Status:
COMPLETED
Efficacy of Pioglitazone on Myocardial Function in Patients Undergoing Coronary Stent Implantation.
Lead Sponsor:
Takeda
Conditions:
Oxidative Stress
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
Type 2 diabetes increases the risk of coronary heart disease at least by two to three fold compared with non-diabetic subjects. Moreover, prospective studies have shown a significant correlation betwe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00771004
Start Date
August 1 2006
End Date
February 1 2009
Last Update
July 5 2010
Active Locations (7)
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1
Hamburg, Hamburg, Germany
2
Frankfurt am Main, Hesse, Germany
3
Kassel, Hesse, Germany
4
Wiesbaden, Hesse, Germany