Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465296
Status:
TERMINATED
Last Update Posted:
2008-05-22
First Post:
2007-04-23
Brief Title:
Ppar-Gamma EliminAtes Restenosis Longevity Study PEARLS
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Ppar-Gamma EliminAtes Restenosis Longevity Study PEARLS
Status:
TERMINATED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding Discontinued
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this clinical trial is to assess the efficacy of rosiglitazone on bare metal stent BMS in-stent restenosis measured as late lumen loss in patients with metabolic syndrome
The secondary parameter for evaluation of efficacy is binary restenosis
The tertiary objective will be to assess the effect of rosiglitazone on major cardiac events MACE death MI CABG and target vessel revascularization The occurrence of in-stent restenosis for patients with metabolic syndrome who receive a DES in a non-target lesion will be assessed angiographically at 9 months
The secondary parameter for evaluation of efficacy is binary restenosis
The tertiary objective will be to assess the effect of rosiglitazone on major cardiac events MACE death MI CABG and target vessel revascularization The occurrence of in-stent restenosis for patients with metabolic syndrome who receive a DES in a non-target lesion will be assessed angiographically at 9 months
Detailed Description:
This is a prospective multicenter double blind randomized clinical trial of patients who present to the catheterization laboratory for PCI elective or setting of ACS and receive at least one bare metal stent
Patients will be randomized on a 11 basis to receive either rosiglitazone or placebo for 9 months Patients will be followed for 9 months post procedure All patients will be required to have a repeat angiogram with optional IVUS analysis at 9 months
Patients will be randomized on a 11 basis to receive either rosiglitazone or placebo for 9 months Patients will be followed for 9 months post procedure All patients will be required to have a repeat angiogram with optional IVUS analysis at 9 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None