured one month after anticoagulation with vitamin K antagonists is stopped have a high rate of recurrences about 14 and a prolongation of anticoagulation is effective in reducing significantly this rate Those patients with normal D-dimer about 60 of all patients examined have a low rate of recurrences about 5 and likely a prolongation of anticoagulation in all these patients cannot be recommended
In line with these results the Prolong-Two study aims at assessing the predictive role for recurrence of D-dimer levels measured a during anticoagulation b one month after its withdrawal and c periodically during follow up
Patients with a first unprovoked venous thromboembolism including proximal deep vein thrombosis of a leg andor pulmonary embolism which are treated with vitamin K antagonists for not less than 6 months are considered for the study D-dimer assay is performed during anticoagulation and patients with altered results continue the anticoagulation for 6 more months Those with normal D-dimer stop the anticoagulant treatment and are again examined one month later Anticoagulation is resumed for 6 more months in those patients with abnormal D-dimer results but is permanently stopped in those with a normal assay The latter patients are examined and D-dimer assay performed again every two months to evaluate the natural history of the assay after anticoagulation is stopped and the possible predictive value for recurrence of a change of the assay during follow-up from normal to abnormal results
In line with these results the Prolong-Two study aims at assessing the predictive role for recurrence of D-dimer levels measured a during anticoagulation b one month after its withdrawal and c periodically during follow up
Patients with a first unprovoked venous thromboembolism including proximal deep vein thrombosis of a leg andor pulmonary embolism which are treated with vitamin K antagonists for not less than 6 months are considered for the study D-dimer assay is performed during anticoagulation and patients with altered results continue the anticoagulation for 6 more months Those with normal D-dimer stop the anticoagulant treatment and are again examined one month later Anticoagulation is resumed for 6 more months in those patients with abnormal D-dimer results but is permanently stopped in those with a normal assay The latter patients are examined and D-dimer assay performed again every two months to evaluate the natural history of the assay after anticoagulation is stopped and the possible predictive value for recurrence of a change of the assay during follow-up from normal to abnormal results
Detailed Description:
None
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