## Protocol Section
### Identification Module
**NCT ID:** NCT00500279

**Acronym:** mini-COREA

**Brief Title:** Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial

#### Organization Study ID Info
**ID:** H-0611-011-188
#### Organization
**Class:** OTHER
**Full Name:** Seoul National University Hospital
### Status Module
#### Completion Date
**Date:** 2009-10

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2007-07-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2007-07-10

**Overall Status:** UNKNOWN

#### Start Date
**Date:** 2006-11

**Status Verified Date:** 2007-07

#### Study First Post Date
**Date:** 2007-07-12
**Type:** ESTIMATED
**Study First Submit Date:** 2007-07-10
**Study First Submit QC Date:** 2007-07-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Seoul National University Hospital

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To evaluate the effect of celecoxib use for 3 month after drug-eluting stent implantation

* on restenosis
* on clinical outcome such as target lesion revascularization, thrombotic event, myocardial infarction, death
* on inflammatory biomarkers

**Detailed Description:** Restenosis is the major adverse effect of coronary stent implantation. Drug-eluting stent has markedly reduced restenosis as compared with bare-metal stent, but restenosis is still the main cause of repeat coronary intervention after drug-eluting stent implantation. After coronary stent implantation, inflammatory reaction occurs in vessel wall and vascular smooth muscle cells proliferate. Celecoxib is well known to have anti-proliferative effect as well as anti-inflammatory effect, and safety of this drug is well-established. Celecoxib use for 6 month after paclitaxel-eluting stent implantation significantly reduced neointimal growth and repeat intervention without increase in adverse effect. Because inflammatory reaction seems to occur in very early period after vessel injury, reduced use of celecoxib may also be effective.

### Conditions Module

**Conditions:**

- Angioplasty, Transluminal, Percutaneous Coronary

- Coronary Restenosis

**Keywords:**

- Drug-eluting stent

- Restenosis

- Celecoxib

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 900

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Celecoxib

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** late luminal loss on quantitative coronary angiography

**Time Frame:** six month

#### Secondary Outcomes

**Measure:** target lesion revascularization, myocardial infarction, death, thrombotic events

**Time Frame:** six and eighteen month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* angina pectoris or a positive stress test with native coronary artery lesions feasible for drug-eluting stent implantation

Exclusion Criteria:

* acute or recent ST segment elevation myocardial infarction (within four weeks)
* left main coronary artery disease
* hepatic dysfunction (AST or ALT \> 120 IU/L )
* renal dysfunction (serum creatinine \> 2.0 mg/dl)
* severe congestive heart failure (NYHA class \> 2)
* left ventricular ejection fraction \< 30%
* hemodynamically unstable condition
* definite intracoronary thrombus
* contraindication or history of allergy to aspirin, clopidogrel, or celecoxib
* warfarin use
* expected survival less than two years due to other medical conditions
* patients already taking any COX-3 inhibitor or NASIDS

**Maximum Age:** 75 Years

**Minimum Age:** 30 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hyosoo@snu.ac.kr

**Name:** Hyosoo Kim, MD, PhD

**Phone:** 82-2-2072-2226

**Role:** CONTACT

**Contact 2:**

**Email:** jjw25@medimail.co.kr

**Name:** Jinwook Chung, MD

**Phone:** 80-2-2072-3757

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seongnam

**Country:** Korea, Republic of

**Facility:** Seoul National University Bundang Hospital

**Status:** RECRUITING

**Zip:** 463-707

**Location 2:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Seuoul National University Hospital

**Status:** RECRUITING

**Zip:** 110-744

#### Overall Officials

**Official 1:**

**Affiliation:** Seoul National University Hospital

**Name:** Hyosoo Kim, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Seoul National University Hospital

**Name:** Bonkwon Koo, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Yang HM, Kim HS, Park KW, You HJ, Jeon SI, Youn SW, Kim SH, Oh BH, Lee MM, Park YB, Walsh K. Celecoxib, a cyclooxygenase-2 inhibitor, reduces neointimal hyperplasia through inhibition of Akt signaling. Circulation. 2004 Jul 20;110(3):301-8. doi: 10.1161/01.CIR.0000135467.43430.16. Epub 2004 Jul 6.

**PMID:** 15238462

**Citation:** Wang K, Tarakji K, Zhou Z, Zhang M, Forudi F, Zhou X, Koki AT, Smith ME, Keller BT, Topol EJ, Lincoff AM, Penn MS. Celecoxib, a selective cyclooxygenase-2 inhibitor, decreases monocyte chemoattractant protein-1 expression and neointimal hyperplasia in the rabbit atherosclerotic balloon injury model. J Cardiovasc Pharmacol. 2005 Jan;45(1):61-7. doi: 10.1097/00005344-200501000-00011.

**PMID:** 15613981

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000023921

- Term: Coronary Stenosis

- ID: D000003327

- Term: Coronary Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular 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: M26188

- Name: Atherosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M22912

- Name: Coronary Restenosis

- Relevance: HIGH

- As Found: Coronary Restenosis

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M22913

- Name: Coronary Stenosis

- Relevance: LOW

- As Found: Unknown

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000023903

- Term: Coronary Restenosis

### 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: D000052246

- Term: Cyclooxygenase 2 Inhibitors

- ID: D000016861

- Term: Cyclooxygenase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M277

- Name: Celecoxib

- Relevance: HIGH

- As Found: Air

- 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: M27009

- Name: Cyclooxygenase 2 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

### Intervention Browse Module - Meshes

- ID: D000068579

- Term: Celecoxib

### Misc Info Module

- Version Holder: 2024-05-24
