Phase 4 N=43 Randomized Prevention

Effect of Pioglitazone on Insulin Resistance, Atherosclerosis Progression and Clinical Course of Coronary Heart Disease

Adverse Effect · Atherosclerosis, Coronary · Insulin Resistance Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT03011775 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2022

Primary outcome: Primary: Сardiovascular Death — 0; 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Pioglitazone 15 mg Tablet (Drug); Isosorbide Dinitrate 10Mg Tablet (Drug); Acetylsalicylic Acid 75Mg Tablet (Drug); Bisoprolol Fumarate 2.5 MG Oral Tablet (Drug); Rosuvastatin Calcium 20 MG Oral Tablet (Drug); Ramipril 5 MG (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Ukrainian Medical Stomatological Academy
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Сardiovascular Death	0; 0; 0; 0	—
PRIMARY Coronary Artery Bypass [Coronary Revascularization]	0; 0; 0; 0	—
PRIMARY Cardiovascular Hospitalization	0; 0; 0; 0	—
PRIMARY Percutaneous Coronary Intervention [Coronary Revascularization]	0; 0; 0; 0	—
PRIMARY Safety and Tolerability 1	23.4; 26.9; 27.4; 26.1; 19.9; 23.9	—
PRIMARY Safety and Tolerability 2	12.3; 10.8; 12.4; 12.7; 15.7; 15.0	—
PRIMARY Safety and Tolerability 3	31.44; 41.1; 31.10; 37.70	—
PRIMARY Safety and Tolerability 4	105.6; 102.3; 85.0; 82.0; 66.8; 88.2	—
SECONDARY Thickness of the Intima-media Complex	1.08; 0.98; 1.05; 0.97; 1.01; 1.01	<0.05 sig
SECONDARY Diameter of Stenosis [Carotic Atherosclerotic Lesions]	9.8; 8.7; 5.0; 4.8; 11.6; 10.1	>0.05
SECONDARY Carotic Atherosclerotic Lesions	0; 0; 0; 0	—
SECONDARY Systemic Inflammation Level	10; 7; 12; 13	>0.05
SECONDARY Lipid Metabolism 1	5.27; 5.28; 4.5; 4.3; 4.5; 4.3	<0.05 sig
SECONDARY Lipid Metabolism 2	0.69; 0.61; 0.72; 0.73; 0.9; 0.7	—
SECONDARY Lipid Metabolism 3	0.8; 0.9; 1.1; 1.0; 0.9; 1.1	<0.05 sig

Summary

Pioglitazone, a medication of thiazolidinedione group, is capable of triggering the peroxisome proliferator-activated receptors (PPAR-γ). Activation of receptor PPAR-γ regulates carbohydrate and lipid metabolism, immune and inflammatory responses in heart tissues. Our aim will to study the effect of pioglitazone on insulin resistance, the clinical course of atherosclerosis and coronary heart disease (CHD). The study will include 43 patients with coronary artery disease. Patients will be divided into the study group - 20 patients, in whom pioglitazone will be included in the combined therapy at a dose of 15 mg 1 time per day in the morning, and the control group - 23 patients receiving standard complex drug therapy over 6 months. Patients will be underwent clinical examination, ultrasound of neck vessels, study of carbohydrate and lipid metabolism. The end primary points of the study will be the onset of death due to myocardial infarction, coronary revascularization procedures (coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI)), or hospitalization for acute coronary syndrome (ACS) or unstable angina (UA). Predefined secondary end points included carotic atherosclerotic leisure (carotic intima-media thickness, diameter of stenosis, presents of atherosclerotic plaque), systemic inflammation level (the level of C reactive protein), lipid metabolism (levels of serum total cholesterol, triglycerides, high and low density lipoproteins), level of insulin resistance ( oral glucose tolerance test, blood glucose).

Eligibility Criteria

Inclusion Criteria

stable exertional angina,
type 2 diabetes mellitus (DM) without receiving injectable antidiabetic drugs

Exclusion Criteria

the presence of myocardial infarction history, intervention;
malignant arterial hypertension (AH);
chronic heart failure (HF) of III-IV functional class (FC);
systemic connective tissue diseases;
cancer and oncohematological diseases, severe infectious diseases, chronic inflammatory diseases;
history of acute cerebrovascular accidents;
disorders of cardiac rhythm by atrial fibrillation type.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03011775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.