Condition category
Circulatory System
Date applied
01/09/2005
Date assigned
04/10/2005
Last edited
30/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.kompetenznetz-vorhofflimmern.de

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 measures

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

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

http://www.kompetenznetz-vorhofflimmern.de

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17803345

Publication citations

  1. 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.

Additional files

Editorial Notes