Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-27 @ 9:17 AM
Study NCT ID:
NCT01710267
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2012-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2)
Sponsor:
Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhD
Organization:
Study Overview
Official Title:
Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2)
Status:
COMPLETED
Status Verified Date:
2015-03
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:
RivaMoS2
Brief Summary:
Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied for prophylaxis of venous thromboembolism after major orthopedic surgery. Additionally, RXA is approved by Swissmedic to be used at a therapeutic dose for primary therapy of VTE and for prophylaxis of cerebrovascular events in non-valvular atrial fibrillation.
This is an explorative laboratory study to evaluate the intra-individual variability of RXA conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.
This is an explorative laboratory study to evaluate the intra-individual variability of RXA conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.
Detailed Description:
Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied for prophylaxis of venous thromboembolism (VTE) after major orthopedic surgery of the lower limbs such as hip and knee replacement surgery. Additionally, RXA is approved by Swissmedic to be used at a therapeutic dose for primary therapy of VTE and for prophylaxis of cerebrovascular events in non-valvular atrial fibrillation.
Monitoring of RXA concentration (conc.) is generally not required because of its stable pharmacokinetic and pharmacodynamic profile, even in patients with renal insufficiency. However, there are several clinical situations, in which it may be desirable to measure the RXA plasma conc. The range of RXA conc. is wide among individuals with typical peak levels of median 244 µg/L (IQR 175-360) and trough levels of median 32 µg/L (IQR 19-60) with once daily doses of 20 mg RXA.
This is an explorative laboratory study to evaluate the intra-individual variability of RXA conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.
Monitoring of RXA concentration (conc.) is generally not required because of its stable pharmacokinetic and pharmacodynamic profile, even in patients with renal insufficiency. However, there are several clinical situations, in which it may be desirable to measure the RXA plasma conc. The range of RXA conc. is wide among individuals with typical peak levels of median 244 µg/L (IQR 175-360) and trough levels of median 32 µg/L (IQR 19-60) with once daily doses of 20 mg RXA.
This is an explorative laboratory study to evaluate the intra-individual variability of RXA conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.
Study Oversight
Has Oversight DMC:
True
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?: