Ignite Creation Date:
2024-05-06 @ 2:31 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02066662
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2014-02-17
Brief Title:
Rivaroxaban Compared to Vitamin K Antagonist Upon Development of Cardiovascular Calcification
Sponsor:
RWTH Aachen University
Organization:
RWTH Aachen University
Study Overview
Official Title:
Influence of Rivaroxaban Compared to Vitamin K Antagonist Treatment Upon Development of Cardiovascular Calcification in Patients With Atrial Fibrillation and or Pulmonary Embolism IRIVASC- Trial
Status:
COMPLETED
Status Verified Date:
2020-10
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 following trial hypothesis will be proved In patients with atrial fibrillation and or pulmonary embolism standard anticoagulant treatment with coumadinphenprocoumon is associated with accelerated coronary or valvular calcification as assessed by cardiac computed tomography compared to the new anticoagulant therapy with rivaroxaban
Detailed Description:
A multi center prospective controlled open randomized interventional clinical trial blinded concerning outcome measurements with a two- arm parallel group design will be performed to investigate the association of rivaroxaban compared to coumadinphenprocoumon treatment for OAT in patients with atrial fibrillation and or pulmonary embolism regarding the development and progression of coronary artery calcification CAC and aortic valve calcification AVC as assessed by multi-slice spiral computed tomography scanning MSCT within one year follow-up
In total 190 patients 95 patients per treatment arm with atrial fibrillation and or pulmonary embolism with the indication for oral anticoagulation therapy will be enrolled
After screening first cardiac CT scan will be performed in order to validate if calcium score is 50 which is an inclusion criteria If the patient matches all other inclusionexclusion criteria the remaining imaging procedures Echocardiography Intima Media Thickness of carotid artery IMT and Flow Mediated Vasodilatation FMD Electrocardiography ECG and blood pressure are executed Pregnancy strip test will be executed and also serum chemistry hematology coagulation and batch analysis will be performed
Patients will then be randomized to one of the two arms Rivaroxaban or Marcumar and will undergo the same examinations and measurements as described above at 1 week 1 6 9 and 12 month Follow- Up FU In case of a positive result in respect to the primary endpoint a FU after 2 years will be performed
Primary outcome measures will be assessed after all active patients will have completed 12-months study visit interim analysis
In total 190 patients 95 patients per treatment arm with atrial fibrillation and or pulmonary embolism with the indication for oral anticoagulation therapy will be enrolled
After screening first cardiac CT scan will be performed in order to validate if calcium score is 50 which is an inclusion criteria If the patient matches all other inclusionexclusion criteria the remaining imaging procedures Echocardiography Intima Media Thickness of carotid artery IMT and Flow Mediated Vasodilatation FMD Electrocardiography ECG and blood pressure are executed Pregnancy strip test will be executed and also serum chemistry hematology coagulation and batch analysis will be performed
Patients will then be randomized to one of the two arms Rivaroxaban or Marcumar and will undergo the same examinations and measurements as described above at 1 week 1 6 9 and 12 month Follow- Up FU In case of a positive result in respect to the primary endpoint a FU after 2 years will be performed
Primary outcome measures will be assessed after all active patients will have completed 12-months study visit interim analysis
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