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Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS

This study has been terminated.
(Funding Discontinued)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT00465296
First received: April 23, 2007
Last updated: May 21, 2008
Last verified: April 2007
History of Changes
  Purpose

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 Intervention Phase
Metabolic Syndrome
 Drug: rosiglitazone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 200
Study Start Date: January 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient's age >/=18 years;

  • Patients must meet MS definition, which means that each patient must meet at least 3 of listed requirements of MS:

    • A waist circumference of 40 inches or more for men and 35 inches or more for women (measured across the belly);
    • A blood pressure of 130/85 mm Hg or higher;
    • A triglyceride level 150 mg/dl or above;
    • A fasting blood glucose level greater than 110 mg/dl , but less than 126; and/or
    • A high density lipoprotein level (HDL) less than 40 mg/dl (men) or under 50 mg/dl (women).
  • Patients eligible for PCI;
  • Patients must receive at least one bare metal stent;
  • The patient has stable or unstable angina with clinical evidence of ischemia (ECG, exercise test, etc.); and/or
  • The patient is able and willing to conform to the requirements of the study including repeat angiographic follow-up at 9 months, and voluntarily signs an Informed Consent.

Exclusion Criteria:

  • • Patient has experienced an ST-segment elevation myocardial infarction within the preceding 48 hours; Patient must have CPK and CK-MB <3 times upper limit of normal at the time of angioplasty and enrollment;

    • Previously diagnosed with either type 1 or type 2 diabetes and controlling glucose by one or a combination of the following treatments: diet, oral anti-diabetic agents, or insulin;
    • Patient had or plans to have CABG within 9 months;
    • Ejection fraction <35%; class III-IV CHF;
    • Active liver disease (ALT >2.5 times upper limit of normal);
    • Women who are pregnant;
    • A platelet count of less than 100,000 cells/mm3;
    • Impaired renal function (creatinine ≥2.5 mg/dL) or status post renal transplant;
    • Recipient of heart transplant;
    • Patient with a life expectancy less than 12 months;
    • Known allergies to aspirin, clopidogrel bisulfate (PlavixR) and ticlopidine (TiclidR), heparin, bivalirudin, contrast, or pioglitazone, that cannot be medically managed;
    • Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study;
    • Currently participating in an investigational drug or another device study;
    • Current use of any thiazolidinedione (Rosiglitazone (Avandia) or Poiglitazone (Actos).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465296

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Research Institute
GlaxoSmithKline
Investigators
Principal Investigator: Ron Waksman, MD Washington Hospital Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00465296     History of Changes
Other Study ID Numbers: PEARLS
Study First Received: April 23, 2007
Last Updated: May 21, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013