Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation

September 10, 2012 updated by: Atrial Fibrillation Network

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

422

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Olmesartan
Olmesartan tablet, 1 in the morning
Drug: Olmesartan
PLACEBO_COMPARATOR: Placebo
Placebo tablets, 1 in the morning
Drug: Olmesartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atrial Fibrillation Network

Collaborators

Daiichi Sankyo, Inc.

Investigators

  • Principal Investigator: Thomas Meinertz, MD, University Hospital Hamburg
  • Principal Investigator: Andreas Goette, MD, University Hospital Magdeburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

December 3, 2004

First Submitted That Met QC Criteria

December 3, 2004

First Posted (ESTIMATE)

December 6, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

September 11, 2012

Last Update Submitted That Met QC Criteria

September 10, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFNET-B10
  • Grant No 01GI0204 (OTHER_GRANT: BMBF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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