Ignite Creation Date:
2024-05-05 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00613496
Status:
UNKNOWN
Last Update Posted:
2009-05-29
First Post:
2008-01-31
Brief Title:
Irbesartan and Adhesion Molecules in AF
Sponsor:
University of Magdeburg
Organization:
University of Magdeburg
Study Overview
Official Title:
Impact of Irbesartan on Oxidative Stress and C-Reactive Protein Levels in Patients With Persistent Atrial Fibrillation
Status:
UNKNOWN
Status Verified Date:
2009-05
Last Known Status:
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:
CREATIVE-AF
Brief Summary:
Experimental data suggest that angiotensin II-antagonists reduce the atrial expression of prothrombotic adhesion molecules and oxidative stress parameters The present study is designed to investigate the effects on angiotensin II-antagonist irbesartan to reduce the amounts of circulating oxidative stress markers and adhesion molecules in patients with persistent atrial fibrillation
Detailed Description:
Primary Objective
The aim of the study is to assess that blocking the angiotensin II type 1 receptor reduces systemic levels of oxidative stress markers and adhesion molecules by more than 25 compared to placebo in patients with persistentpermanent atrial fibrillation
Primary Target Parameter
The primary target parameter is defined as reduction of systemic levels of oxidative stress markers and adhesion molecules hsCRP ICAM VCAM MCP-1 vWF TGFβ1 TNF-α Interleukin-6 8isoProstaglandinF2α
Secondary Target Parameter
The secondary Target Parameters are defined as number of cerebrovascular events number of intermediate medical visits for cardiovascular reasons without hospitalisation number of hospitalisations for cardiovascular reasons and GFR
The aim of the study is to assess that blocking the angiotensin II type 1 receptor reduces systemic levels of oxidative stress markers and adhesion molecules by more than 25 compared to placebo in patients with persistentpermanent atrial fibrillation
Primary Target Parameter
The primary target parameter is defined as reduction of systemic levels of oxidative stress markers and adhesion molecules hsCRP ICAM VCAM MCP-1 vWF TGFβ1 TNF-α Interleukin-6 8isoProstaglandinF2α
Secondary Target Parameter
The secondary Target Parameters are defined as number of cerebrovascular events number of intermediate medical visits for cardiovascular reasons without hospitalisation number of hospitalisations for cardiovascular reasons and GFR
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACTN 2007-003262-17 | None | None | None |