Status:
TERMINATED
Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS
Lead Sponsor:
Medstar Health Research Institute
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. ...
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...
Eligibility Criteria
Inclusion
- 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
- • 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).
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00465296
Start Date
January 1 2006
End Date
July 1 2007
Last Update
May 22 2008
Active Locations (1)
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1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010