Effects of Celecoxib After Percutaneous Coronary Intervention
This study has been completed.
Sponsor:
Seoul National University Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00292721
First received: February 15, 2006
Last updated: July 20, 2011
Last verified: July 2011
| Tracking Information | |||||
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| First Received Date ICMJE | February 15, 2006 | ||||
| Last Updated Date | July 20, 2011 | ||||
| Start Date ICMJE | August 2004 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Late luminal loss at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Late luminal loss at 6 months | ||||
| Change History | Complete list of historical versions of study NCT00292721 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE |
Major adverse cardic events | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Celecoxib After Percutaneous Coronary Intervention | ||||
| Official Title ICMJE | Effects of Celecoxib on Restenosis After Percutaneous Coronary Intervention and Evolution of Atherosclerosis (COREA) Trial | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Coronary Arteriosclerosis | ||||
| Intervention ICMJE | Drug: Celecoxib
celecoxib: loading and maintenance for 6 months |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 260 | ||||
| Completion Date | October 2008 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00292721 | ||||
| Other Study ID Numbers ICMJE | 134-가-37 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Seoul national university hostpial, Seoul National University Hospital | ||||
| Study Sponsor ICMJE | Seoul National University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Seoul National University Hospital | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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