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)

January 11, 2024 updated by: Ceric Sàrl
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1150
        • Chu St Pierre
      • La Louvière, Belgium, 7100
        • Centre Hospitalier de Jolimont
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège 1, Belgium, 4000
        • CHU de Liège - Domaine Universitaire du Sart Tilman
  • Finland
      • Oulu, Finland, 90220
        • Oulu University Hospital
      • Pori, Finland
        • Heary Center - Satakunta Centyral Hospital
  • France
      • Boulogne-Billancourt, France, 92100
        • Hopital Ambroise Pare
      • Créteil, France, 94000
        • Hôpital Henri Mondor
      • Marseille, France, 13005
        • Hopital de La Timone
      • Massy, France, 91300
        • Hôpital privé Jacques Cartier
      • Ollioules, France, 83 190
        • Polyclinique Les Fleurs
      • Paris, France, 75015
        • Hopital Europeen Georges Pompidou
      • Paris, France, 75010
        • Hôpital Lariboisière
      • Paris, France, 75014
        • Hôpital Cochin
      • Paris, France, 75013
        • Hôpital La Pitié-Salpêtrière
      • Quincy sous Sénart, France, 91480
        • Hôpital Privé Claude Galien
      • Toulouse, France, 31400
        • CHU Toulouse Rangueil
  • Italy
      • Palermo, Italy, 90127
        • ARNAS civico
  • Latvia
      • Riga, Latvia, LV-1002
        • Pauls Stradins Clinical University Hospital
  • North Macedonia
      • Skopje, North Macedonia, 1000
        • University Clinic of Cardiology - Medical Faculty
  • Spain
      • A Coruna, Spain, 08003
        • Complexo Hospitalario Universitario A Coruña
      • Badalona, Spain
        • Hospital Universati Germans Trias i Pujol
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clínic
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Huelva, Spain, 21005
        • Hospital Juan Roamon Jimenez
      • Murcia, Spain, 30107
        • Hospital Universitario Virgen de la Arrixaca
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Toledo, Spain, 45071
        • Hospital virgen de la salud.
      • Valladolid, Spain, 47005
        • Hospital Clínico Universitario de Valladolid
      • Vigo, Spain, 36200
        • Hospital Meixoiero
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • Valencia
      • Alicante, Valencia, Spain
        • Hospital San Juan de Alicante
  • Switzerland
      • Fribourg, Switzerland, 1708
        • Hôpital Fribourgeois
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois
      • Luzern, Switzerland, 6000
        • Luzerner Kantonsspital
      • St.Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen
      • Winterthur, Switzerland
        • Kantonsspital Winterthur
  • United Kingdom
      • Brighton, United Kingdom, BN2 1ES
        • Brighton and Sussex Hospitals
      • Craigavon, United Kingdom, BT62 5QQ
        • Craigavon Cardiac Center
      • London, United Kingdom, SE1 7EH
        • Guy's and St.Thomas'Hospitals
      • London, United Kingdom, SE5 9PJ
        • King's College London
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug Eluting Stent
Synergy II
Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent
Active Comparator: Bare Metal Stent
Omega or Rebel
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite measure of MACCEs (Major Adverse Cardiac and Cerebrovascular Events)
Time Frame: 12 months
all-cause death, non fatal myocardial infarction, non fatal stroke, ischemia-driven target lesion revascularization.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost effectiveness
Time Frame: 12 months
12 months
Primary endpoint
Time Frame: 30 days, 180 days, 2 years
30 days, 180 days, 2 years
All revascularizations
Time Frame: 30 days, 180 days, 1 year, 2 years
All target lesion revascularization, all target vessel revascularization, all non target vessel revascularization
30 days, 180 days, 1 year, 2 years
Complete revascularization
Time Frame: Baseline procedure
anatomic and functional
Baseline procedure
Net benefit
Time Frame: 30 days, 180 daysn 1 year, 2 years
association of composite events (all cause mortality, myocardial infarction, stroke, ischemia driven target lesion revascularization, and major bleedings)
30 days, 180 daysn 1 year, 2 years
Major bleedings complications
Time Frame: 30 days, 180 days, 1 year, 2 years
type 2, 3 and 5 BARC definition)
30 days, 180 days, 1 year, 2 years
Stent thombosis
Time Frame: 30 days, 1 year, 2 years
according to the definition of ARC symptomatic or asymptomatic (definite + probable)
30 days, 1 year, 2 years
QoL
Time Frame: 12 months, 24 months
12 months, 24 months
Depression scale
Time Frame: 12 months, 24 months
12 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ceric Sàrl

Collaborators

Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimated)

March 31, 2014

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-389

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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