Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT00343395
Eligibility Criteria:
Inclusion Criteria:
* The patient (male or non-pregnant female) must be \> 18 years of age.
* The patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board.
* Angiographically documented coronary artery disease defined as the presence of at least one 50% or greater stenosis of a major coronary artery.
* Stabilized post any prior ACS event (i.e., without ongoing ischemic rest pain, congestive heart failure, or malignant arrhythmias) for at least 3 months
* Fasting blood glucose 87-125 mg/dL
Exclusion Criteria:
* Age \<18 years
* Known hypersensitivity to metformin or rosiglitazone
* Renal insufficiency defined as calculated creatinine clearance (CrCl) \<40 mL/min using the following formula:
Men: CrCL (mL/min) = Weight (kg) x (140-age) 72 x serum creatinine (mg/dL) Women: 0.85 x the value calculated for men
* Pregnant and/or lactating women, and women of child bearing potential are excluded from this trial
* Co-morbidity such that the patient is not expected to survive \>2 years
* Current therapy with rosiglitazone or metformin
* PCI within the previous six months (other than for the qualifying event)
* Prior CABG within the previous two months, scheduled CABG, or a decision to perform CABG made prior to enrollment
* Overt diabetes mellitus (FBG\>126 or antidiabetic therapy)
* Any diagnosis of congestive heart failure
* Obstructive hepatobiliary disease or other significant hepatic disease (defined as the presence of at least one of the following: AST, ALT, GGT, total bilirubin, or alkaline phosphatase \>3x upper limit normal, not related to MI
* Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00343395
Study Brief:
Protocol Section:
NCT00343395