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Stable AnginaSENIORNCT02099617

Efficacy and Safety of New Generation Drug Eluting Stents Associated With an Ultra Short Duration of Dual Antiplatelet Therapy. Design of the Short Duration of Dual antiplatElet Therapy With SyNergy II Stent in Patients Older Than 75 Years Undergoing Percutaneous Coronary Revascularization.

A study testing Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent, Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent and Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent in people with Stable Angina and Silent Myocardial Ischemia, run by Ceric Sàrl at 44 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main objective of the SENIOR study is to establish the efficacy and safety of the everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with a short dual antiplatelet therapy (DAPT) in patients ≥75 years old, suffering from stable angina, silent ischemia (1 month DAPT) or acute… Read more about this study

Who is it for?
Ages 75 years and older
What is being tested?
Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent, Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent and Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
44 sitesin 9 countries
Study dates
May 2014to Jun 2018
Phase
Interventional
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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 1- Patient is ≥ 75 years old
  • 2- One or more significant coronary artery stenosis is/are present (defined as ≥70% by visual assessment or ≥50% with Fractional Flow Reserve <0.80) or a left main coronary stenosis ≥50% by visual assessment) suitable for PCI with one of the following present:
  • a -Silent ischemia,
  • stress-induced myocardial ischemia ≥ 10% of myocardium in a asymptomatic patient or
  • stress-induced myocardial ischemia < 10% of myocardium AND FFR (Fractional Flow Reserve) ≤0.80 or
  • b - Stable angina, in a patient with objective ischemia despite optimal medical therapy or
  • c - acute coronary syndrome including: unstable angina, non ST- and ST elevation myocardial infarction.
  • 3- All patients must also sign informed consent as per local law and comply with all study process during follow up for at least one year.

Who cannot join

  • 1- The subject is not eligible for randomization if ANY of the following is present:
  • 2- Indication for myocardial revascularization by coronary artery bypass grafting,
  • 3- Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one month (stable angina or silent ischemia) or at least six month (acute coronary syndrome),
  • 4- Subjects requiring additional surgery (cardiac or non-cardiac) within one month,
  • 5- Non cardiac co-morbidities with life expectancy less than 1 year,
  • 6- Prior hemorrhagic stroke,
Show all 10Show fewer
  • 7- Known allergy to aspirin or P2Y12 inhibitors,
  • 8- At least one contra indication to ALL the authorized P2Y12 inhibitors at the requested dose (in case of contra indication to only one of two of the P2Y12 inhibitors, the investigators are allowed to use the P2Y12 inhibitors for which no allergy is known).
  • 9- Silent ischemia <10% of the myocardium with FFR ≥0.80.
  • 10- Participation in another clinical trial

Trial locations and contacts

44 sites in 9 countries.

44 sites in 9 countries

Spain13 sites

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, 08003

  • Hospital San Juan de Alicante

    Alicante, Valencia

  • Hospital Universati Germans Trias i Pujol

    Badalona

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clinic

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant pau

    Barcelona

  • Hospital Juan Roamon Jimenez

    Huelva, 21005

  • Hospital Universitario virgen de la arrixaca

    Murcia, 30107

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital universitario Marquès de Valdecilla

    Santander, Cantabria, 39008

  • Hospital virgen de la salud.

    Toledo, 45071

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47005

  • Hospital Meixoiero

    Vigo, 36200

Other trials in Spain

France11 sites

  • Hôpital Ambroise Paré

    Boulogne-Billancourt, 92100

  • Hôpital Henri Mondor

    Créteil, 94000

  • Hôpital de la Timone

    Marseille, 13005

  • Hôpital Privé Jacques Cartier

    Massy, 91300

  • Polyclinique les Fleurs

    Ollioules, 83 190

  • Hôpital Lariboisière

    Paris, 75010

  • Hôpital La Pitié-Salpêtrière

    Paris, 75013

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • Hôpital Privé Claude Galien

    Quincy-sous-Sénart, 91480

  • CHU Toulouse Rangueil

    Toulouse, 31400

Other trials in France

United Kingdom6 sites

  • Brighton and Sussex Hospitals

    Brighton, BN2 1ES

  • Craigavon Cardiac Center

    Craigavon, BT62 5QQ

  • Guy's and St.Thomas'Hospitals

    London, SE1 7EH

  • King's College London

    London, SE5 9PJ

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Switzerland5 sites

  • Hôpital Fribourgeois

    Fribourg, 1708

  • Centre hospitalier universitaire vaudois

    Lausanne, 1011

  • Luzerner Kantonsspital

    Lucerne, 6000

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

  • Kantonsspital Winterthur

    Winterthur

Other trials in Switzerland

Belgium4 sites

  • CHU St Pierre

    Brussels, 1150

  • Centre Hospitalier de Jolimont

    La Louvière, 7100

  • UZ Leuven

    Leuven, 3000

  • CHU de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000

Other trials in Belgium

Finland2 sites

  • Oulu University Hospital

    Oulu, 90220

  • Heary Center - Satakunta Centyral Hospital

    Pori

Other trials in Finland

Italy1 site

  • ARNAS civico

    Palermo, 90127

Other trials in Italy

Latvia1 site

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002

Other trials in Latvia

North Macedonia1 site

  • University Clinic of Cardiology - Medical Faculty

    Skopje, 1000

Other trials in North Macedonia

About this study

The main objective of the SENIOR study is to establish the efficacy and safety of the everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with a short dual antiplatelet therapy (DAPT) in patients ≥75 years old, suffering from stable angina, silent ischemia (1 month DAPT) or acute coronary syndromes (6 months DAPT) related to significant coronary artery disease and requiring percutaneous coronary intervention. The primary end point is to demonstrate that SYNERGY II in patients ≥75 years old is associated with a lower rate of the composite rate of major cardiovascular and cerebrovascular events (all-cause death, myocardial infarction, stroke, ischemia-driven target lesion revascularization) and a similar risk of stent thrombosis than bare metal stent at one year.

Being tested
Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent, Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent, Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent
Medical subject headings
Angina, Stable, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stentProcedure or surgery

  • Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stentProcedure or surgery

  • Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stentProcedure or surgery

Study groups in NCT02099617
Study groupRoleWhat they receive
Drug Eluting StentExperimentalSynergy II
Receives: Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent
Bare Metal StentActive comparatorOmega or Rebel
Receives: Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent; Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite measure of MACCEs (Major Adverse Cardiac and Cerebrovascular Events)

    all-cause death, non fatal myocardial infarction, non fatal stroke, ischemia-driven target lesion revascularization.

    Measured: 12 months

Secondary outcomes (9)

  1. Primary endpoint

    Measured: 30 days, 180 days, 2 years

  2. All revascularizations

    All target lesion revascularization, all target vessel revascularization, all non target vessel revascularization

    Measured: 30 days, 180 days, 1 year, 2 years

  3. Complete revascularization

    anatomic and functional

    Measured: Baseline procedure

  4. Net benefit

    association of composite events (all cause mortality, myocardial infarction, stroke, ischemia driven target lesion revascularization, and major bleedings)

    Measured: 30 days, 180 daysn 1 year, 2 years

  5. Major bleedings complications

    type 2, 3 and 5 BARC definition)

    Measured: 30 days, 180 days, 1 year, 2 years

  6. Stent thombosis

    according to the definition of ARC symptomatic or asymptomatic (definite + probable)

    Measured: 30 days, 1 year, 2 years

  7. QoL

    Measured: 12 months, 24 months

  8. Depression scale

    Measured: 12 months, 24 months

  9. Cost effectiveness

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionJul 2017
  4. Study completionJun 2018

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02099617
Sponsor's protocol ID
10-389
Acronym
SENIOR
Status last verified
May 2017
First submitted
24 Mar 2014
Last updated
16 Jan 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Varenne O, Cook S, Sideris G, Kedev S, Cuisset T, Carrie D, Hovasse T, Garot P, El Mahmoud R, Spaulding C, Helft G, Diaz Fernandez JF, Brugaletta S, Pinar-Bermudez E, Mauri Ferre J, Commeau P, Teiger E, Bogaerts K, Sabate M, Morice MC, Sinnaeve PR; SENIOR investigators. Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial. Lancet. 2018 Jan 6;391(10115):41-50. doi: 10.1016/S0140-6736(17)32713-7. Epub 2017 Nov 1.

    PubMed 29102362

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent, Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent and Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent in people with Stable Angina and Silent Myocardial Ischemia, run by Ceric Sàrl at 44 sites in 9 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 10 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 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Spain, France, United Kingdom, Switzerland, Belgium and 4 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.

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?

Composite measure of MACCEs (Major Adverse Cardiac and Cerebrovascular Events) (time frame: 12 months). 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 NCT02099617, 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 16 Jan 2024.

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