Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS

Metabolic Syndrome Clinical Trial

Official title:

Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00465296
• Other study ID #: PEARLS
• Status: Terminated
• Phase: Phase 3
• First received: April 23, 2007
• Last updated: May 21, 2008
• Start date: January 2006
• Est. completion date: July 2007

Study information

• Verified date: April 2007
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• rosiglitazone

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Research Institute	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The secondary parameter for evaluation of efficacy is binary restenosis.
Secondary	The tertiary objective is to assess the effect of rosiglitazone on major cardiac events and target vessel revascularization).