Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_4

Timeline

Completed

Started Nov 2012

Typical duration for phase_4

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

November 1, 2012

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed

1.3 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2016

Completed

7 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed

5.2 years until next milestone

Results Posted

Study results publicly available

March 10, 2022

Completed

Last Updated

March 10, 2022

Status Verified

January 1, 2022

Enrollment Period

1.6 years

First QC Date

December 29, 2016

Results QC Date

October 7, 2021

Last Update Submit

January 9, 2022

Conditions

Adverse Effect Atherosclerosis, Coronary Insulin Resistance Syndrome

Keywords

Pioglitazone, Insulin ResistanceAtherosclerosis, Coronary Heart Disease

Outcome Measures

Primary Outcomes (8)

Сardiovascular Death
Number of Participants with cardiovascular death
Baseline and 1 year
Coronary Artery Bypass [Coronary Revascularization]
Number of Participants with revascularization coronary procedures (coronary artery bypass grafting)
Baseline and 1 year
Cardiovascular Hospitalization
Number of Participants with acute coronary syndrome (ACS) or unstable angina (UA)
Baseline and 1 year
Percutaneous Coronary Intervention [Coronary Revascularization]
Number of Participants with incidence of percutaneous coronary intervention.
Baseline and 1 year
Safety and Tolerability 1
Liver injury: mean values of ALT
Baseline, 6 month and 1 year
Safety and Tolerability 2
Liver injury: mean levels of total bilirubin
Baseline, 6 month and 1 year
Safety and Tolerability 3
Kidney injury: mean values of the microalbuminuria
Baseline and 1 year
Safety and Tolerability 4
Kidneys injury: mean values of creatinine
Baseline and 1 year

Secondary Outcomes (7)

Thickness of the Intima-media Complex
Baseline, 6 month and 1 year
Diameter of Stenosis [Carotic Atherosclerotic Lesions]
Baseline and 1 year
Carotic Atherosclerotic Lesions
Baseline and 1 year
Systemic Inflammation Level
Baseline and 1 year
Lipid Metabolism 1
Baseline, 6 month and 1 year
+2 more secondary outcomes

Other Outcomes (2)

Level of Insulin Resistance 1
6 months
Level of Insulin Resistance 2
Baseline and 6 months

Study Arms (2)

Pioglitazone + Standard Care

EXPERIMENTAL

20 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes. Included pioglitazone 15 mg 1 time per day in the morning for 6 months.

Drug: Pioglitazone 15 mg TabletDrug: Isosorbide Dinitrate 10Mg TabletDrug: Acetylsalicylic Acid 75Mg TabletDrug: Bisoprolol Fumarate 2.5 MG Oral TabletDrug: Rosuvastatin Calcium 20 MG Oral TabletDrug: Ramipril 5 MG

Standard Care

OTHER

23 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes.

Drug: Isosorbide Dinitrate 10Mg TabletDrug: Acetylsalicylic Acid 75Mg TabletDrug: Bisoprolol Fumarate 2.5 MG Oral TabletDrug: Rosuvastatin Calcium 20 MG Oral TabletDrug: Ramipril 5 MG

Interventions

Pioglitazone 15 mg TabletDRUG

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

Also known as: Oral hypoglycemic agent

Pioglitazone + Standard Care

Isosorbide Dinitrate 10Mg TabletDRUG

1-2 tablets 2 times a day

Also known as: Antianginal, vasodilator agent