Atrial FibrillationPhase 3ATHENANCT00174785
A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation
A Phase 3 study testing dronedarone (SR33589) in people with Atrial Fibrillation and Atrial Flutter, run by Sanofi at 37 sites in 37 countries.
Trial summary
To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL). To assess that dronedarone is well tolerated in this population. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- dronedarone (SR33589)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,628 participants
- Where
- 37 sitesin 37 countries
- Study dates
- Jun 2005to Mar 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 1. Patients aged 75 years or older (70 years before protocol amendment 1), or patients aged at least 70 years (any age before protocol amendment 1) with one or more of the following risk factors at baseline:
- Hypertension (taking antihypertensive drugs of at least two different classes)
- Diabetes
- Prior cerebrovascular accident (stroke or transient ischemic attack) or systemic embolism
- Left atrium diameter greater than or equal to 50 mm by echocardiography
- Left ventricular ejection fraction less than 0.40 by 2D-echocardiography (two-dimensional echocardiography)
- 2. Availability of one electrocardiogram (ECG) within the last 6 months, showing that the patient was or is in AF/AFL
- 3. Availability of one ECG within the last 6 months, showing that the patient was or is in sinus rhythm
Who cannot join
- General criteria:
- 1. Refusal or inability to give informed consent to participate in the study
- 2. Any non cardiovascular illness or disorder that could preclude participation or severely limit survival including cancer with metastasis and organ transplantation requiring immune suppression
- 3. Pregnant women (pregnancy test must be negative) or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intra-uterine device (IUD)] or sterile can be randomized.
- 4. Breastfeeding women
- 5. Previous (2 preceding months) or current participation in another clinical trial with an investigational drug (under development) or with an investigational device
Show all 19Show fewer
- 6. Previous participation in this trial
- Criteria Related to a cardiac condition:
- 7. Patients in permanent atrial fibrillation
- 8. Patients in unstable hemodynamic condition such as acute pulmonary edema within 12 hours prior to start of study medication; cardiogenic shock; treatment with intra-venous pressor agents; patients on respirator; congestive heart failure of stage NYHA IV (New York Heart Association classification) within the last 4 weeks; uncorrected, hemodynamically significant primary obstructive valvular disease; hemodynamically significant obstructive cardiomyopathy; a cardiac operation or revascularization procedure within 4 weeks preceding randomization
- 9. Planned major non-cardiac or cardiac surgery or procedures including surgery for valvular heart disease, coronary artery bypass graft (CABG) , percutaneous coronary intervention (PCI) , or on urgent cardiac transplantation list
- 10. Acute myocarditis or constrictive pericarditis
- 11. Bradycardia < 50 bpm and/or PR-interval > 0.28 sec on the last 12-lead ECG
- 12. Significant sinus node disease (documented pause of 3 seconds or more) or 2nd or 3rd degree atrioventricular block (AV-block) unless treated with a pacemaker
- Criteria Related to Concomitant Medications:
- 13. Need of a concomitant medication that is prohibited in this trial, including the requirement for Vaughan Williams Class I and III anti-arrhythmic drugs, that would preclude the use of study drug during the planned study period
- Criteria Related to Laboratory Abnormalities:
- 14. Plasma potassium < 3.5 mmol/l (as anti-arrhythmic drugs can be arrhythmogenic in patients with hypokalemia, this must be corrected prior to randomization)
- 15. A calculated Glomerular Filtration Rate (GFR) at baseline <10 ml/min using the Cockroft Gault formula
Trial locations and contacts
37 sites in 37 countries.
37 sites in 37 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
Official title: A Placebo-controlled,Double-blind,Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/Atrial Flutter (AF/AFL)
To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL).
To assess that dronedarone is well tolerated in this population.
Read the detailed description
This is a prospective, multinational, double-blind, randomized, multi-center, placebo-controlled, parallel-group trial evaluating the effects of dronedarone versus placebo (ratio 1:1) over a minimum treatment duration of 12 months and a mean follow-up duration of 1.75 years (in AF/AFL patients). Patients can be included in the study while in atrial fibrillation/flutter or in sinus rhythm if conversion has occurred either spontaneously or following a procedure such as electrical cardioversion (or overdrive pacing) or administration of an antiarrhythmic drug.After randomization all patients will be followed until the common study end date; the last patient included in the study will be followed for 1 year. Visits will be at baseline, after 7 days, after 14 days, after one month, after three months and then every three months until end of the study. At each visit patients will be asked for the occurrence of hospitalizations or other events since the last visit. The study will be monitored by an independent Data Monitoring Committee (DMC) for safety, tolerability and efficacy.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- dronedarone (SR33589), placebo
- Keywords
- Mortality, Hospitalization
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dronedarone (SR33589)Drug
Also called Multaq®
oral administration (tablets)
placeboDrug
oral administration (tablets)
| Study group | Role | What they receive |
|---|---|---|
| Dronedarone 400mg bid | Experimental | Dronedarone 400mg tablets twice daily (bid) Receives: Drug: dronedarone (SR33589) |
| Placebo | Placebo comparator | matching placebo tablets Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Hospitalization for Cardiovascular Reason or Death From Any Cause
The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Measured: minimum follow-up duration: 1 year ; maximum: 2.5 years
Secondary outcomes (3)
Death From Any Cause
The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Measured: minimum follow-up duration: 1 year ; maximum: 2.5 years
First Hospitalization for Cardiovascular Reason
The considered event is the first hospitalization for cardiovascular reason, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Measured: minimum follow-up duration: 1 year ; maximum: 2.5 years
Cardiovascular Death
The considered event is cardiovascular death, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Measured: minimum follow-up duration: 1 year ; maximum: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- International Clinical Development, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174785
- Sponsor's protocol ID
- EFC5555
- Acronym
- ATHENA
- Status last verified
- Jan 2010
- First submitted
- 13 Sep 2005
- Last updated
- 12 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hohnloser SH, Connolly SJ, Crijns HJ, Page RL, Seiz W, Torp-Petersen C. Rationale and design of ATHENA: A placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter. J Cardiovasc Electrophysiol. 2008 Jan;19(1):69-73. doi: 10.1111/j.1540-8167.2007.01016.x. Epub 2007 Nov 21.
PubMed 18031520Hohnloser SH, Crijns HJ, van Eickels M, Gaudin C, Page RL, Torp-Pedersen C, Connolly SJ; ATHENA Investigators. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med. 2009 Feb 12;360(7):668-78. doi: 10.1056/NEJMoa0803778.
PubMed 19213680Vamos M, Vagvolgyi A, McKindley DS, Hohnloser SH. Efficacy and Safety of Dronedarone in Overweight and Obesity: Post Hoc Analysis of the ATHENA Trial. J Cardiovasc Electrophysiol. 2026 May;37(5):969-979. doi: 10.1111/jce.70322. Epub 2026 Mar 22.
PubMed 41865291Kirchhof P, Camm AJ, Crijns HJGM, Piccini JP, Torp-Pedersen C, McKindley DS, Wieloch M, Hohnloser SH. Dronedarone provides effective early rhythm control: post-hoc analysis of the ATHENA trial using EAST-AFNET 4 criteria. Europace. 2025 Mar 28;27(4):euaf080. doi: 10.1093/europace/euaf080.
PubMed 40295782Handelsman Y, Bunch TJ, Rodbard HW, Steinberg BA, Thind M, Bigot G, Konigsberg L, Wieloch M, Kowey PR. Impact of dronedarone on patients with atrial fibrillation and diabetes: A sub-analysis of the ATHENA and EURIDIS/ADONIS studies. J Diabetes Complications. 2022 Jul;36(7):108227. doi: 10.1016/j.jdiacomp.2022.108227. Epub 2022 Jun 8.
PubMed 35717354Vamos M, Oldgren J, Nam GB, Lip GYH, Calkins H, Zhu J, Ueng KC, Ludwigs U, Wieloch M, Stewart J, Hohnloser SH. Dronedarone vs. placebo in patients with atrial fibrillation or atrial flutter across a range of renal function: a post hoc analysis of the ATHENA trial. Eur Heart J Cardiovasc Pharmacother. 2022 Jun 8;8(4):363-371. doi: 10.1093/ehjcvp/pvab090.
PubMed 34958366Akerborg O, Nilsson J, Bascle S, Lindgren P, Reynolds M. Cost-effectiveness of dronedarone in atrial fibrillation: results for Canada, Italy, Sweden, and Switzerland. Clin Ther. 2012 Aug;34(8):1788-802. doi: 10.1016/j.clinthera.2012.06.007. Epub 2012 Jul 6.
PubMed 22770643Torp-Pedersen C, Crijns HJ, Gaudin C, Page RL, Connolly SJ, Hohnloser SH; ATHENA Investigators. Impact of dronedarone on hospitalization burden in patients with atrial fibrillation: results from the ATHENA study. Europace. 2011 Aug;13(8):1118-26. doi: 10.1093/europace/eur102. Epub 2011 May 15.
PubMed 21576129Page RL, Connolly SJ, Crijns HJ, van Eickels M, Gaudin C, Torp-Pedersen C, Hohnloser SH; ATHENA Investigators. Rhythm- and rate-controlling effects of dronedarone in patients with atrial fibrillation (from the ATHENA trial). Am J Cardiol. 2011 Apr 1;107(7):1019-22. doi: 10.1016/j.amjcard.2010.11.028. Epub 2011 Feb 4.
PubMed 21296333Hohnloser SH, Crijns HJ, van Eickels M, Gaudin C, Page RL, Torp-Pedersen C, Connolly SJ; ATHENA Investigators. Dronedarone in patients with congestive heart failure: insights from ATHENA. Eur Heart J. 2010 Jul;31(14):1717-21. doi: 10.1093/eurheartj/ehq113. Epub 2010 Apr 30.
PubMed 20436046
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled,Double-blind,Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/Atrial Flutter (AF/AFL)
- ClinicalTrials.gov ID
- NCT00174785
- Acronym / sponsor ID
- ATHENA / EFC5555
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- Mortality, Hospitalization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,628 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 23 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL).
To assess that dronedarone is well tolerated in this population.
Detailed description
This is a prospective, multinational, double-blind, randomized, multi-center, placebo-controlled, parallel-group trial evaluating the effects of dronedarone versus placebo (ratio 1:1) over a minimum treatment duration of 12 months and a mean follow-up duration of 1.75 years (in AF/AFL patients). Patients can be included in the study while in atrial fibrillation/flutter or in sinus rhythm if conversion has occurred either spontaneously or following a procedure such as electrical cardioversion (or overdrive pacing) or administration of an antiarrhythmic drug.After randomization all patients will be followed until the common study end date; the last patient included in the study will be followed for 1 year. Visits will be at baseline, after 7 days, after 14 days, after one month, after three months and then every three months until end of the study. At each visit patients will be asked for the occurrence of hospitalizations or other events since the last visit. The study will be monitored by an independent Data Monitoring Committee (DMC) for safety, tolerability and efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dronedarone 400mg bid | Experimental | Drug: dronedarone (SR33589)Dronedarone 400mg tablets twice daily (bid) |
| Placebo | Placebo comparator | Drug: placebomatching placebo tablets |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 1. Patients aged 75 years or older (70 years before protocol amendment 1), or patients aged at least 70 years (any age before protocol amendment 1) with one or more of the following risk factors at baseline:
- 2. Availability of one electrocardiogram (ECG) within the last 6 months, showing that the patient was or is in AF/AFL
- 3. Availability of one ECG within the last 6 months, showing that the patient was or is in sinus rhythm
Key exclusion criteria (19 listed)
- 1. Refusal or inability to give informed consent to participate in the study
- 2. Any non cardiovascular illness or disorder that could preclude participation or severely limit survival including cancer with metastasis and organ transplantation requiring immune suppression
- 3. Pregnant women (pregnancy test must be negative) or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intra-uterine device (IUD)] or sterile can be randomized.
- 4. Breastfeeding women
- 5. Previous (2 preceding months) or current participation in another clinical trial with an investigational drug (under development) or with an investigational device
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 |
|---|---|---|
| dronedarone (SR33589)Also: Multaq®oral administration (tablets) | Drug | Dronedarone 400mg bid |
| placebooral administration (tablets) | Drug | Placebo |
Primary outcome
First Hospitalization for Cardiovascular Reason or Death From Any Cause
Time frame: minimum follow-up duration: 1 year ; maximum: 2.5 years
The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
3 secondary outcomes
Death From Any Cause
Time frame: minimum follow-up duration: 1 year ; maximum: 2.5 years
First Hospitalization for Cardiovascular Reason
Time frame: minimum follow-up duration: 1 year ; maximum: 2.5 years
Cardiovascular Death
Time frame: minimum follow-up duration: 1 year ; maximum: 2.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18031520Hohnloser SH, Connolly SJ, Crijns HJ, Page RL, Seiz W, Torp-Petersen C. Rationale and design of ATHENA: A placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter. J Cardiovasc Electrophysiol. 2008 Jan;19(1):69-73. doi: 10.1111/j.1540-8167.2007.01016.x. Epub 2007 Nov 21.
- Results publication: PubMed 19213680Hohnloser SH, Crijns HJ, van Eickels M, Gaudin C, Page RL, Torp-Pedersen C, Connolly SJ; ATHENA Investigators. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med. 2009 Feb 12;360(7):668-78. doi: 10.1056/NEJMoa0803778.
- Derived from this study: PubMed 41865291Vamos M, Vagvolgyi A, McKindley DS, Hohnloser SH. Efficacy and Safety of Dronedarone in Overweight and Obesity: Post Hoc Analysis of the ATHENA Trial. J Cardiovasc Electrophysiol. 2026 May;37(5):969-979. doi: 10.1111/jce.70322. Epub 2026 Mar 22.
- Derived from this study: PubMed 40295782Kirchhof P, Camm AJ, Crijns HJGM, Piccini JP, Torp-Pedersen C, McKindley DS, Wieloch M, Hohnloser SH. Dronedarone provides effective early rhythm control: post-hoc analysis of the ATHENA trial using EAST-AFNET 4 criteria. Europace. 2025 Mar 28;27(4):euaf080. doi: 10.1093/europace/euaf080.
- Derived from this study: PubMed 35717354Handelsman Y, Bunch TJ, Rodbard HW, Steinberg BA, Thind M, Bigot G, Konigsberg L, Wieloch M, Kowey PR. Impact of dronedarone on patients with atrial fibrillation and diabetes: A sub-analysis of the ATHENA and EURIDIS/ADONIS studies. J Diabetes Complications. 2022 Jul;36(7):108227. doi: 10.1016/j.jdiacomp.2022.108227. Epub 2022 Jun 8.
- Derived from this study: PubMed 34958366Vamos M, Oldgren J, Nam GB, Lip GYH, Calkins H, Zhu J, Ueng KC, Ludwigs U, Wieloch M, Stewart J, Hohnloser SH. Dronedarone vs. placebo in patients with atrial fibrillation or atrial flutter across a range of renal function: a post hoc analysis of the ATHENA trial. Eur Heart J Cardiovasc Pharmacother. 2022 Jun 8;8(4):363-371. doi: 10.1093/ehjcvp/pvab090.
- Derived from this study: PubMed 22770643Akerborg O, Nilsson J, Bascle S, Lindgren P, Reynolds M. Cost-effectiveness of dronedarone in atrial fibrillation: results for Canada, Italy, Sweden, and Switzerland. Clin Ther. 2012 Aug;34(8):1788-802. doi: 10.1016/j.clinthera.2012.06.007. Epub 2012 Jul 6.
- Derived from this study: PubMed 21576129Torp-Pedersen C, Crijns HJ, Gaudin C, Page RL, Connolly SJ, Hohnloser SH; ATHENA Investigators. Impact of dronedarone on hospitalization burden in patients with atrial fibrillation: results from the ATHENA study. Europace. 2011 Aug;13(8):1118-26. doi: 10.1093/europace/eur102. Epub 2011 May 15.
- Derived from this study: PubMed 21296333Page RL, Connolly SJ, Crijns HJ, van Eickels M, Gaudin C, Torp-Pedersen C, Hohnloser SH; ATHENA Investigators. Rhythm- and rate-controlling effects of dronedarone in patients with atrial fibrillation (from the ATHENA trial). Am J Cardiol. 2011 Apr 1;107(7):1019-22. doi: 10.1016/j.amjcard.2010.11.028. Epub 2011 Feb 4.
- Derived from this study: PubMed 20436046Hohnloser SH, Crijns HJ, van Eickels M, Gaudin C, Page RL, Torp-Pedersen C, Connolly SJ; ATHENA Investigators. Dronedarone in patients with congestive heart failure: insights from ATHENA. Eur Heart J. 2010 Jul;31(14):1717-21. doi: 10.1093/eurheartj/ehq113. Epub 2010 Apr 30.
- Related InfoLink provided by the sponsor.
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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.
International Clinical Development study director
Sanofi
37 sites in 37 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dronedarone (SR33589) in people with Atrial Fibrillation and Atrial Flutter, run by Sanofi at 37 sites in 37 countries.
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 19 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: finished, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Argentina, Australia, Austria, Belgium and 32 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Hospitalization for Cardiovascular Reason or Death From Any Cause (time frame: minimum follow-up duration: 1 year ; maximum: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00174785, which also lists 10 linked publications.
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 12 Jan 2010.