Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial

ISRCTN	ISRCTN88528808
DOI	https://doi.org/10.1186/ISRCTN88528808
Protocol serial number	AF NET B10
Sponsor	German Atrial Fibrillation Network
Funder	German AF Network, Grant No 01GI0204 (Germany)

Submission date: 01/09/2005
Registration date: 04/10/2005
Last edited: 30/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andreas Goette
Scientific

University Hospital Magdeburg
Div. of Cardiology
Leipziger Str. 44
Magdeburg
39120
Germany

Phone	+49 (0)391 6713225
Email	andreas.goette@medizin.uni-magdeburg.de

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ANTIPAF
Study objectives	Blocking the angiotensin II type 1 receptor 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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Paroxysmal Atrial Fibrillation
Intervention	Examination of the study hypothesis in a prospective, randomized, placebo-controlled, double-blind group comparison in patients with documented paroxysmal atrial fibrillation. 40 mg/day Olmesartanmedoxomil versus Placebo.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Angiotensin II-Antagonist
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	1. Time to first occurrence of a documented relapse of atrial fibrillation 2. Time to first occurrence of a symptomatic documented episode of AF 3. Time to persistent atrial fibrillation 4. Time to prescription of the recovery-medication 5. Number of hospitalizations for cardiovascular reasons (-> Endpoint review) 6. Number of intermediate medical visits for cardiovascular reasons (-> Endpoint review) without hospitalization 7. Number of cerebrovascular events 8. Quality of life
Completion date	30/11/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	422
Key inclusion criteria	1. Documented paroxysmal atrial fibrillation: electrocardiogram (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 2. Age ≥18 3. Patient informed orally and in writing 4. Written informed consent of the patient
Key exclusion criteria	1. Strong clinical evidence for therapy with AT II/ACE inhibitors within the last month 2. Therapy with antiarrhythmic agents of class I or class III within the last month, therapy with amiodaron within the last 3 months 3. DC cardioversion within the last 3 months 4. Symptomatic bradycardia 5. Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use 6. Cardiac surgery or cardiac catheter ablation within the last 3 months 7. Typical angina pectoris symptoms at rest or during exercise 8. Known coronary artery disease with indication for intervention 9. Valvular disease >II degree 10. Left ventricular ejection fraction <40% 11. Diastolic blood pressure >110 mmHg at rest 12. Symptomatic arterial hypotension 13. Known renal artery stenosis 14. Serum creatinine >1.8 mval/l
Date of first enrolment	27/01/2005
Date of final enrolment	30/11/2007

Locations

Countries of recruitment

Germany

Study participating centre

University Hospital Magdeburg

Magdeburg
39120
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2007		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes