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Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS

NCT00465296 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2008-05-22

No results posted yet for this study

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.

Conditions

  • Metabolic Syndrome

Interventions

DRUG

rosiglitazone

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Ron Waksman, MD · Medstar Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00465296 on ClinicalTrials.gov