CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 43 enrolled
Drug / intervention
Pioglitazone 15 mg Tablet +5 moredrug
Likely dose
Pioglitazone 15 mg orally once daily for 6 monthsAI-extracted
Key inclusion· 2
  • Stable exertional angina
  • Type 2 diabetes mellitus without injectable antidiabetic drugs
Key exclusion· 9
  • History of myocardial infarction or coronary intervention
  • Malignant arterial hypertension
  • Chronic heart failure functional class III-IV
  • Systemic connective tissue diseases

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03011775
NCT03011775Phase 4Completed

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

Ukrainian Medical Stomatological Academy·interventional·Posted Jan 5, 2017·Updated Mar 10, 2022

In Brief

A Phase 4 clinical trial evaluating Pioglitazone 15 mg Tablet, Isosorbide Dinitrate 10Mg Tablet, and 4 other interventions for Adverse Effect and 2 related conditions. Completed, enrolled 43 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUkraine
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 5, 2017
Enrollment StartNov 1, 2012
Primary CompletionJun 1, 2014
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.5 years ago

Interventions

Pioglitazone 15 mg Tabletdrug

Pioglar (Ranbaxy India):1 tablet per day in the morning for 6 months

Isosorbide Dinitrate 10Mg Tabletdrug

1-2 tablets 2 times a day

Acetylsalicylic Acid 75Mg Tabletdrug

1 tablet per a day

Bisoprolol Fumarate 2.5 MG Oral Tabletdrug

1 tablet per a day

Rosuvastatin Calcium 20 MG Oral Tabletdrug

1 tablet per a day

Ramipril 5 MGdrug

1 tablet per a day