Myocardial IschemiaPhase 3NCT00296218
ARCHIPELAGO: Irbesartan in Patients With Acute Coronary Syndrome Without ST Segment Elevation
A Phase 3 study testing Irbesartan in people with Myocardial Ischemia and Hypertension, run by Sanofi at 11 sites in 11 countries.
Trial summary
Primary Objective The main objective of this study is to assess if a two-month regimen of irbesartan in patients hospitalized for acute coronary syndrome without ST segment elevation can reduce inflammation markers (ie hsCRP), in comparison to a similar regimen of enalapril. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Hypertension
- What is being tested?
- Irbesartan
- How many people
- 440 participants
- Where
- 11 sitesin 11 countries
- Study dates
- Feb 2006to Mar 2007
- Phase
- Phase 3
- 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
- Patient hospitalised with ischemic symptoms (last episode within the last 48 hours before randomization) and at least one of the following characteristics of NSTEACS (non-ST-segment-elevation acute coronary syndromes):
- ECG ST or T changes (ST depression or transient elevation of at least 1mm or T wave changes in at least 2 leads)
- Positive troponin (according to local threshold)
Who cannot join
- Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study WOCBP using a prohibited contraceptive method (not applicable)
- Women who are pregnant or breast feeding
- Women with a positive pregnancy test on enrolment or prior to study drug administration
- Patient with dementia
- Persistent ST segment elevation at ECG
- Systolic blood pressure < 100 mmHg
Show all 25Show fewer
- Bilateral stenosis of renal artery
- Creatinine clearance < or = 30ml/mn
- Congestive heart failure with symptoms consistent with New York Heart Association (NYHA) class III or IV.
- Aortic or mitral valve stenosis
- Hypertrophic cardiomyopathy
- Connective tissue disease with vascular involvement
- Angioplasty, surgery or trauma within the last 3 months
- Coronarography or angioplasty planned to be performed or performed before baseline sampling
- Febrile (≥ 38°C) disease, known concomitant viral or bacterial infection, chronic auto immune disease, chronic inflammatory disease, known cancer in evolution
- Hyperkalemia: serum potassium > 5.5mmol/l
- Sensitivity or intolerance to Angiotensin receptor blockers (ARBs) : olmesartan, candesartan, irbesartan, eprosartan, losartan, telmisartan, valsartan and/or any other ARB currently or previously in development.
- Sensitivity or intolerance to Angiotensin-converting Enzyme Inhibitors (ACE-I) : benazepril, captopril, enalapril, lisinopril, trandolapril, ramipril, quinapril, and/or any other ACE-I currently or previously in development.
- Chronic steroid or non-steroidal anti inflammatory drugs (NSAIDs) use. Aspirin is permitted.
- Treatment with allopurinol or procaïnamide
- Concomitant use of potassium sparing diuretics (eg. spironolactone, triamterene or amiloride), potassium preparations or salt substitutes containing potassium
- Treatment with Lithium
- Immunosupressive medication
- Administration of any other investigational drug in the last 30 days before enrolment and during the course of the study
- Treatment with ARB or ACE inhibitor within the last 3 days.
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
About this study
Official title: Randomized Comparison of a Two-month Regimen of Irbesartan Versus Enalapril on Cardiovascular Markers in Patients With Acute Coronary Syndrome Without ST Segment Elevation.
Primary Objective
- The main objective of this study is to assess if a two-month regimen of irbesartan in patients hospitalized for acute coronary syndrome without ST segment elevation can reduce inflammation markers (ie hsCRP), in comparison to a similar regimen of enalapril.
Secondary Objectives
- To compare both regimens on several other biological parameters which have demonstrated their relevance and their predictive clinical value (ie BNP, microalbuminuria, troponin I …) in this patient population.
- To compare on the above parameters the early initiation of treatment versus the initiation of treatment at hospital discharge.
- Conditions
- Myocardial Ischemia, Hypertension
- Being tested
- Irbesartan
- Medical subject headings
- Myocardial Ischemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrbesartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups
Secondary outcomes (7)
Relative change from baseline of hsCRP at discharge
Changes from baseline in BNP and Microalbuminuria (MAU) at discharge and day 60
Change of Troponin I from baseline at discharge
In addition at baseline, discharge and D60 the following parameters will be evaluated and their evolution compared in the two treatment groups: IL6, CD 40 L, sPLA2 and Lp-PLA2, IMA, MMP-9, MPO (myeloperoxydase), aldosterone
Blood pressure at discharge, D15 and D60.
The early versus late (at hospital discharge) initiation of treatment will also be evaluated on the above-listed parameters.
& Safety outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 440 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Catherine Domenger, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296218
- Sponsor's protocol ID
- PM_C_0024
- Other IDs
- EudraCT #: 2005-002161-36
- Status last verified
- Oct 2009
- First submitted
- 22 Feb 2006
- Last updated
- 15 Oct 2009
- Results posted
- No
Publications
Montalescot G, Drexler H, Gallo R, Pearson T, Thoenes M, Bhatt DL. Effect of irbesartan and enalapril in non-ST elevation acute coronary syndrome: results of the randomized, double-blind ARCHIPELAGO study. Eur Heart J. 2009 Nov;30(22):2733-41. doi: 10.1093/eurheartj/ehp301. Epub 2009 Aug 21.
PubMed 19700470
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of a Two-month Regimen of Irbesartan Versus Enalapril on Cardiovascular Markers in Patients With Acute Coronary Syndrome Without ST Segment Elevation.
- ClinicalTrials.gov ID
- NCT00296218
- Acronym / sponsor ID
- PM_C_0024
- Conditions
- Myocardial Ischemia, Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Feb 2006
- Primary completion
- Mar 2007 (actual)
- First posted
- 24 Feb 2006 (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.
Primary Objective
- The main objective of this study is to assess if a two-month regimen of irbesartan in patients hospitalized for acute coronary syndrome without ST segment elevation can reduce inflammation markers (ie hsCRP), in comparison to a similar regimen of enalapril.
Secondary Objectives
- To compare both regimens on several other biological parameters which have demonstrated their relevance and their predictive clinical value (ie BNP, microalbuminuria, troponin I …) in this patient population.
- To compare on the above parameters the early initiation of treatment versus the initiation of treatment at hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient hospitalised with ischemic symptoms (last episode within the last 48 hours before randomization) and at least one of the following characteristics of NSTEACS (non-ST-segment-elevation acute coronary syndromes):
Key exclusion criteria (25 listed)
- Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study WOCBP using a prohibited contraceptive method (not applicable)
- Women who are pregnant or breast feeding
- Women with a positive pregnancy test on enrolment or prior to study drug administration
- Patient with dementia
- Persistent ST segment elevation at ECG
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 |
|---|---|---|
| Irbesartan | Drug | – |
Primary outcome
comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups
7 secondary outcomes
Relative change from baseline of hsCRP at discharge
Changes from baseline in BNP and Microalbuminuria (MAU) at discharge and day 60
Change of Troponin I from baseline at discharge
In addition at baseline, discharge and D60 the following parameters will be evaluated and their evolution compared in the two treatment groups: IL6, CD 40 L, sPLA2 and Lp-PLA2, IMA, MMP-9, MPO (myeloperoxydase), aldosterone
Blood pressure at discharge, D15 and D60.
The early versus late (at hospital discharge) initiation of treatment will also be evaluated on the above-listed parameters.
& Safety outcomes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2009.
- Results publication: PubMed 19700470Montalescot G, Drexler H, Gallo R, Pearson T, Thoenes M, Bhatt DL. Effect of irbesartan and enalapril in non-ST elevation acute coronary syndrome: results of the randomized, double-blind ARCHIPELAGO study. Eur Heart J. 2009 Nov;30(22):2733-41. doi: 10.1093/eurheartj/ehp301. Epub 2009 Aug 21.
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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.
Catherine Domenger, MD study director
Sanofi
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irbesartan in people with Myocardial Ischemia and Hypertension, run by Sanofi at 11 sites in 11 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 3 inclusion and 25 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 15 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Belgium, Canada, France, Germany and 6 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups. 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 NCT00296218, which also lists 1 linked publication.
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 15 Oct 2009.