Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation
This study has been completed.
Sponsor:
German Atrial Fibrillation Network
Collaborator:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
German Atrial Fibrillation Network
ClinicalTrials.gov Identifier:
NCT00098137
First received: December 3, 2004
Last updated: September 10, 2012
Last verified: September 2012
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Purpose
Hypothesis:
Blocking the angiotensin (AT) II type 1 receptor (Olmesartan) 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.
A total of 422 subjects will be included in the two study groups. The treatment arm will receive 40mg Olmesartan per day, the remaining patients will receive placebo. Follow-up is 12 months. Daily Tele-ECG recordings will determine the cardiac rhythm and asymptomatic episodes of atrial fibrillation (AF) every day. Concomitant therapy with AV-nodal blocking drugs are allowed during the study. In case of severe AF-induced symptoms, an antiarrhythmic "recovery medication" (amiodarone) is allowed during follow-up.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Disease Arrhythmia Atrial Fibrillation |
Drug: Olmesartan |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial (ANTIPAF Trial) |
Resource links provided by NLM:
Further study details as provided by German Atrial Fibrillation Network:
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) [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to first occurrence of a documented relapse of atrial fibrillation [ Time Frame: 12 months follow up ] [ Designated as safety issue: No ]
- Time to first occurrence of a symptomatic documented episode of AF [ Time Frame: 12 months follow up ] [ Designated as safety issue: No ]
- Time to persistent atrial fibrillation [ Time Frame: 12 months follow up ] [ Designated as safety issue: No ]
- Time to prescription of the recovery-medication [ Time Frame: 12 months follow up ] [ Designated as safety issue: No ]
- Number of hospitalizations for cardiovascular reasons (-> Endpoint review) [ Time Frame: 12 months follow up ] [ Designated as safety issue: Yes ]
- Number of intermediate medical visits for cardiovascular reasons (-> Endpoint review) without hospitalization [ Time Frame: 12 months follow up ] [ Designated as safety issue: Yes ]
- Number of cerebrovascular events [ Time Frame: 12 months follow up ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: 12 months follow up ] [ Designated as safety issue: No ]
| Enrollment: | 422 |
| Study Start Date: | January 2005 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Olmesartan
Olmesartan tablet, 1 in the morning
|
Drug: Olmesartan |
|
Placebo Comparator: Placebo
Placebo tablets, 1 in the morning
|
Drug: Olmesartan |
Detailed Description:
Double-blind, central randomization, two treatment groups, stratified by beta-blocker use. 211 patients in each treatment arm.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documented paroxysmal atrial fibrillation: 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.
- Age ≥ 18
- Patient informed orally and in writing
- Written informed consent of the patient
Exclusion Criteria:
- Strong clinical evidence for therapy with AT II/ACE inhibitors
- AT II/ACE inhibitor therapy within the last month
- Therapy with antiarrhythmic agents of class I or class III within the last month, therapy with amiodarone within the last 3 months
- Direct current (DC) cardioversion within the last 3 months
- Symptomatic bradycardia
- Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use
- Cardiac surgery or cardiac catheter ablation within the last 3 months
- Typical angina pectoris symptoms at rest or during exercise
- Known coronary artery disease with indication for intervention
- Valvular disease > II degree
- Left ventricular ejection fraction < 40%
- Diastolic blood pressure > 110mm Hg at rest
- Symptomatic arterial hypotension
- Known renal artery stenosis
- Serum creatinine > 1.8 mval/l
- Relevant hepatic or pulmonary disorders
- Hyperthyroidism manifested clinically and in laboratory
- Known drug intolerance for AT II inhibitors
- Females who are pregnant or breast feeding
- Females of childbearing potential who are not using a scientifically accepted method of contraception
- Participation in a clinical trial within the last 30 days
- Drug addiction or chronic alcohol abuse
- Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical study
- Evidence of an uncooperative attitude
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098137
Sponsors and Collaborators
German Atrial Fibrillation Network
Daiichi Sankyo Inc.
Investigators
| Principal Investigator: | Thomas Meinertz, MD | University Hospital Hamburg |
| Principal Investigator: | Andreas Goette, MD | University Hospital Magdeburg |
More Information
Additional Information:
No publications provided by German Atrial Fibrillation Network
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | German Atrial Fibrillation Network |
| ClinicalTrials.gov Identifier: | NCT00098137 History of Changes |
| Other Study ID Numbers: | AFNET-B10, Grant No 01GI0204 |
| Study First Received: | December 3, 2004 |
| Last Updated: | September 10, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by German Atrial Fibrillation Network:
|
atrial fibrillation angiotensin II angiotensin receptor antagonist drug controlled clinical trial |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Atrial Fibrillation Heart Diseases Cardiovascular Diseases Pathologic Processes Angiotensin II Olmesartan medoxomil Olmesartan |
Angiotensin Receptor Antagonists Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Antihypertensive Agents |
ClinicalTrials.gov processed this record on May 19, 2013