NCT00465296

Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 1:1 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.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	rosiglitazone

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2007-04-25
• Last updated: 2008-05-22

Locations

1 site across 1 country: United States