Male or female non-diabetic patients at an age between 30 and 79 years (inclusive) with a proven vascular disease defined as arteriosclerosis confirmed by presence of CAD, PAD or carotid plaques.
Conditions
Interventions
Trade Name: Actos 45 mg
Product Name: Pioglitazon
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Actos 30 mg
Produ
Sponsors
University Hospital of Ulm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patient at an age between 30 and 79 years (inclusive); the patient has a proven vascular disease defined as arteriosclerosis confirmed by the presence of CAD or PAD or carotid plaques; normal HbA1c (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Hemodynamic unstable patient or unstable acute coronary syndrome or state after acute myocardial infarction = 4 days; History of diabetes mellitus (any type 1 or 2); History of heart failure (NYHA I-IV) or relevant respiratory, renal (creatinine > 2.0 mg/dl), gastrointestinal or hematological diseases; History of renal failure requiring hemodialysis; Inadequate hepatic function (AST and ALT > 2.5 x ULN) ; History of severe/multiple allergies or systemic inflammatory diseases; History of any cancer disease or any cancer treatment in the last 5 years (exception: non-metastasizing skin cancer); Known/suspected hypersensitivity to pioglitazone or other TZDs; Pre- treatment with TZDs during 3 months prior to study enrolment; Severe claustro-phobia and/or MR-incompatible implants, and/or large sized coloured tattoos; Drug/alcohol abuse in the last 5 years; Blood donation in the last 30 days; Pregnant or nursing woman, or woman of childbearing potential not using effective contraceptive methods during the study (medications, patches, condoms, IUDs, male partner sterilization); Any further condition which according to the investigator results in an undue risk to the patient during participating in the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Exploration of possible differences in the effect on IMT (as the total vessel wall volume in MRI) of an add-on-therapy with pioglitazone versus placebo in non-diabetic patients with confirmed arteriosclerosis in order to gain more detailed information and to generate valid hypotheses for further project planning.;Secondary Objective: Evaluation of relevant further efficacy, safety and tolerability parameters considering IMT-measurements, MR-angiography (patient subgroup), laboratory variables, vital signs and adverse events in non-diabetic patients with confirmed arteriosclerosis under add-on-therapy with pioglitazone compared to placebo. In a selected subgroup of study patients defined as patients with proven significant (>50% stenosis) proximal coronary artery disease without ischemia (no invasive treatment with PTCA or stenting), a visualization of the coronary vessel status (MRI assessment of the vessel lumen and the vessel wall thickness) will be performed additionally by specific MR-angiography.;Primary end point(s): Analysis of the total vessel wall volume of the carotid bulbus/bifurcation (CB) determined with MRI after 24 months of study treatment compared to baseline (Visit 2; Day 1) | — |
Countries
Germany
Outcome results
None listed