## Protocol Section
### Identification Module
**NCT ID:** NCT03447379

**Brief Title:** Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent

**Official Title:** Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent

#### Organization Study ID Info
**ID:** 3-2017-0230
#### Organization
**Class:** OTHER
**Full Name:** Gangnam Severance Hospital
### Status Module
#### Completion Date
**Date:** 2022-10-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-09-15

**Type:** ACTUAL

**Last Update Submit Date:** 2022-09-14

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2022-08-17

**Type:** ACTUAL

#### Start Date
**Date:** 2017-12-15

**Type:** ACTUAL

**Status Verified Date:** 2022-09

#### Study First Post Date
**Date:** 2018-02-27
**Type:** ACTUAL
**Study First Submit Date:** 2017-12-01
**Study First Submit QC Date:** 2018-02-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Gangnam Severance Hospital

#### Responsible Party

**Investigator Affiliation:** Gangnam Severance Hospital

**Investigator Full Name:** Bumkee Hong

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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®)

### Conditions Module

**Conditions:**

- Coronary Artery Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1452

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** P2Y12 antagonist monotherapy after 3-month DAPT

**Intervention Names:**

- Drug: P2Y12 antagonist monotherapy

**Label:** P2Y12 antagonist monotherapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Aspirin + P2Y12 antagonist after 3-month DAPT

**Intervention Names:**

- Drug: Aspirin plus P2Y12 antagonist

**Label:** Aspirin + P2Y12 antagonist

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- P2Y12 antagonist monotherapy

**Description:** 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)

**Name:** P2Y12 antagonist monotherapy

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Aspirin + P2Y12 antagonist

**Description:** DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day) for a year

**Name:** Aspirin plus P2Y12 antagonist

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization

**Measure:** Major adverse cardiovascular clinical events (MACCE)

**Time Frame:** between 3 and 12 month after the procedure

**Description:** The Bleeding Academic Research Consortium (BARC) type 3 or 5

**Measure:** Major bleeding

**Time Frame:** between 3 and 12 month after the procedure

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 85 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Gangnam Severance Hospital

**State:** Souel

#### Overall Officials

**Official 1:**

**Affiliation:** Gangnam Severance Hospital

**Name:** Bumkee Hong

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003327

- Term: Coronary Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

### Intervention Browse Module - Ancestors

- ID: D000000894

- Term: Anti-Inflammatory Agents, Non-Steroidal

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000005343

- Term: Fibrinolytic Agents

- ID: D000050299

- Term: Fibrin Modulating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000010975

- Term: Platelet Aggregation Inhibitors

- ID: D000016861

- Term: Cyclooxygenase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000058633

- Term: Antipyretics

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

- Abbrev: Antipy

- Name: Antipyretics

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: FiAg

- Name: Fibrinolytic Agents

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M255

- Name: Everolimus

- Relevance: LOW

- As Found: Unknown

- ID: M1669

- Name: Clopidogrel

- Relevance: LOW

- As Found: Unknown

- ID: M4548

- Name: Aspirin

- Relevance: HIGH

- As Found: Progression

- ID: M1812

- Name: Ticagrelor

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8473

- Name: Fibrinolytic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M13865

- Name: Platelet Aggregation Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19209

- Name: Cyclooxygenase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M29176

- Name: Antipyretics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001241

- Term: Aspirin

### Misc Info Module

- Version Holder: 2024-05-24
