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11 February 2012
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| [ Print-friendly version ] |
| Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial |
| ISRCTN | ISRCTN88528808 |
| ClinicalTrials.gov identifier | |
| Public title | Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial |
| Scientific title | |
| Acronym | ANTIPAF |
| Serial number at source | AF NET B10 |
| 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. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Paroxysmal Atrial Fibrillation |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 27/01/2005 |
| Anticipated end date | 30/11/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 422 |
| Interventions |
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. |
| 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) |
| 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 |
| Sources of funding | German AF Network, Grant No 01GI0204 (Germany) |
| Trial website | http://www.kompetenznetz-vorhofflimmern.de |
| Publications | 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17803345 |
| Contact name | Dr Andreas Goette |
| Address |
University Hospital Magdeburg
Div. of Cardiology Leipziger Str. 44 |
| City/town | Magdeburg |
| Zip/Postcode | 39120 |
| Country | Germany |
| Tel | +49 (0)391 6713225 |
| Fax | +49 (0)391 6713202 |
| andreas.goette@medizin.uni-magdeburg.de | |
| Sponsor | German Atrial Fibrillation Network |
| Address | Domagkstr. 11 |
| City/town | Münster |
| Zip/Postcode | 48149 |
| Country | Germany |
| Tel | +49 (0)251834 53 41 |
| Fax | +49 (0)251834 53 43 |
| Thomas.Weiss@ukmuenster.de | |
| Sponsor website: | http://www.kompetenznetz-vorhofflimmern.de |
| Date applied | 01/09/2005 |
| Last edited | 30/10/2008 |
| Date ISRCTN assigned | 04/10/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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