Efficacy of Pioglitazone on Myocardial Function in Patients Undergoing Coronary Stent Implantation.

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effects of pioglitazone, once daily (QD), on heart functioning before, during and after stent implantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• Stable coronary artery disease with planned percutaneous coronary intervention with stent implantation.

• Type II-diabetics and/or an IRIS II score greater than or equal to 50 (measure for the identification of patients with insulin resistance and increased vascular risk).

• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Exclusion Criteria:

• A planned percutaneous coronary intervention with stent implantation less than 15 days after the screening visit.

• Planned multi-vessel intervention.

• Use of systemic corticosteroids within the last 3 months prior to screening visit.

• Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.

• History of severe or multiple allergies.

• Treatment with any other investigational drug within 3 months before trial entry or earlier participation in the present study.

• Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.

• Progressive fatal disease.

• History of drug or alcohol abuse within the last 10 years.

• A history of significant cardiovascular (New York Health Association stage II - IV), respiratory, gastrointestinal, hepatic (alanine aminotransferase greater than 2.5 times the normal reference range), renal (creatinine greater than 1.2 mg/dL in women and greater than 1.5 in men and/or glomerular filtration rate less than 45), neurological, psychiatric and/or hematological disease as judged by the Investigator.

• Pre-treatment with peroxisome proliferator-activated receptor (gamma) agonists within the 3 months prior to screening.

• If insulin therapy applicable: initiation of insulin therapy within the last 3 months.

• If statin therapy applicable: change of medication within the last 4 weeks.

• Myocardial infarction within 3 months prior to screening visit.

• Blood donation within last 30 days.