Trial record 6 of 1123 for:    atrial fibrillation

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
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 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 April 17, 2014