Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Andreas Goette
ORCID ID
Contact details
University Hospital Magdeburg
Div. of Cardiology
Leipziger Str. 44
Magdeburg
39120
Germany
+49 (0)391 6713225
andreas.goette@medizin.uni-magdeburg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AF NET B10
Study information
Scientific title
Acronym
ANTIPAF
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Angiotensin II-Antagonist
Primary outcome measure
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)
Secondary outcome measures
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
Overall trial start date
27/01/2005
Overall trial end date
30/11/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
422
Participant 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
Recruitment start date
27/01/2005
Recruitment end date
30/11/2007
Locations
Countries of recruitment
Germany
Trial participating centre
University Hospital Magdeburg
Magdeburg
39120
Germany
Sponsor information
Organisation
German Atrial Fibrillation Network
Sponsor details
Domagkstr. 11
Münster
48149
Germany
+49 (0)251834 53 41
Thomas.Weiss@ukmuenster.de
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
German AF Network, Grant No 01GI0204 (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17803345
Publication citations
-
Results
Goette A, Breithardt G, Fetsch T, Hanrath P, Klein HU, Lehmacher W, Steinbeck G, Meinertz T, Angiotensin II antagonist in paroxysmal atrial fibrillation (ANTIPAF) trial: rationale and study design., Clin Drug Investig, 2007, 27, 10, 697-705.