Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS
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|ClinicalTrials.gov Identifier: NCT00465296|
Recruitment Status : Terminated (Funding Discontinued)
First Posted : April 25, 2007
Last Update Posted : May 22, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Drug: rosiglitazone||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465296
|United States, District of Columbia|
|Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Ron Waksman, MD||Medstar Health Research Institute|