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Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS

Primary Purpose

Metabolic Syndrome

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
rosiglitazone
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Washington Hospital Center

Outcomes

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).

Full Information

First Posted
April 23, 2007
Last Updated
May 21, 2008
Sponsor
Medstar Health Research Institute
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00465296
Brief Title
Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS
Official Title
Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
Funding Discontinued
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medstar Health Research Institute
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rosiglitazone
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The secondary parameter for evaluation of efficacy is binary restenosis.
Title
The tertiary objective is to assess the effect of rosiglitazone on major cardiac events and target vessel revascularization).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Waksman, MD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

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Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS

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