Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent

To compare the clinical outcomes of P2Y12 antagonist monotherapy with aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with bioabsorbable polymer Everolimus-eluting stents (Synergy®)

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: P2Y12 antagonist monotherapy; Drug: Aspirin plus P2Y12 antagonist

• Study Type: Interventional
• Enrollment (Anticipated): 1452
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Souel
    • Seoul, Souel, Korea, Republic of
      • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 19+
2. Patients treated with a new generation of Evelorimus-eluting stents (Synergy®)
3. Patients who understand the content of the subject description and voluntarily sign the subject

Exclusion Criteria:

1. Age 86+
2. Hemodynamically unstable patient
3. Severe hypersensitivity reactions to aspirin, clopidogrel, ticagrelor, everolimus, contrast agent
4. Patients at high risk of bleeding, anemia, thrombocytopenia
5. Patients requiring oral anticoagulants
6. Pregnant women or women of childbearing age
7. Life expectancy is less than one year
8. Patients receiving a potent CYP3A4 inhibitor (eg, ketoconazole, clarithromycin, napjodone, ritonavir, atazanavir)
9. Patients with a history of intracranial hemorrhage
10. Patients with moderate to severe hepatic impairment
11. Patients underwent coronary intervention with stenting within 1 year
12. Patients with left-main lesions requiring coronary intervention
13. Patients with chronic stricture lesions requiring treatment
14. Patients with in-stent restenosis in a lesion requiring treatment
15. Patients with bifurcation lesions requiring stenting in lateral branches
16. Patients with lesions requiring more than 3 stents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: P2Y12 antagonist monotherapy; P2Y12 antagonist monotherapy after 3-month DAPT	Drug: P2Y12 antagonist monotherapy; P2Y12 inhibitor(Clopidogrel 75mg/day or Ticagrelor 180mg/day) for 9months after 3 months of DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day)
Active Comparator: Aspirin + P2Y12 antagonist; Aspirin + P2Y12 antagonist after 3-month DAPT	Drug: Aspirin plus P2Y12 antagonist; DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day) for a year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular clinical events (MACCE)	cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization	between 3 and 12 month after the procedure
Major bleeding	The Bleeding Academic Research Consortium (BARC) type 3 or 5	between 3 and 12 month after the procedure

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Investigators: Principal Investigator: Bumkee Hong, Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): August 17, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 3-2017-0230

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No