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.

Acute Coronary Syndrome Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099617
• Other study ID #: 10-389
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: June 2018

Study information

• Verified date: May 2017
• Source: Ceric Sàrl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: June 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Stable
• Ischemia
• Myocardial Ischemia
• Silent Myocardial Ischemia
• Stable Angina

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Belgium	CHU St Pierre	Brussels
Belgium	Centre Hospitalier de Jolimont	La Louvière
Belgium	UZ Leuven	Leuven
Belgium	CHU de Liège - Domaine Universitaire du Sart Tilman	Liège 1
Finland	Oulu University Hospital	Oulu
Finland	Heary Center - Satakunta Centyral Hospital	Pori
France	Hôpital Ambroise Paré	Boulogne-Billancourt
France	Hôpital Henri Mondor	Créteil
France	Hôpital de la Timone	Marseille
France	Hôpital Privé Jacques Cartier	Massy
France	Polyclinique les Fleurs	Ollioules
France	Hôpital Cochin	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital La Pitié-Salpêtrière	Paris
France	Hôpital Lariboisière	Paris
France	Hôpital Privé Claude Galien	Quincy sous Sénart
France	CHU Toulouse Rangueil	Toulouse
Italy	ARNAS civico	Palermo
Latvia	Pauls Stradins Clinical University Hospital	Riga
North Macedonia	University Clinic of Cardiology - Medical Faculty	Skopje
Spain	Complexo Hospitalario Universitario A Coruña	A Coruna
Spain	Hospital San Juan de Alicante	Alicante	Valencia
Spain	Hospital Universati Germans Trias i Pujol	Badalona
Spain	Hospital Clinic	Barcelona
Spain	Hospital de la Santa Creu i Sant pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Juan Roamon Jimenez	Huelva
Spain	Hospital Universitario virgen de la arrixaca	Murcia
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital universitario Marquès de Valdecilla	Santander	Cantabria
Spain	Hospital virgen de la salud.	Toledo
Spain	Hospital Clinico Universitario de Valladolid	Valladolid
Spain	Hospital Meixoiero	Vigo
Switzerland	Hôpital Fribourgeois	Fribourg
Switzerland	Centre hospitalier universitaire vaudois	Lausanne
Switzerland	Luzerner Kantonsspital	Luzern
Switzerland	Kantonsspital St. Gallen	St.Gallen
Switzerland	Kantonsspital Winterthur	Winterthur
United Kingdom	Brighton and Sussex Hospitals	Brighton
United Kingdom	Craigavon Cardiac Center	Craigavon
United Kingdom	Guy's and St.Thomas'Hospitals	London
United Kingdom	King's College London	London
United Kingdom	Freeman Hospital	Newcastle upon Tyne
United Kingdom	New Cross Hospital	Wolverhampton

Sponsors (2)

Lead Sponsor	Collaborator
Ceric Sàrl	Boston Scientific Corporation

Countries where clinical trial is conducted

Belgium,  Finland,  France,  Italy,  Latvia,  North Macedonia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Primary endpoint		30 days, 180 days, 2 years
Secondary	All revascularizations	All target lesion revascularization, all target vessel revascularization, all non target vessel revascularization	30 days, 180 days, 1 year, 2 years
Secondary	Complete revascularization	anatomic and functional	Baseline procedure
Secondary	Net benefit	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
Secondary	Major bleedings complications	type 2, 3 and 5 BARC definition)	30 days, 180 days, 1 year, 2 years
Secondary	Stent thombosis	according to the definition of ARC symptomatic or asymptomatic (definite + probable)	30 days, 1 year, 2 years
Secondary	QoL		12 months, 24 months
Secondary	Depression scale		12 months, 24 months
Secondary	Cost effectiveness		12 months