Ehlers-Danlos Syndrome, Vascular TypePhase 3ARCADENCT02597361
Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome (ARCADE)
A Phase 3 study testing Irbesartan in people with Ehlers-Danlos Syndrome, Vascular Type, run by Assistance Publique - Hôpitaux de Paris at 15 sites in France.
Trial summary
This study aims to verify the hypothesis that patients with Vascular Ehlers Danlos syndrome (vEDS) should benefit of the blockade of angiotensin (Ang) II noxious effects on their vasculature affected by a defect in type III collagen in addition to the effects celiprolol. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ehlers-Danlos Syndrome, Vascular Type
- 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
- 61 participants
- Where
- 15 sitesFrance
- Study dates
- Jan 2016to 19 Feb 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with genetically-proven vEDS (presence of a pathogenic mutation at the COL3A1 gene);
- Age ≥18 years and <70 years;
- Men and women with reliable contraception or negative beta-HCG at screening;
- Celiprolol at the optimal tolerated dose since at least 12 weeks;
- vEDS patient fully intolerant to celiprolol but not treated with any other drug active on the vascular system, except another beta-blocker;
- No compelling indication for ARB therapy (renal infarction, hypertension, proteinuric nephropathy, chronic heart failure, myocardial infarction, stroke);
Show all 9Show fewer
- Estimated glomerular filtration rate (GFR) ≥ 30ml/min/1,73m2 (MDRD Formula);
- Normal or clinically acceptable 12-lead ECG;
- Written informed consent to participate in the study.
Who cannot join
- General criteria
- Unlikely to co-operate in the study and/or poor compliance anticipated by the investigator, e.g., uncooperative attitude, inability to return for follow-up visit, and unlikelihood of completing the study;
- Participation in another interventional therapeutic study at the same time or within 3 months prior to the beginning of the present study;
- Participant not affiliated to the French social security;
- No written informed consent;
- Severe contrast media allergy, not amenable to pre-treatment Medical and therapeutic criteria
Show all 16Show fewer
- History of previous symptomatic visceral complication (any CV event, pulmonary or digestive event) in the 3 months preceding the inclusion;
- Formal indication for an antihypertensive medication (office BP ≥140/90 mmHg on celiprolol on at least two separated visits, confirmed by daytime ambulatory BP or home BP ≥ 135/85 mmHg);
- Concomitant treatment with renin-angiotensin-aldosterone system blocking agents apart from the study drug, e.g. ACEI, ARB or aldosterone-antagonist or any renin inhibitor, if given for an elective indication (heart failure, renal infarction, chronic kidney disease, proteinuria, myocardial infarction, stroke);
- Any cardiac condition that justifies a specific medical care (i.e. second or third degree auriculo-ventricular block, potentially life threatening arrhythmia or other uncontrolled arrhythmia or persistent arrhythmia, clinically significant valvular heart disease);
- Known significant renal artery stenosis with evidence of renal ischemia (on Duplex ultrasound, CTA, or other exam);
- Any concurrent life threatening condition other than vEDS with a life expectancy less than 2 years;
- Likely allergy or hypersensitivity to irbesartan, based on known allergies to drugs of the same class, or which in the opinion of the investigator suggests an increased potential for an adverse hypersensitivity as well as known or suspected contraindications to the study drug;
- Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety;
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin (hCG) laboratory test (>5 mIU/ml);
- Women of child-bearing potential (WOCBP) without reliable contraception.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
CHU DE BORDEAUX - Hopital Saint Andre
Bordeaux, 33075
CHU DE LYON - Hopital Femme Mere Enfant
Bron, 69500
CHU DE CAEN - Hopital Cote de Nacre
Caen, 14033
CHU DE TOURS - Hopital Trousseau
Chambray-lès-Tours, 37044
CHU DE GRENOBLE - Hopital Albert Michallon
Grenoble, 38043
CHU DE GRENOBLE - Hopital Couple Enfant
Grenoble, 38043
CHRU DE LILLE - Hopital Claude Huriez
Lille, 59000
CHU DE LYON - Hopital Edouard Herriot
Lyon, 69003
AP-HM - Hopital de la Timone
Marseille, 13385
CHU DE MONTPELLIER - Hopital Saint Eloi
Montpellier, 34295
CHU DE NANTES - Hopital Hotel-Dieu
Nantes, 44300
AP-HP - Hopital Europeen Georges-Pompidou
Paris, 75015
CHU DE TOULOUSE - Hopital Purpan
Toulouse, 31059
CHU DE TOULOUSE - Hopital Rangueil
Toulouse, 31059
CHRU DE NANCY - Institut Lorrain du Coeur et des Vaisseaux
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome: a Double Blind, Randomized, Placebo Controlled, Multicenter Trial.
This study aims to verify the hypothesis that patients with Vascular Ehlers Danlos syndrome (vEDS) should benefit of the blockade of angiotensin (Ang) II noxious effects on their vasculature affected by a defect in type III collagen in addition to the effects celiprolol. This randomized, double blind, placebo controlled trial compares the administration of the Ang II type I receptor blocker (ARB) - irbesartan- to placebo over a 2-year period in vEDS patients with the main objective to reduce the incidence of both symptomatic and asymptomatic vascular events.
Read the detailed description
vEDS is a rare life-threatening inherited condition due to mutations at the COL3A1 gene encoding the pro-alpha 1 chain of type III procollagen (OMIM #130050) with unpredictable and recurring arterial dissections/aneurysms starting in the early adulthood. The investigators have previously shown that a treatment with 200-400 mg per day of celiprolol, reduces both fatal and non-fatal vascular events in patients with vEDS. If tolerated, the treatment is now the standard treatment for vEDS. However, despite celiprolol , symptomatic and asymptomatic arterial events continue to occur in vEDS patients. Recent findings suggest a possible deleterious effect of endogenous Angiotensin II on medium size arteries in vEDS patients. The hypothesis of this study is that the blockade of endogenous Ang II will provide supplemental vascular protection and thus reduce recurrence of arterial events in vEDS patients.
The primary objective of this study is to determine in patients with molecularly proven vEDS, whether an Ang II receptor blocker, prescribed at an optimally tolerated dose combined with the reference celiprolol treatment, decreases the 24 months rate of both asymptomatic and symptomatic cardiovascular (CV) events when compared to placebo.
Methodology:
Multicenter, double-blind, randomized (1:1), placebo-controlled, parallel group, study with blind endpoint evaluation in adult vEDS patients.
Main criteria for inclusion:
Patients of both sexes aged 18 to 70 years with molecularly proven vEDS, not in an acute phase of the disease, with no contra-indication for taking an Ang II blocker.
- Conditions
- Ehlers-Danlos Syndrome, Vascular Type
- Being tested
- Irbesartan, Placebo
- Keywords
- Ehlers-Danlos syndrome, vascular type, Type 2 Angiotensin Receptor Blockers
- Medical subject headings
- Ehlers-Danlos Syndrome, Type IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrbesartanDrug
Irbesartan: 150 or 300 mg o.d. The up-titration of irbesartan from 150 mg to 300 mg o.d. occur during the first 8 weeks following randomization
PlaceboDrug
Placebo o.d. to match 150mg or 300mg irbesartan tablets
| Study group | Role | What they receive |
|---|---|---|
| Irbesartan | Active comparator | Irbesartan: 150 or 300 mg o.d. for 2 years.The up-titration of irbesartan from 150 mg to 300 mg o.d. occurs during the first 8 weeks following randomization and will be driven by clinical, hemodynamic and biological (plasma creatinine and K) tolerability. Receives: Drug: Irbesartan |
| Placebo | Placebo comparator | Placebo once or twice per day for 2 years. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular morbidity and mortality
Total number of any non-fatal and fatal cardiovascular events or events related to vEDS
Measured: 2 years
Arterial lesions
number and severity of arterial lesions detected by CTA
Measured: 2 years
Secondary outcomes (13)
Rate of any symptomatic cardiovascular event
CV death; any morbid and fatal events related to vEDS; Any non fatal CV event; Non-fatal stroke
Measured: 2 years
Occurrence of new asymptomatic arterial lesions (aneurysm, dissection), detected by a systematic CTA
Arterial dissection/rupture/aneurysm in any vascular bed
Measured: 2 years
Time to first symptomatic clinical morbid and fatal events
Measured: 2 years
Number of unplanned hospitalization for any vEDS related event
Measured: 2 years
Total number of arterial lesions detected by vascular DUS
Echo duplex ultrasound made at inclusion, 6, 12, 18 and 24 months
Measured: 2 years
Total number of arterial lesions worsened during follow-up
Measured: 2 years
Changes in PWV (Pulse Wave Velocity)
Applanation tonometry made at randomization visit, 6, 12, 18 and 24 months
Measured: 2 years
Changes in large arteries properties (diameter, wall stress, stiffness)
Echotracking made at randomization visit, 6, 12, 18 and 24 months
Measured: 2 years
Decrease in office systolic/diastolic BP
Vital signs (BP and HR) measured by automatic device at each visit
Measured: 2 years
Change in estimated glomerular filtration rate (MDRD)
eGFR evaluated at each visit
Measured: 2 years
Tolerability and safety of the irbesartan assessed by orthostatic hypotension, plasma creatinine, plasma K+ evaluated at each visit
Measured: 2 years
Compliance to treatment
Spot urine for drug determination (celiprolol and irbesartan urinary detection) made at randomization visit and 3, 12 and 24 months
Measured: 2 years
Quality of life
SF36 and HADS questionnaires submitted to participants at randomization visit, 6, 12 and 24 months
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startJan 2016
- Primary completion19 Feb 2020
- Study completion19 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ehlers-Danlos Syndrome, Vascular TypeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Xavier JEUNEMAITRE, MD,PHD, Principal investigator, AP-HP, INSERM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597361
- Sponsor's protocol ID
- P140918
- Other IDs
- 2015-001065-76, 2015
- Acronym
- ARCADE
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2015
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results reported in publications after de-identification (text, tables, figures, and appendices). IPD detailed in the protocol of a planned meta-analysis could be shared.
Publications
Frank M, Albuisson J, Ranque B, Golmard L, Mazzella JM, Bal-Theoleyre L, Fauret AL, Mirault T, Denarie N, Mousseaux E, Boutouyrie P, Fiessinger JN, Emmerich J, Messas E, Jeunemaitre X. The type of variants at the COL3A1 gene associates with the phenotype and severity of vascular Ehlers-Danlos syndrome. Eur J Hum Genet. 2015 Dec;23(12):1657-64. doi: 10.1038/ejhg.2015.32. Epub 2015 Mar 11.
PubMed 25758994Faugeroux J, Nematalla H, Li W, Clement M, Robidel E, Frank M, Curis E, Ait-Oufella H, Caligiuri G, Nicoletti A, Hagege A, Messas E, Bruneval P, Jeunemaitre X, Bergaya S. Angiotensin II promotes thoracic aortic dissections and ruptures in Col3a1 haploinsufficient mice. Hypertension. 2013 Jul;62(1):203-8. doi: 10.1161/HYPERTENSIONAHA.111.00974. Epub 2013 Apr 29.
PubMed 23630948Ong KT, Perdu J, De Backer J, Bozec E, Collignon P, Emmerich J, Fauret AL, Fiessinger JN, Germain DP, Georgesco G, Hulot JS, De Paepe A, Plauchu H, Jeunemaitre X, Laurent S, Boutouyrie P. Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial. Lancet. 2010 Oct 30;376(9751):1476-84. doi: 10.1016/S0140-6736(10)60960-9. Epub 2010 Sep 7.
PubMed 20825986Jeunemaitre X, Mousseaux E, Frank M, Adham S, Pitocco F, Billon C, Ben Yakhlef M, El Hachmi M, Bura-Riviere A, Lapebie FX, Le Hello C, Laneelle D, Seinturier C, Dieterich K, Lambert M, Dupuis-Girod S, Zuily S, Bal-Theoleyre L, Boulon C, Henneton P, Lu E, Denarie N, Boutouyrie P, Mirault T, Chatellier G, Azizi M. Efficacy of Irbesartan in Celiprolol-Treated Patients With Vascular Ehlers-Danlos Syndrome. Circulation. 2025 Mar 11;151(10):686-695. doi: 10.1161/CIRCULATIONAHA.124.072849. Epub 2025 Feb 5.
PubMed 39906986
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome: a Double Blind, Randomized, Placebo Controlled, Multicenter Trial.
- ClinicalTrials.gov ID
- NCT02597361
- Acronym / sponsor ID
- ARCADE / P140918
- Conditions
- Ehlers-Danlos Syndrome, Vascular Type
- Keywords
- Ehlers-Danlos syndrome, vascular type, Type 2 Angiotensin Receptor Blockers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jan 2016 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 5 Nov 2015 (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.
This study aims to verify the hypothesis that patients with Vascular Ehlers Danlos syndrome (vEDS) should benefit of the blockade of angiotensin (Ang) II noxious effects on their vasculature affected by a defect in type III collagen in addition to the effects celiprolol. This randomized, double blind, placebo controlled trial compares the administration of the Ang II type I receptor blocker (ARB) - irbesartan- to placebo over a 2-year period in vEDS patients with the main objective to reduce the incidence of both symptomatic and asymptomatic vascular events.
Detailed description
vEDS is a rare life-threatening inherited condition due to mutations at the COL3A1 gene encoding the pro-alpha 1 chain of type III procollagen (OMIM #130050) with unpredictable and recurring arterial dissections/aneurysms starting in the early adulthood. The investigators have previously shown that a treatment with 200-400 mg per day of celiprolol, reduces both fatal and non-fatal vascular events in patients with vEDS. If tolerated, the treatment is now the standard treatment for vEDS. However, despite celiprolol , symptomatic and asymptomatic arterial events continue to occur in vEDS patients. Recent findings suggest a possible deleterious effect of endogenous Angiotensin II on medium size arteries in vEDS patients. The hypothesis of this study is that the blockade of endogenous Ang II will provide supplemental vascular protection and thus reduce recurrence of arterial events in vEDS patients.
The primary objective of this study is to determine in patients with molecularly proven vEDS, whether an Ang II receptor blocker, prescribed at an optimally tolerated dose combined with the reference celiprolol treatment, decreases the 24 months rate of both asymptomatic and symptomatic cardiovascular (CV) events when compared to placebo.
Methodology:
Multicenter, double-blind, randomized (1:1), placebo-controlled, parallel group, study with blind endpoint evaluation in adult vEDS patients.
Main criteria for inclusion:
Patients of both sexes aged 18 to 70 years with molecularly proven vEDS, not in an acute phase of the disease, with no contra-indication for taking an Ang II blocker.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irbesartan | Active comparator | Drug: IrbesartanIrbesartan: 150 or 300 mg o.d. for 2 years.The up-titration of irbesartan from 150 mg to 300 mg o.d. occurs during the first 8 weeks following randomization and will be driven by clinical, hemodynamic and biological (plasma creatinine and K) tolerability. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once or twice per day for 2 years. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with genetically-proven vEDS (presence of a pathogenic mutation at the COL3A1 gene);
- Age ≥18 years and <70 years;
- Men and women with reliable contraception or negative beta-HCG at screening;
- Celiprolol at the optimal tolerated dose since at least 12 weeks;
- vEDS patient fully intolerant to celiprolol but not treated with any other drug active on the vascular system, except another beta-blocker;
Key exclusion criteria (16 listed)
- General criteria
- Unlikely to co-operate in the study and/or poor compliance anticipated by the investigator, e.g., uncooperative attitude, inability to return for follow-up visit, and unlikelihood of completing the study;
- Participation in another interventional therapeutic study at the same time or within 3 months prior to the beginning of the present study;
- Participant not affiliated to the French social security;
- No written informed consent;
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 |
|---|---|---|
| IrbesartanIrbesartan: 150 or 300 mg o.d. The up-titration of irbesartan from 150 mg to 300 mg o.d. occur during the first 8 weeks following randomization | Drug | Irbesartan |
| PlaceboPlacebo o.d. to match 150mg or 300mg irbesartan tablets | Drug | Placebo |
Primary outcome
Cardiovascular morbidity and mortality
Time frame: 2 years
Total number of any non-fatal and fatal cardiovascular events or events related to vEDS
Arterial lesions
Time frame: 2 years
number and severity of arterial lesions detected by CTA
13 secondary outcomes
Rate of any symptomatic cardiovascular event
Time frame: 2 years
Occurrence of new asymptomatic arterial lesions (aneurysm, dissection), detected by a systematic CTA
Time frame: 2 years
Time to first symptomatic clinical morbid and fatal events
Time frame: 2 years
Number of unplanned hospitalization for any vEDS related event
Time frame: 2 years
Total number of arterial lesions detected by vascular DUS
Time frame: 2 years
Total number of arterial lesions worsened during follow-up
Time frame: 2 years
Changes in PWV (Pulse Wave Velocity)
Time frame: 2 years
Changes in large arteries properties (diameter, wall stress, stiffness)
Time frame: 2 years
Decrease in office systolic/diastolic BP
Time frame: 2 years
Change in estimated glomerular filtration rate (MDRD)
Time frame: 2 years
Tolerability and safety of the irbesartan assessed by orthostatic hypotension, plasma creatinine, plasma K+ evaluated at each visit
Time frame: 2 years
Compliance to treatment
Time frame: 2 years
Quality of life
Time frame: 2 years
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 29 Feb 2024.
- Background: PubMed 25758994Frank M, Albuisson J, Ranque B, Golmard L, Mazzella JM, Bal-Theoleyre L, Fauret AL, Mirault T, Denarie N, Mousseaux E, Boutouyrie P, Fiessinger JN, Emmerich J, Messas E, Jeunemaitre X. The type of variants at the COL3A1 gene associates with the phenotype and severity of vascular Ehlers-Danlos syndrome. Eur J Hum Genet. 2015 Dec;23(12):1657-64. doi: 10.1038/ejhg.2015.32. Epub 2015 Mar 11.
- Results publication: PubMed 23630948Faugeroux J, Nematalla H, Li W, Clement M, Robidel E, Frank M, Curis E, Ait-Oufella H, Caligiuri G, Nicoletti A, Hagege A, Messas E, Bruneval P, Jeunemaitre X, Bergaya S. Angiotensin II promotes thoracic aortic dissections and ruptures in Col3a1 haploinsufficient mice. Hypertension. 2013 Jul;62(1):203-8. doi: 10.1161/HYPERTENSIONAHA.111.00974. Epub 2013 Apr 29.
- Results publication: PubMed 20825986Ong KT, Perdu J, De Backer J, Bozec E, Collignon P, Emmerich J, Fauret AL, Fiessinger JN, Germain DP, Georgesco G, Hulot JS, De Paepe A, Plauchu H, Jeunemaitre X, Laurent S, Boutouyrie P. Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial. Lancet. 2010 Oct 30;376(9751):1476-84. doi: 10.1016/S0140-6736(10)60960-9. Epub 2010 Sep 7.
- Derived from this study: PubMed 39906986Jeunemaitre X, Mousseaux E, Frank M, Adham S, Pitocco F, Billon C, Ben Yakhlef M, El Hachmi M, Bura-Riviere A, Lapebie FX, Le Hello C, Laneelle D, Seinturier C, Dieterich K, Lambert M, Dupuis-Girod S, Zuily S, Bal-Theoleyre L, Boulon C, Henneton P, Lu E, Denarie N, Boutouyrie P, Mirault T, Chatellier G, Azizi M. Efficacy of Irbesartan in Celiprolol-Treated Patients With Vascular Ehlers-Danlos Syndrome. Circulation. 2025 Mar 11;151(10):686-695. doi: 10.1161/CIRCULATIONAHA.124.072849. Epub 2025 Feb 5.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results reported in publications after de-identification (text, tables, figures, and appendices). IPD detailed in the protocol of a planned meta-analysis could be shared.
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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.
Xavier JEUNEMAITRE, MD,PHD principal investigator
AP-HP, INSERM
15 sites in 1 country: 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 Ehlers-Danlos Syndrome, Vascular Type, run by Assistance Publique - Hôpitaux de Paris at 15 sites in France.
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 9 inclusion and 16 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 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. 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?
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?
Cardiovascular morbidity and mortality (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT02597361, which also lists 4 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 29 Feb 2024.