Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS|
- The primary objective 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 is to assess the effect of rosiglitazone on major cardiac events and target vessel revascularization).
|Study Start Date:||January 2006|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
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.
|United States, District of Columbia|
|Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Ron Waksman, MD||Washington Hospital Center|