Double blind randomized placebo controlled study by virtual histology on the influence of oral pioglitazone for 9 month on the development of coronary plaques in non-diabetic patients with coronary heart disease
- Conditions
- Male or female non-diabetic patients with coronary heart disease with AP or NSTEMI with indication for stent implantation and one additional coronary artery plaque (stenosis < 50%)
- Registration Number
- EUCTR2006-000186-11-DE
- Lead Sponsor
- Med. Klinik / Kardiologie der Med. Fakultät Carl Gustav Carus an der Technischen Unversität Dresden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Instable Angina pectoris or non-ST-elevation myocardial infarction; hemodynamic relevant stenosis >75% of the left coronary artery system; additional stenosis < 50% of the left coronary artery system; age between 18 and 80 years; written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Acute ST-elevation myocardial infarction; diabetes mellitus type I or II; systemic infection; acue or chronic inflammatory disease; sensitivity to Pioglitazone or thiazolidinediones (TZD); severe or multiple allergies; reduction of life expectancy below 12 month; myopathy; heart failure NYHA I to IV; severe organic diseases, cancer, glaucoma, historyof macula oedema, alcohol or drug abuse; pregnancy or brest feeding; blood donor witin last 30 days; previous treatment with TZDs.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of pioglitazone in comparison to placebo on the percental composition of a non-stenosing plaque of a coronary vessel in patients wit coronary artery disease.;Secondary Objective: To investigate the effect of pioglitazone on the<br>- laboratory parameters associated with vessel inflammation and function, <br>- lipd metabolism, and glucose metabolism<br>- intima/media thickness of the arteria carotis communis<br>- neurovascular dialtation reserve and arterio venous ratio of the retinal vessels<br>- safety;Primary end point(s): The primary efficacy variable will be the change of the percentage of the fatty and necrotic parts of the plaque. The change will be calculated as the percentage of the fatty and necrotic parts of the plaque at the baseline visit (Visit 2, day 0) minus procentage of the fatty and necrotic parts of the plaque at the end of the study (Visit 5, week 36 +/- 2).
- Secondary Outcome Measures
Name Time Method