Irbesartan and Adhesion Molecules in AF (CREATIVE-AF)

May 28, 2009 updated by: University of Magdeburg

Impact of Irbesartan on Oxidative Stress and C-Reactive Protein Levels in Patients With Persistent Atrial Fibrillation

Experimental data suggest that angiotensin II-antagonists reduce the atrial expression of prothrombotic adhesion molecules and oxidative stress parameters. The present study is designed to investigate the effects on angiotensin II-antagonist irbesartan to reduce the amounts of circulating oxidative stress markers and adhesion molecules in patients with persistent atrial fibrillation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary Objective:

The aim of the study is to assess that blocking the angiotensin II type 1 receptor reduces systemic levels of oxidative stress markers and adhesion molecules by more than 25% compared to placebo in patients with persistent/permanent atrial fibrillation.

Primary Target Parameter:

The primary target parameter is defined as reduction of systemic levels of oxidative stress markers and adhesion molecules (hsCRP, ICAM, VCAM, MCP-1, vWF, TGFβ1, TNF-α, Interleukin-6, 8isoProstaglandinF2α)

Secondary Target Parameter:

The secondary Target Parameters are defined as number of cerebrovascular events, number of intermediate medical visits for cardiovascular reasons without hospitalisation, number of hospitalisations for cardiovascular reasons and GFR.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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:

  • Patients with persistent/permanent AF (>2 months)
  • CHADS2 Score ≥2
  • Age ≥18
  • Patient informed orally and in writing
  • Written informed consent of the patient
  • Patients who are anticipated to show sufficient compliance in following the study protocol
  • Patients must agree to undergo the 148 days clinical follow-up
  • Patients who are mentally and linguistically able to understand the aim of the study and the associated risks and benefits of the treatment. The patients, by providing informed consent, agree to this treatment as stated in the patient informed consent document.

Exclusion Criteria:

  • Strong clinical evidence that prevents the temporary pause of therapy with AT II antagonists
  • Symptomatic bradycardia
  • Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardia algorithm in use
  • Cardiac surgery or cardiac catheter ablation within the last 3 months prior to randomisation
  • Typical angina pectoris symptoms at rest or during exercise
  • Known coronary artery disease with indication for intervention
  • Symptomatic peripheral vascular disease
  • Left ventricular ejection fraction <35%
  • Myocardial infarction within 6 months prior to randomisation
  • Diastolic blood pressure >110mmHg at rest
  • Symptomatic arterial hypotension
  • Known renal artery stenosis
  • Serum creatinin >1.8mval/l
  • Chronic inflammatory disease
  • Acute inflammatory disease (CRP >20mg/L)
  • Relevant hepatic or pulmonary disorders
  • Hyperthyreosis 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 prior to randomisation
  • Drug addiction or chronic alcohol abuse
  • Cancer or other disease, which inevitably leads to death
  • 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: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Placebo treatment in each patient during the study (9 weeks) using an intraindividual cross-over design
Drug: placebo
Placebo-tablet, 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8.
ACTIVE_COMPARATOR: 1
Irbesartan treatment in each patient during the study (9 weeks) using an intraindividual cross-over design
Drug: irbesartan
Irbesartan-tablet (150 mg) 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8 if no contraindication for up titration (investigator will decide on the basis of creatinin, urea and potassium after taking a blood sample) for 9 weeks.
Other Names:
  • Aprovel
  • Avapro
  • Carvea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary target parameter is defined as reduction of systemic levels of oxidative stress markers and adhesion molecules (hsCRP, ICAM, VCAM, MCP-1, vWF, TGFβ1, TNF-α, Interleukin-6, 8isoProstaglandinF2α)
Time Frame: 22 weeks
22 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of cerebrovascular events
Time Frame: 22 weeks
22 weeks
Number of intermediate medical visits for cardiovascular reasons without hospitalization
Time Frame: 22 weeks
22 weeks
Number of hospitalization for cardiovascular reasons and GFR
Time Frame: 22 weeks
22 weeks

Collaborators and Investigators

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

Sponsor

University of Magdeburg

Collaborators

Sanofi

Investigators

  • Principal Investigator: Andreas Goette, MD, University Hospital Magdeburg; Div of Cardiology

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

May 1, 2009

Primary Completion (ANTICIPATED)

May 1, 2010

Study Completion (ANTICIPATED)

May 1, 2010

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (ESTIMATE)

February 13, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 29, 2009

Last Update Submitted That Met QC Criteria

May 28, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG-1-2007
  • EUDRACTN: 2007-003262-17

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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