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.

• Register: ClinicalTrials.gov
• Last refreshed on: 22 January 2024
• Main ID: NCT02099617
• Date of registration: 24/03/2014
• Prospective Registration: Yes
• Primary sponsor: Ceric Sàrl
• Public 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. SENIOR
• Scientific 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.
• Date of first enrolment: May 2014
• Target sample size: 1200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02099617
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Belgium, Finland, France, Italy, Latvia, Macedonia, The Former Yugoslav Republic of, North Macedonia, Spain, Switzerland, United Kingdom

Key inclusion & exclusion 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



Age minimum: 75 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Coronary Syndrome

Silent Myocardial Ischemia

Stable Angina

Intervention(s)

Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent

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

Primary Outcome(s)

Composite measure of MACCEs (Major Adverse Cardiac and Cerebrovascular Events) [Time Frame: 12 months]

Secondary Outcome(s)

Cost effectiveness [Time Frame: 12 months]

Stent thombosis [Time Frame: 30 days, 1 year, 2 years]

QoL [Time Frame: 12 months, 24 months]

Primary endpoint [Time Frame: 30 days, 180 days, 2 years]

Major bleedings complications [Time Frame: 30 days, 180 days, 1 year, 2 years]

All revascularizations [Time Frame: 30 days, 180 days, 1 year, 2 years]

Complete revascularization [Time Frame: Baseline procedure]

Depression scale [Time Frame: 12 months, 24 months]

Net benefit [Time Frame: 30 days, 180 daysn 1 year, 2 years]

Secondary ID(s)

10-389

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boston Scientific Corporation