Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial
| ISRCTN | ISRCTN88528808 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88528808 |
| Secondary identifying numbers | AF NET B10 |
- 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
Scientific
University Hospital Magdeburg
Div. of Cardiology
Leipziger Str. 44
Magdeburg
39120
Germany
| Phone | +49 (0)391 6713225 |
|---|---|
| andreas.goette@medizin.uni-magdeburg.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 27/01/2005 |
| Completion date | 30/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
39120
Germany
Sponsor information
German Atrial Fibrillation Network
Research organisation
Research organisation
Domagkstr. 11
Münster
48149
Germany
| Phone | +49 (0)251834 53 41 |
|---|---|
| Thomas.Weiss@ukmuenster.de | |
| Website | http://www.kompetenznetz-vorhofflimmern.de |
"ROR" |
https://ror.org/01spm3d88 |
Funders
Funder type
Research organisation
German AF Network, Grant No 01GI0204 (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
