Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Angiotensin II
Olmesartan
Olmesartan medoxomil
Angiotensin Receptor Antagonists
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014