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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-000186-11-DE
Enrollment
Unknown
Registered
2006-09-05
Start date
2006-09-22
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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%)

Interventions

Trade Name: Actos 30 mg Product Name: Pioglitazon Pharmaceutical Form: Tablet INN or Proposed INN: Pioglitazone HCl Concentration unit: mg milligram(s) Concentration type: equal Concentration number:

Sponsors

Med. Klinik / Kardiologie der Med. Fakultät Carl Gustav Carus an der Technischen Unversität Dresden
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Instable Angina pectoris or non-ST-elevation myocardial infarction; hemodynamic relevant stenosis >75% of the left coronary artery system; additional stenosis =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 - laboratory parameters associated with vessel inflammation and function, - lipd metabolism, and glucose metabolism - intima/media thickness of the arteria carotis communis - neurovascular dialtation reserve and arterio venous ratio of the retinal vessels - 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).—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026