Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation
Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial (ANTIPAF Trial)
2 other identifiers
interventional
422
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2005
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2004
CompletedFirst Posted
Study publicly available on registry
December 6, 2004
CompletedStudy Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedSeptember 11, 2012
September 1, 2012
4.3 years
December 3, 2004
September 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of days with documented episodes of paroxysmal atrial fibrillation (number of days with paroxysmal atrial fibrillation/number of days with at least one readable Tele-ECG recording)
12 months follow-up
Secondary Outcomes (8)
Time to first occurrence of a documented relapse of atrial fibrillation
12 months follow up
Time to first occurrence of a symptomatic documented episode of AF
12 months follow up
Time to persistent atrial fibrillation
12 months follow up
Time to prescription of the recovery-medication
12 months follow up
Number of hospitalizations for cardiovascular reasons (-> Endpoint review)
12 months follow up
- +3 more secondary outcomes
Study Arms (2)
Olmesartan
EXPERIMENTALOlmesartan tablet, 1 in the morning
Placebo
PLACEBO COMPARATORPlacebo tablets, 1 in the morning
Interventions
Eligibility Criteria
You may qualify if:
- Documented paroxysmal atrial fibrillation: ECG documentation of atrial fibrillation at least in one ECG recorded during the last 2 months prior to randomization plus additional ECG recording of sinus rhythm at least 12 hours after the above mentioned ECG documentation.
- Age ≥ 18
- Patient informed orally and in writing
- Written informed consent of the patient
You may not qualify if:
- Strong clinical evidence for therapy with AT II/ACE inhibitors
- AT II/ACE inhibitor therapy within the last month
- Therapy with antiarrhythmic agents of class I or class III within the last month, therapy with amiodarone within the last 3 months
- Direct current (DC) cardioversion within the last 3 months
- Symptomatic bradycardia
- Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use
- Cardiac surgery or cardiac catheter ablation within the last 3 months
- Typical angina pectoris symptoms at rest or during exercise
- Known coronary artery disease with indication for intervention
- Valvular disease \> II degree
- Left ventricular ejection fraction \< 40%
- Diastolic blood pressure \> 110mm Hg at rest
- Symptomatic arterial hypotension
- Known renal artery stenosis
- Serum creatinine \> 1.8 mval/l
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atrial Fibrillation Networklead
- Daiichi Sankyocollaborator
Related Publications (3)
von Eisenhart Rothe AF, Goette A, Kirchhof P, Breithardt G, Limbourg T, Calvert M, Baumert J, Ladwig KH. Depression in paroxysmal and persistent atrial fibrillation patients: a cross-sectional comparison of patients enroled in two large clinical trials. Europace. 2014 Jun;16(6):812-9. doi: 10.1093/europace/eut361. Epub 2013 Dec 18.
PMID: 24351885DERIVEDvon Eisenhart Rothe A, Bielitzer M, Meinertz T, Limbourg T, Ladwig KH, Goette A. Predictors of discordance between physicians' and patients' appraisals of health-related quality of life in atrial fibrillation patients: findings from the Angiotensin II Antagonist in Paroxysmal Atrial Fibrillation Trial. Am Heart J. 2013 Sep;166(3):589-96. doi: 10.1016/j.ahj.2013.05.020. Epub 2013 Jul 10.
PMID: 24016511DERIVEDGoette A, Schon N, Kirchhof P, Breithardt G, Fetsch T, Hausler KG, Klein HU, Steinbeck G, Wegscheider K, Meinertz T. Angiotensin II-antagonist in paroxysmal atrial fibrillation (ANTIPAF) trial. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):43-51. doi: 10.1161/CIRCEP.111.965178. Epub 2011 Dec 7.
PMID: 22157519DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Meinertz, MD
University Hospital Hamburg
- PRINCIPAL INVESTIGATOR
Andreas Goette, MD
University Hospital Magdeburg
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2004
First Posted
December 6, 2004
Study Start
January 1, 2005
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
September 11, 2012
Record last verified: 2012-09