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Rationale for and design of the CREATIVE-AF trial: randomized, double-blind, placebo-controlled, crossover study of the effect of irbesartan on oxidative stress and adhesion molecules in patients with persistent atrial fibrillation
- Source :
- Clinical drug investigation. 28(9)
- Publication Year :
- 2008
-
Abstract
- Background and objective: Atrial fibrillation (AF) is the most common cardiac arrhythmia. Recent studies suggest there is an angiotensin II-dependent increase in adhesion molecules and oxidative stress parameters during AF. These alterations appear to contribute to inflammatory and prothrombotic changes in the atrial endocardium (‘endocardial remodelling’), suggesting that patients with increased levels of these factors might be at risk of thromboembolic events. The purpose of the CREATIVE-AF (Impact of Irbesartan on Oxidative Stress and C-Reactive Protein Levels in Patients with Persistent Atrial Fibrillation) trial is to prove the principle concept that blockade of angiotensin II type 1 receptors by irbesartan reduces levels of circulating adhesion molecules and oxidative stress parameters in patients with persistent AF by 25% compared with placebo. Methods: This is a prospective, randomized, double-blind, placebo-controlled, crossover study in patients with persistent/permanent AF. A total of 60 patients are planned to be included in the study. Patients will receive placebo and irbesartan therapy for 9 weeks each. Levels of adhesion molecules (intercellular adhesion molecule-1, vascular cell adhesion molecule-1), inflammatory markers (high sensitivity C-reactive protein, monocyte chemoattractant protein-1, von Willebrand factor, tumour growth factor-β1, tumour necrosis factor-α, interleukin-6) and oxidative stress parameters (8-iso-prostaglandin F2α) will be determined after each treatment phase and compared with baseline levels. Conclusion: Angiotensin II type 1 receptor antagonists may help reduce levels of circulating adhesion molecules and oxidative stress parameters in patients with persistent AF. This article summarizes the rationale and design of the CREATIVE-AF trial, which has been designed to test this hypothesis. ClinicalTrials.gov identifier: NCT00613496.
- Subjects :
- Adult
Male
medicine.medical_specialty
Adolescent
Endpoint Determination
Tetrazoles
medicine.disease_cause
Young Adult
Irbesartan
Von Willebrand factor
Double-Blind Method
Internal medicine
Atrial Fibrillation
medicine
Humans
Pharmacology (medical)
Cell adhesion
Aged
Cross-Over Studies
biology
Cell adhesion molecule
business.industry
Patient Selection
Biphenyl Compounds
Atrial fibrillation
General Medicine
Middle Aged
medicine.disease
Angiotensin II
Crossover study
Oxidative Stress
Data Interpretation, Statistical
Sample Size
Cardiology
biology.protein
Female
business
Angiotensin II Type 1 Receptor Blockers
Cell Adhesion Molecules
Oxidative stress
Biomarkers
medicine.drug
Subjects
Details
- ISSN :
- 11732563
- Volume :
- 28
- Issue :
- 9
- Database :
- OpenAIRE
- Journal :
- Clinical drug investigation
- Accession number :
- edsair.doi.dedup.....640374a317fc3cf748810380dce94a66