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Completed

NCT Number: NCT02099617

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.

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.

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Key information

Conditions

Stable Angina Acute Coronary Syndrome Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Silent Myocardial Ischemia Vascular Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU St Pierre, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Primary outcomes

  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.

Secondary outcomes

  1. Primary endpoint

    Time frame: 30 days, 180 days, 2 years

  2. 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

  3. Complete revascularization

    Time frame: Baseline procedure

    anatomic and functional

  4. 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)

  5. Major bleedings complications

    Time frame: 30 days, 180 days, 1 year, 2 years

    type 2, 3 and 5 BARC definition)

  6. Stent thombosis

    Time frame: 30 days, 1 year, 2 years

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

  7. QoL

    Time frame: 12 months, 24 months

  8. Depression scale

    Time frame: 12 months, 24 months

  9. Cost effectiveness

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Ceric Sàrl

Industry

Collaborators

  • Boston Scientific Corporation

Registry information

Acronym: SENIOR

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Mar 31, 2014
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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