Persistent Atrial FibrillationPhase 4CREATIVE-AFNCT00613496
Irbesartan and Adhesion Molecules in AF
A Phase 4 study testing irbesartan in people with Persistent Atrial Fibrillation, run by University of Magdeburg at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- irbesartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Magdeburg; Div. of Cardiology
Magdeburg, 39120
Veronika Raetzel, 0049 391 6701, veronika.raetzel@medizin.uni-magdeburg.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- irbesartan, placebo
- Keywords
- Atrial Fibrillation, irbesartan, AT-II-antagonist, Adhesion Molecules, oxidative stress markers, hsCRP, ICAM, VCAM, MCP-1, vWF, TGFβ1, TNF-α, Interleukin-6, 8isoProstaglandinF2α
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irbesartanDrug
Also called Avapro, Aprovel, Carvea
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.
placeboDrug
Placebo-tablet, 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Placebo treatment in each patient during the study (9 weeks) using an intraindividual cross-over design Receives: Drug: placebo |
| 1 | Active comparator | Irbesartan treatment in each patient during the study (9 weeks) using an intraindividual cross-over design Receives: Drug: irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 22 weeks
Secondary outcomes (3)
Number of cerebrovascular events
Measured: 22 weeks
Number of intermediate medical visits for cardiovascular reasons without hospitalization
Measured: 22 weeks
Number of hospitalization for cardiovascular reasons and GFR
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startMay 2009
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Andreas Goette, MD, Principal investigator, University Hospital Magdeburg; Div of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613496
- Sponsor's protocol ID
- AG-1-2007
- Other IDs
- EUDRACTN: 2007-003262-17
- Acronym
- CREATIVE-AF
- Status last verified
- May 2009
- First submitted
- 31 Jan 2008
- Last updated
- 29 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Irbesartan on Oxidative Stress and C-Reactive Protein Levels in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00613496
- Acronym / sponsor ID
- CREATIVE-AF / AG-1-2007
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Atrial Fibrillation, irbesartan, AT-II-antagonist, Adhesion Molecules, oxidative stress markers, hsCRP, ICAM, VCAM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- May 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: placeboPlacebo treatment in each patient during the study (9 weeks) using an intraindividual cross-over design |
| 1 | Active comparator | Drug: irbesartanIrbesartan treatment in each patient during the study (9 weeks) using an intraindividual cross-over design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with persistent/permanent AF (>2 months)
- CHADS2 Score ≥2
- Age ≥18
- Patient informed orally and in writing
- Written informed consent of the patient
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| irbesartanAlso: Avapro, Aprovel, CarveaIrbesartan-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. | Drug | 1 |
| placeboPlacebo-tablet, 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8. | Drug | 2 |
Primary outcome
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
3 secondary outcomes
Number of cerebrovascular events
Time frame: 22 weeks
Number of intermediate medical visits for cardiovascular reasons without hospitalization
Time frame: 22 weeks
Number of hospitalization for cardiovascular reasons and GFR
Time frame: 22 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Goette, MD principal investigator
University Hospital Magdeburg; Div of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing irbesartan in people with Persistent Atrial Fibrillation, run by University of Magdeburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Goette, MD (00493916713225, andreas.goette@medizin.uni-magdeburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2009; AzTrials last refreshed its copy on 1 Nov 2026.