Trial Outcomes & Findings for Effect of Pioglitazone on Insulin Resistance, Atherosclerosis Progression and Clinical Course of Coronary Heart Disease (NCT NCT03011775)
NCT ID: NCT03011775
Last Updated: 2022-03-10
Results Overview
Number of Participants with cardiovascular death
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
Baseline and 1 year
Results posted on
2022-03-10
Participant Flow
Participant milestones
| Measure |
Pioglitazone + Standard Care
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
23
|
|
Overall Study
COMPLETED
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Pioglitazone on Insulin Resistance, Atherosclerosis Progression and Clinical Course of Coronary Heart Disease
Baseline characteristics by cohort
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 1.15 • n=5 Participants
|
53 years
STANDARD_DEVIATION 1.36 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 yearNumber of Participants with cardiovascular death
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Сardiovascular Death
Baseline
|
0 Participants
|
0 Participants
|
|
Сardiovascular Death
1 year
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 yearNumber of Participants with revascularization coronary procedures (coronary artery bypass grafting)
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Coronary Artery Bypass [Coronary Revascularization]
Baseline
|
0 Participants
|
0 Participants
|
|
Coronary Artery Bypass [Coronary Revascularization]
1 year
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 yearNumber of Participants with acute coronary syndrome (ACS) or unstable angina (UA)
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Cardiovascular Hospitalization
Baseline
|
0 Participants
|
0 Participants
|
|
Cardiovascular Hospitalization
1 year
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 yearNumber of Participants with incidence of percutaneous coronary intervention.
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Percutaneous Coronary Intervention [Coronary Revascularization]
Baseline
|
0 Participants
|
0 Participants
|
|
Percutaneous Coronary Intervention [Coronary Revascularization]
1 year
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 month and 1 yearLiver injury: mean values of ALT
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Safety and Tolerability 1
Baseline
|
23.4 units per liter (U/L)
Standard Deviation 2.4
|
26.9 units per liter (U/L)
Standard Deviation 2.57
|
|
Safety and Tolerability 1
Mean values of ALT in 6 months
|
27.4 units per liter (U/L)
Standard Deviation 2.1
|
26.1 units per liter (U/L)
Standard Deviation 1.68
|
|
Safety and Tolerability 1
Mean values of ALT in 1 year
|
19.9 units per liter (U/L)
Standard Deviation 1.9
|
23.9 units per liter (U/L)
Standard Deviation 1.19
|
PRIMARY outcome
Timeframe: Baseline, 6 month and 1 yearLiver injury: mean levels of total bilirubin
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Safety and Tolerability 2
Baseline
|
12.3 μmol/l
Standard Deviation 1.3
|
10.8 μmol/l
Standard Deviation 1.01
|
|
Safety and Tolerability 2
Mean values of total bilirubin in 6 month
|
12.4 μmol/l
Standard Deviation 1.02
|
12.7 μmol/l
Standard Deviation 1.05
|
|
Safety and Tolerability 2
Mean values of total bilirubin in 1 year
|
15.7 μmol/l
Standard Deviation 1.6
|
15.0 μmol/l
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: Baseline and 1 yearKidney injury: mean values of the microalbuminuria
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Safety and Tolerability 3
Baseline
|
31.44 mg/mol
Standard Deviation 4.28
|
41.1 mg/mol
Standard Deviation 4.85
|
|
Safety and Tolerability 3
1 year
|
31.10 mg/mol
Standard Deviation 5.00
|
37.70 mg/mol
Standard Deviation 4.48
|
PRIMARY outcome
Timeframe: Baseline and 1 yearKidneys injury: mean values of creatinine
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Safety and Tolerability 4
Mean values of creatinine in men baseline
|
105.6 μmol/l
Standard Deviation 38.5
|
102.3 μmol/l
Standard Deviation 43.1
|
|
Safety and Tolerability 4
Mean values of creatinine in men in 1 year
|
85.0 μmol/l
Standard Deviation 21.1
|
82.0 μmol/l
Standard Deviation 14.0
|
|
Safety and Tolerability 4
Mean values of creatinine in women baseline
|
66.8 μmol/l
Standard Deviation 8.8
|
88.2 μmol/l
Standard Deviation 11.1
|
|
Safety and Tolerability 4
Mean values of creatinine in women in 1 year
|
72.5 μmol/l
Standard Deviation 8.1
|
77.5 μmol/l
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: Baseline, 6 month and 1 yearMean thickness of carotid intima-media complex
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Thickness of the Intima-media Complex
Mean thickness of the left carotid intima-media in 1 year
|
1.02 cm
Standard Deviation 0.02
|
0.97 cm
Standard Deviation 0.02
|
|
Thickness of the Intima-media Complex
Mean thickness of the right carotid intima-media baseline
|
1.08 cm
Standard Deviation 0.17
|
0.98 cm
Standard Deviation 0.15
|
|
Thickness of the Intima-media Complex
Mean thickness of the right carotid intima-media in 6 month
|
1.05 cm
Standard Deviation 0.13
|
0.97 cm
Standard Deviation 0.11
|
|
Thickness of the Intima-media Complex
Mean thickness of the right carotid intima-media in 1 year
|
1.01 cm
Standard Deviation 0.02
|
1.01 cm
Standard Deviation 0.01
|
|
Thickness of the Intima-media Complex
Mean thickness of the left carotid intima-media baseline
|
1.1 cm
Standard Deviation 0.18
|
1.0 cm
Standard Deviation 0.15
|
|
Thickness of the Intima-media Complex
Mean thickness of the left carotid intima-media in 6 month
|
1.06 cm
Standard Deviation 0.13
|
1.00 cm
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Baseline and 1 yearMean diameters of the stenosis of the right and left common carotid arteries
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Diameter of Stenosis [Carotic Atherosclerotic Lesions]
Mean diameter of the stenosis of the right common carotid artery baseline
|
9.8 mm
Standard Deviation 3.1
|
8.7 mm
Standard Deviation 2.7
|
|
Diameter of Stenosis [Carotic Atherosclerotic Lesions]
Mean diameter of the stenosis of the right common carotid artery in 1 year
|
5.0 mm
Standard Deviation 1.8
|
4.8 mm
Standard Deviation 1.5
|
|
Diameter of Stenosis [Carotic Atherosclerotic Lesions]
Mean diameter of the stenosis of the left common carotid artery baseline
|
11.6 mm
Standard Deviation 3.6
|
10.1 mm
Standard Deviation 3.0
|
|
Diameter of Stenosis [Carotic Atherosclerotic Lesions]
Mean diameter of the stenosis of the left common carotid artery in 1 year
|
4.1 mm
Standard Deviation 1.7
|
5.6 mm
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline and 1 yearNumber of Participants with presence of atherosclerotic plaque of the intima media of common carotid artery greater than 1.4 mm
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Carotic Atherosclerotic Lesions
Baseline
|
0 Participants
|
0 Participants
|
|
Carotic Atherosclerotic Lesions
1 year
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 1 yearNumber of Participants with C-reactive protein level above 3 mg/L
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Systemic Inflammation Level
Baseline
|
10 Participants
|
7 Participants
|
|
Systemic Inflammation Level
In 1 year
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 month and 1 yearMean levels of total serum cholesterol
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Lipid Metabolism 1
Mean values of the total cholesterol level baseline
|
5.27 mmol / l
Standard Deviation 0.2
|
5.28 mmol / l
Standard Deviation 1.0
|
|
Lipid Metabolism 1
Mean values of the total cholesterol level in 6 month
|
4.5 mmol / l
Standard Deviation 0.2
|
4.3 mmol / l
Standard Deviation 0.2
|
|
Lipid Metabolism 1
Mean values of the total cholesterol level in 1 year
|
4.5 mmol / l
Standard Deviation 0.2
|
4.3 mmol / l
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline, 6 month and 1 yearMean values of the triglyceride levels
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Lipid Metabolism 2
Mean values of triglyceride baseline
|
0.69 1 mmol/L
Standard Deviation 0.1
|
0.61 1 mmol/L
Standard Deviation 0.21
|
|
Lipid Metabolism 2
Mean values of triglyceride in 6 month
|
0.72 1 mmol/L
Standard Deviation 0.40
|
0.73 1 mmol/L
Standard Deviation 0.25
|
|
Lipid Metabolism 2
Mean values of triglyceride in 1 year
|
0.9 1 mmol/L
Standard Deviation 0.1
|
0.7 1 mmol/L
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Baseline and 1 yearLipoproteine fractions:mean values of high-density lipoproteins and low density lipoproteins
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Lipid Metabolism 3
Mean values of high-density lipoproteins in men in 1 year
|
1.1 mmol/L
Standard Deviation 0.3
|
1.0 mmol/L
Standard Deviation 0.3
|
|
Lipid Metabolism 3
Mean values of high-density lipoproteins in women baseline
|
0.9 mmol/L
Standard Deviation 0.3
|
1.1 mmol/L
Standard Deviation 0.2
|
|
Lipid Metabolism 3
Mean values of high-density lipoproteins in women in 1 year
|
1.2 mmol/L
Standard Deviation 0.2
|
1.0 mmol/L
Standard Deviation 0.2
|
|
Lipid Metabolism 3
Mean values of low density lipoproteins in men baseline
|
3.9 mmol/L
Standard Deviation 0.7
|
4.4 mmol/L
Standard Deviation 0.8
|
|
Lipid Metabolism 3
Mean values of low density lipoproteins in men in 1 year
|
2.9 mmol/L
Standard Deviation 0.5
|
3.0 mmol/L
Standard Deviation 0.6
|
|
Lipid Metabolism 3
Mean values of low density lipoproteins in women baseline
|
4.5 mmol/L
Standard Deviation 0.8
|
3.5 mmol/L
Standard Deviation 0.8
|
|
Lipid Metabolism 3
Mean values of low density lipoproteins in women in 1 year
|
3.3 mmol/L
Standard Deviation 0.8
|
2.7 mmol/L
Standard Deviation 0.3
|
|
Lipid Metabolism 3
Mean values of high-density lipoproteins in men baseline
|
0.8 mmol/L
Standard Deviation 0.2
|
0.9 mmol/L
Standard Deviation 0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsOral glucose tolerance test: number of Participants with impaired glucose tolerance
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Level of Insulin Resistance 1
Number of Participants with glucose level in the range of 7.8 to 11 mmol/L baseline
|
7 Participants
|
14 Participants
|
|
Level of Insulin Resistance 1
Number of Participants with glucose level in the range of 7.8 to 11 mmol/L in 6 month
|
13 Participants
|
16 Participants
|
|
Level of Insulin Resistance 1
Number of Participants with glucose level above 11 mmol/L baseline
|
10 Participants
|
4 Participants
|
|
Level of Insulin Resistance 1
Number of Participants with glucose level above 11 mmol/L in 6 month
|
5 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 monthsMean levels of blood glucose
Outcome measures
| Measure |
Pioglitazone + Standard Care
n=20 Participants
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.
Pioglitazone 15 mg Tablet: 1 tablet per day in the morning for 6 months
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
Standard Care
n=23 Participants
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.
Isosorbide Dinitrate 10Mg Tablet: 1-2 tablets 2 times a day
Acetylsalicylic Acid 75Mg Tablet: 1 tablet per a day
Bisoprolol Fumarate 2.5 MG Oral Tablet: 1 tablet per a day
Rosuvastatin Calcium 20 MG Oral Tablet: 1 tablet per a day
ramipril 5 MG: 1 tablet per a day
|
|---|---|---|
|
Level of Insulin Resistance 2
Baseline
|
6.0 mmol/L
Standard Deviation 0.1
|
5.9 mmol/L
Standard Deviation 0.54
|
|
Level of Insulin Resistance 2
In 6 month
|
5.97 mmol/L
Standard Deviation 0.20
|
5.60 mmol/L
Standard Deviation 0.79
|
Adverse Events
Pioglitazone + Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Igor Kaidashev
Ukrainian Medical Stomatological Academy
Phone: +380505858953
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place