Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098137
Status:
COMPLETED
Last Update Posted:
2012-09-11
First Post:
2004-12-03
Brief Title:
Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation
Sponsor:
Atrial Fibrillation Network
Organization:
Atrial Fibrillation Network
Study Overview
Official Title:
Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial ANTIPAF Trial
Status:
COMPLETED
Status Verified Date:
2012-09
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:
Hypothesis
Blocking the angiotensin AT II type 1 receptor Olmesartan reduces the incidence of episodes of atrial fibrillation in patients with paroxysmal atrial fibrillation during 12 months by more than 25 compared to standard medication without angiotensin II type 1 receptor
A total of 422 subjects will be included in the two study groups The treatment arm will receive 40mg Olmesartan per day the remaining patients will receive placebo Follow-up is 12 months Daily Tele-ECG recordings will determine the cardiac rhythm and asymptomatic episodes of atrial fibrillation AF every day Concomitant therapy with AV-nodal blocking drugs are allowed during the study In case of severe AF-induced symptoms an antiarrhythmic recovery medication amiodarone is allowed during follow-up
Blocking the angiotensin AT II type 1 receptor Olmesartan reduces the incidence of episodes of atrial fibrillation in patients with paroxysmal atrial fibrillation during 12 months by more than 25 compared to standard medication without angiotensin II type 1 receptor
A total of 422 subjects will be included in the two study groups The treatment arm will receive 40mg Olmesartan per day the remaining patients will receive placebo Follow-up is 12 months Daily Tele-ECG recordings will determine the cardiac rhythm and asymptomatic episodes of atrial fibrillation AF every day Concomitant therapy with AV-nodal blocking drugs are allowed during the study In case of severe AF-induced symptoms an antiarrhythmic recovery medication amiodarone is allowed during follow-up
Detailed Description:
Double-blind central randomization two treatment groups stratified by beta-blocker use 211 patients in each treatment arm
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 |
|---|---|---|---|
| Grant No 01GI0204 | OTHER_GRANT | BMBF | None |