Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation

Sponsor

Atrial Fibrillation Network (Other)

Overall Status

Completed

CT.gov ID

NCT00098137

Collaborator

Daiichi Sankyo, Inc. (Industry)

422

Enrollment

Arms

51.9

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Heart Disease Arrhythmia Atrial Fibrillation	Drug: Olmesartan	Phase 3

Detailed Description

Double-blind, central randomization, two treatment groups, stratified by beta-blocker use. 211 patients in each treatment arm.

Study Design

Study Type:

Interventional

Actual Enrollment :

422 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial (ANTIPAF Trial)

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olmesartan Olmesartan tablet, 1 in the morning	Drug: Olmesartan
Placebo Comparator: Placebo Placebo tablets, 1 in the morning	Drug: Olmesartan

Arm

Intervention/Treatment

Experimental: Olmesartan

Olmesartan tablet, 1 in the morning

Drug: Olmesartan

Placebo Comparator: Placebo

Placebo tablets, 1 in the morning

Drug: Olmesartan

Outcome Measures

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) [12 months follow-up]

Secondary Outcome Measures

Time to first occurrence of a documented relapse of atrial fibrillation [12 months follow up]
Time to first occurrence of a symptomatic documented episode of AF [12 months follow up]
Time to persistent atrial fibrillation [12 months follow up]
Time to prescription of the recovery-medication [12 months follow up]
Number of hospitalizations for cardiovascular reasons (-> Endpoint review) [12 months follow up]
Number of intermediate medical visits for cardiovascular reasons (-> Endpoint review) without hospitalization [12 months follow up]
Number of cerebrovascular events [12 months follow up]
Quality of life [12 months follow up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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