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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Hôpital Ambroise Paré
      • Créteil, France, 94000
        • Hopital Henri Mondor
      • Marseille, France, 13005
        • Hôpital de la Timone
      • Massy, France, 91300
        • Hôpital Privé Jacques Cartier
      • Ollioules, France, 83 190
        • Polyclinique Les Fleurs
      • Paris, France, 75015
        • Hôpital Europeén 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 Clinic
      • 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 Marqués 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ceric Sàrl

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2014

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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