Trial Outcomes & Findings for CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction (NCT NCT02740699)
NCT ID: NCT02740699
Last Updated: 2024-10-09
Results Overview
Mean change of non-calcified plaque volume assessed by Coronary computed tomography angiography in participants treated with high intensity statin therapy (as defined by the 2013 ACC/AHA Guidelines to Reduce Cardiovascular Risk (GRCR). Using anatomical landmarks, a target plaque volume will be defined at baseline and follow up examinations. Software will be used to trace lumen and outer vessel boundaries to determine non-calcified plaque volume. The 2013 ACC/AHA Guidelines to GRCR focuses on the assessment of cardiovascular risk, lifestyle modifications to reduce cardiovascular risk and management of elevated blood cholesterol and body weight in adults. High-intensity statin therapy is defined by: rosuvastatin 20-40 mg or atorvastatin 40-80 mg. The maximum statin dose will be administered that is tolerated by the patient and that maintains LDL-C \> or = 25 mg/dl. High-intensity statin therapy is defined as lowering LDL-C on average by approximately \> or = 50%.
TERMINATED
PHASE4
79 participants
Baseline and 24 months
2024-10-09
Participant Flow
Participant milestones
| Measure |
Moderate to High Statin Treatment in Participants With Coronary Artery Plaque
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
|
|---|---|
|
Overall Study
STARTED
|
79
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Moderate to High Statin Treatment in Participants With Coronary Artery Plaque
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrawal by Subject
|
14
|
|
Overall Study
Physician Decision
|
5
|
Baseline Characteristics
CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction
Baseline characteristics by cohort
| Measure |
Moderate to High Statin Treatment in Participants With Coronary Artery Plaque
n=79 Participants
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=5 Participants
|
|
Age, Continuous
|
65.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
79 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 monthsPopulation: Intention to treat analysis for those participants with observed plaque volumes by Coronary artery CT angiography at baseline and 24 months will be included in the primary analysis.
Mean change of non-calcified plaque volume assessed by Coronary computed tomography angiography in participants treated with high intensity statin therapy (as defined by the 2013 ACC/AHA Guidelines to Reduce Cardiovascular Risk (GRCR). Using anatomical landmarks, a target plaque volume will be defined at baseline and follow up examinations. Software will be used to trace lumen and outer vessel boundaries to determine non-calcified plaque volume. The 2013 ACC/AHA Guidelines to GRCR focuses on the assessment of cardiovascular risk, lifestyle modifications to reduce cardiovascular risk and management of elevated blood cholesterol and body weight in adults. High-intensity statin therapy is defined by: rosuvastatin 20-40 mg or atorvastatin 40-80 mg. The maximum statin dose will be administered that is tolerated by the patient and that maintains LDL-C \> or = 25 mg/dl. High-intensity statin therapy is defined as lowering LDL-C on average by approximately \> or = 50%.
Outcome measures
| Measure |
Moderate to High Statin Treatment in Participants With Coronary Artery Plaque
n=55 Participants
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
|
|---|---|
|
Mean Change of Non-calcified Plaque Volume in Participants Treated With High Intensity Statin Therapy Assessed by Coronary Computed Tomography Angiography
|
23.3 mm^3
Standard Deviation 76.6
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: Intention to treat for those participants with observed plaque volumes by Coronary artery CT angiography at baseline and 36 months will be included in the secondary analysis.
Mean change of non-calcified plaque volume assessed by Coronary computed tomography angiography in participants treated with high intensity statin therapy (as defined by the 2013 ACC/AHA Guidelines to Reduce Cardiovascular Risk (GRCR). Using anatomical landmarks, a target plaque volume will be defined at baseline and follow up examinations. Software will be used to trace lumen and outer vessel boundaries to determine non-calcified plaque volume. The 2013 ACC/AHA Guidelines to GRCR focuses on the assessment of cardiovascular risk, lifestyle modifications to reduce cardiovascular risk and management of elevated blood cholesterol and body weight in adults. High-intensity statin therapy is defined by: rosuvastatin 20-40 mg or atorvastatin 40-80 mg. The maximum statin dose will be administered that is tolerated by the patient and that maintains LDL-C \> or = 25 mg/dl. High-intensity statin therapy is defined as lowering LDL-C on average by approximately \> or = 50%.
Outcome measures
| Measure |
Moderate to High Statin Treatment in Participants With Coronary Artery Plaque
n=52 Participants
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
|
|---|---|
|
Mean Change of Non-calcified Plaque Volume in Participants Treated With High Intensity Statin Therapy Assessed by Coronary Computed Tomography Angiography
|
8.86 mm^3
Standard Deviation 75.3
|
SECONDARY outcome
Timeframe: Baseline, 24 months and 36 monthsPopulation: Intention to treat for those participants with observed plaque volumes by Coronary artery CT angiography at baseline, 24 months and 36 months will be included in the secondary analysis.
Linear mixed-effects regression coefficient of age effect on plaque volume measured by Coronary artery CT angiography. Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume given one year increase of age. In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware.
Outcome measures
| Measure |
Moderate to High Statin Treatment in Participants With Coronary Artery Plaque
n=52 Participants
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
|
|---|---|
|
Linear Mixed-effects Regression Coefficient of Age Effect on Plaque Volume
|
1.48 mm^3/year
Standard Deviation 2.65
|
SECONDARY outcome
Timeframe: Baseline, 24 months and 36 monthsPopulation: Intention to treat for those participants with observed plaque volumes by Coronary artery CT angiography at baseline, 24 months and 36 months will be included in the secondary analysis.
Linear Mixed-effects Regression Coefficient of sex (female = 0 and male = 1) effect on plaque volume measured by Coronary artery CT angiography (beta coefficient). Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume comparing male verses female (female =0 and male = 1). In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware.
Outcome measures
| Measure |
Moderate to High Statin Treatment in Participants With Coronary Artery Plaque
n=52 Participants
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
|
|---|---|
|
Linear Mixed-Effects Regression Coefficient of Sex Effect on Plaque Volume (Beta Coefficient)
|
100.58 beta coefficient [mm^3]
Standard Deviation 51.99
|
SECONDARY outcome
Timeframe: Baseline, 24 months and 36 monthsPopulation: Intention to treat for those participants with observed plaque volumes by Coronary artery CT angiography at baseline, 24 months and 36 months will be included in the secondary analysis.
Linear Mixed-effects Regression Coefficient of Effects race (white = 1 and non-white = 0) effect on plaque volume measured by Coronary artery CT angiography. Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume comparing race (white = 1 and non-white = 0). In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware.
Outcome measures
| Measure |
Moderate to High Statin Treatment in Participants With Coronary Artery Plaque
n=52 Participants
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
|
|---|---|
|
Linear Mixed-effects Regression Coefficient of Race Effect on Plaque Volume (Beta Coefficient)
|
35.66 Beta coefficient [mm^3]
Standard Deviation 859.39
|
SECONDARY outcome
Timeframe: Baseline, 24 months and 36 monthsPopulation: Intention to treat for those participants with observed plaque volumes by Coronary artery CT angiography at baseline, 24 months and 36 months will be included in the secondary analysis.
Linear Mixed-effects Regression Coefficient of Body Mass Index Effect on Plaque Volume measured by Coronary artery CT angiography. Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume given one kg/m\^2 increase of BMI. In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware.
Outcome measures
| Measure |
Moderate to High Statin Treatment in Participants With Coronary Artery Plaque
n=52 Participants
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
|
|---|---|
|
Linear Mixed-effects Regression Coefficient of Body Mass Index Effect on Plaque Volume
|
7.65 mm^3/[kg/m^2]
Standard Deviation 2.68
|
Adverse Events
Moderate to High Statin Treatment in Participants With Coronary Artery Plaque
Serious adverse events
| Measure |
Moderate to High Statin Treatment in Participants With Coronary Artery Plaque
n=79 participants at risk
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Cardiac disorders
Coronary stent placement
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Nervous system disorders
Dizziness
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Nervous system disorders
Seizure
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Injury, poisoning and procedural complications
Fracture
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Surgical and medical procedures
Knee replacement
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Vascular disorders
Subaraschnoid hemorrhage
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
Other adverse events
| Measure |
Moderate to High Statin Treatment in Participants With Coronary Artery Plaque
n=79 participants at risk
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.9%
7/79 • Number of events 7 • Up to 36 months
|
|
Blood and lymphatic system disorders
Chronic lymphocytic leukemia
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Blood and lymphatic system disorders
Varicosities
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Cardiac disorders
Acute coronary syndrome
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Cardiac disorders
Systolic murmur
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Cardiac disorders
Sick sinus syndrome
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Cardiac disorders
Sinus bradycardia
|
8.9%
7/79 • Number of events 9 • Up to 36 months
|
|
Cardiac disorders
Sinus tachycardia
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Endocrine disorders
Hypothyroidism
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Abdominal infection
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Bloating
|
2.5%
2/79 • Number of events 2 • Up to 36 months
|
|
Gastrointestinal disorders
Diarrhea
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.8%
3/79 • Number of events 3 • Up to 36 months
|
|
Gastrointestinal disorders
Nausea
|
3.8%
3/79 • Number of events 3 • Up to 36 months
|
|
General disorders
Edema limbs
|
5.1%
4/79 • Number of events 4 • Up to 36 months
|
|
General disorders
Fatigue
|
2.5%
2/79 • Number of events 3 • Up to 36 months
|
|
General disorders
Flu like symptoms
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
General disorders
Shoulder pain
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
General disorders
Malaise
|
2.5%
2/79 • Number of events 2 • Up to 36 months
|
|
Infections and infestations
H.pylori
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
Lip infection
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
2/79 • Number of events 2 • Up to 36 months
|
|
Investigations
Alanine aminotransferase increased
|
12.7%
10/79 • Number of events 16 • Up to 36 months
|
|
Investigations
Alkaline phosphatase increased
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Investigations
Aspartate aminotransferase increased
|
13.9%
11/79 • Number of events 14 • Up to 36 months
|
|
Investigations
Blood bilirubin increased
|
3.8%
3/79 • Number of events 5 • Up to 36 months
|
|
Investigations
CPK increased
|
3.8%
3/79 • Number of events 3 • Up to 36 months
|
|
Investigations
Cholesterol high
|
3.8%
3/79 • Number of events 3 • Up to 36 months
|
|
Investigations
Creatinine increased
|
10.1%
8/79 • Number of events 12 • Up to 36 months
|
|
Investigations
Hyperkalemia
|
6.3%
5/79 • Number of events 7 • Up to 36 months
|
|
Investigations
Hypertriglyceridemia
|
10.1%
8/79 • Number of events 14 • Up to 36 months
|
|
Investigations
Hyponatremia
|
6.3%
5/79 • Number of events 7 • Up to 36 months
|
|
Investigations
Hemoglobin A1C increased
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Investigations
LDL decreased
|
7.6%
6/79 • Number of events 7 • Up to 36 months
|
|
Investigations
Lymphocyte count decreased
|
10.1%
8/79 • Number of events 8 • Up to 36 months
|
|
Investigations
Lymphocyte count increased
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Investigations
Platelet count decreased
|
6.3%
5/79 • Number of events 5 • Up to 36 months
|
|
Investigations
Weight gain
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Investigations
Weight loss
|
2.5%
2/79 • Number of events 3 • Up to 36 months
|
|
Investigations
White blood cell decreased
|
2.5%
2/79 • Number of events 2 • Up to 36 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.3%
1/79 • Number of events 2 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.5%
17/79 • Number of events 17 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.3%
5/79 • Number of events 7 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
10.1%
8/79 • Number of events 14 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.3%
5/79 • Number of events 7 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
3/79 • Number of events 3 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Gout attack
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Prostatitis attack
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Right Iliotibial band syndrome
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Degenerative disc disease
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.6%
6/79 • Number of events 6 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
2/79 • Number of events 2 • Up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung nodule
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodule
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodule in Right Lower Lobe
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Nervous system disorders
Dizziness
|
2.5%
2/79 • Number of events 2 • Up to 36 months
|
|
Nervous system disorders
Concussion
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Psychiatric disorders
Depression
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Renal and urinary disorders
Foaming urine
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Renal and urinary disorders
Stage III Chronic kidney disease
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
3/79 • Number of events 3 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Erythematous plaque and patches
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Surgical and medical procedures
Hip replacement
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
|
Vascular disorders
Hot flashes
|
1.3%
1/79 • Number of events 3 • Up to 36 months
|
|
Vascular disorders
Hypertension
|
17.7%
14/79 • Number of events 18 • Up to 36 months
|
|
Vascular disorders
Hypotension
|
1.3%
1/79 • Number of events 1 • Up to 36 months
|
Additional Information
Dr. Marcus Chen
National Heart, Lung, and Blood Institute at the National Institutes of Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place