Effects of Celecoxib After Percutaneous Coronary Intervention

Coronary Arteriosclerosis Clinical Trial

Official title:

Effects of Celecoxib on Restenosis After Percutaneous Coronary Intervention and Evolution of Atherosclerosis (COREA) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292721
• Other study ID #: 134-?-37
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2006
• Last updated: July 20, 2011
• Start date: August 2004
• Est. completion date: October 2008

Study information

• Verified date: July 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Several studies including ours have reported that celecoxib improves endothelium-dependent vasodilation and reduces inflammation and neointimal hyperplasia. Our hypothesis is that celecoxib may reduce the late luminal loss after coronary stent implantation (paclitaxel-eluting stent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Coronary artery disease with at least 1 de novo lesion greater than 50% stenosis on coronary angiography

Exclusion Criteria:

• Acute ST elevation MI

• Left main disease

• Contraindications to aspirin, clopidogrel or celecoxib

• Severe congestive heart failure

• Expected survival < 2 years

• Hepatic dysfunction

• Currently taking NSAIDs or any COX-2 inhibitor

• Renal dysfunction

• Use of warfarin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Drug:
• Celecoxib
celecoxib: loading and maintenance for 6 months

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late luminal loss at 6 months		6 months	No