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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. (SENIOR)

Primary Purpose

Stable Angina, Silent Myocardial Ischemia, Acute Coronary Syndrome

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
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
Sponsored by
Ceric Sàrl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,
  • 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

Sites / Locations

  • CHU St Pierre
  • Centre Hospitalier de Jolimont
  • UZ Leuven
  • CHU de Liège - Domaine Universitaire du Sart Tilman
  • Oulu University Hospital
  • Heary Center - Satakunta Centyral Hospital
  • Hôpital Ambroise Paré
  • Hôpital Henri Mondor
  • Hôpital de la Timone
  • Hôpital Privé Jacques Cartier
  • Polyclinique les Fleurs
  • Hôpital Lariboisière
  • Hôpital La Pitié-Salpêtrière
  • Hôpital Cochin
  • Hôpital Européen Georges Pompidou
  • Hôpital Privé Claude Galien
  • CHU Toulouse Rangueil
  • ARNAS civico
  • Pauls Stradins Clinical University Hospital
  • University Clinic of Cardiology - Medical Faculty
  • Hospital universitario Marquès de Valdecilla
  • Hospital San Juan de Alicante
  • Complexo Hospitalario Universitario A Coruña
  • Hospital Universati Germans Trias i Pujol
  • Hospital del Mar
  • Hospital Clinic
  • Hospital de la Santa Creu i Sant pau
  • Hospital Juan Roamon Jimenez
  • Hospital Universitario virgen de la arrixaca
  • Hospital Universitario de Salamanca
  • Hospital virgen de la salud.
  • Hospital Clinico Universitario de Valladolid
  • Hospital Meixoiero
  • Hôpital Fribourgeois
  • Centre hospitalier universitaire vaudois
  • Luzerner Kantonsspital
  • Kantonsspital St. Gallen
  • Kantonsspital Winterthur
  • Brighton and Sussex Hospitals
  • Craigavon Cardiac Center
  • Guy's and St.Thomas'Hospitals
  • King's College London
  • Freeman Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug Eluting Stent

Bare Metal Stent

Arm Description

Synergy II

Omega or Rebel

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 24, 2014
Last Updated
May 1, 2017
Sponsor
Ceric Sàrl
Collaborators
Boston Scientific; Pr Olivier Varenne
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1. Study Identification

Unique Protocol Identification Number
NCT02099617
Brief Title
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.
Acronym
SENIOR
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (Actual)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ceric Sàrl
Collaborators
Boston Scientific; Pr Olivier Varenne

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina, Silent Myocardial Ischemia, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug Eluting Stent
Arm Type
Experimental
Arm Description
Synergy II
Arm Title
Bare Metal Stent
Arm Type
Active Comparator
Arm Description
Omega or Rebel
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent
Primary Outcome Measure Information:
Title
Composite measure of MACCEs (Major Adverse Cardiac and Cerebrovascular Events)
Description
all-cause death, non fatal myocardial infarction, non fatal stroke, ischemia-driven target lesion revascularization.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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, 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
Facility Information:
Facility Name
CHU St Pierre
City
Brussels
ZIP/Postal Code
1150
Country
Belgium
Facility Name
Centre Hospitalier de Jolimont
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liège - Domaine Universitaire du Sart Tilman
City
Liège 1
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Heary Center - Satakunta Centyral Hospital
City
Pori
Country
Finland
Facility Name
Hôpital Ambroise Paré
City
Boulogne-Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hôpital Privé Jacques Cartier
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
Polyclinique les Fleurs
City
Ollioules
ZIP/Postal Code
83 190
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital La Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Privé Claude Galien
City
Quincy sous Sénart
ZIP/Postal Code
91480
Country
France
Facility Name
CHU Toulouse Rangueil
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
ARNAS civico
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
University Clinic of Cardiology - Medical Faculty
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Hospital universitario Marquès de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital San Juan de Alicante
City
Alicante
State/Province
Valencia
Country
Spain
Facility Name
Complexo Hospitalario Universitario A Coruña
City
A Coruna
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universati Germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant pau
City
Barcelona
Country
Spain
Facility Name
Hospital Juan Roamon Jimenez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Hospital Universitario virgen de la arrixaca
City
Murcia
ZIP/Postal Code
30107
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital virgen de la salud.
City
Toledo
ZIP/Postal Code
45071
Country
Spain
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
Facility Name
Hospital Meixoiero
City
Vigo
ZIP/Postal Code
36200
Country
Spain
Facility Name
Hôpital Fribourgeois
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
Centre hospitalier universitaire vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Luzerner Kantonsspital
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St.Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
Country
Switzerland
Facility Name
Brighton and Sussex Hospitals
City
Brighton
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
Craigavon Cardiac Center
City
Craigavon
ZIP/Postal Code
BT62 5QQ
Country
United Kingdom
Facility Name
Guy's and St.Thomas'Hospitals
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 9PJ
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29102362
Citation
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.
Results Reference
derived

Learn more about this trial

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.

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