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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)

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ClinicalTrials.gov Identifier: NCT02099617
Recruitment Status : Unknown
Verified May 2017 by Ceric Sàrl.
Recruitment status was:  Active, not recruiting
First Posted : March 31, 2014
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Boston Scientific; Pr Olivier Varenne
Information provided by (Responsible Party):
Ceric Sàrl

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stable Angina Silent Myocardial Ischemia Acute Coronary Syndrome Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 2014
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : June 2018

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099617


Locations
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Sponsors and Collaborators
Ceric Sàrl
Boston Scientific; Pr Olivier Varenne
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ceric Sàrl
ClinicalTrials.gov Identifier: NCT02099617    
Other Study ID Numbers: 10-389
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Angina, Stable
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Oxymetazoline
 Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents