Trial Outcomes & Findings for Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Progenitor Cells and Coronary Atherosclerosis in Humans (NCT NCT01067339)
NCT ID: NCT01067339
Last Updated: 2017-04-18
Results Overview
The change of coronary artery diameter was measured in response to a maximal dose of acetylcholine administered intracoronary during an invasive coronary endothelial function assessment. Percentage change in coronary artery diameter provides a measure of endothelium dependent epicardial function.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
70 participants
Primary outcome timeframe
baseline, six months
Results posted on
2017-04-18
Participant Flow
Subjects were recruited at the Mayo Clinic in Rochester, Minnesota between February 2010 and February 2015.
70 subjects signed informed consent, but 5 subjects withdrew (subject decision) prior to randomization.
Participant milestones
| Measure |
Darapladib
Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
|
Placebo
Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
34
|
|
Overall Study
COMPLETED
|
25
|
29
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Darapladib
Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
|
Placebo
Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
Baseline Characteristics
Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Progenitor Cells and Coronary Atherosclerosis in Humans
Baseline characteristics by cohort
| Measure |
Darapladib
n=25 Participants
Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
|
Placebo
n=29 Participants
Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 11.7 • n=39 Participants
|
54.0 years
STANDARD_DEVIATION 10.5 • n=41 Participants
|
54.5 years
STANDARD_DEVIATION 11.0 • n=35 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=39 Participants
|
26 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=39 Participants
|
29 participants
n=41 Participants
|
54 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: baseline, six monthsThe change of coronary artery diameter was measured in response to a maximal dose of acetylcholine administered intracoronary during an invasive coronary endothelial function assessment. Percentage change in coronary artery diameter provides a measure of endothelium dependent epicardial function.
Outcome measures
| Measure |
Darapladib
n=25 Participants
Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
|
Placebo
n=29 Participants
Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
|
|---|---|---|
|
Percentage Change in Coronary Artery Diameter
|
3 % change coronary artery diameter
Interval -9.0 to 15.0
|
3 % change coronary artery diameter
Interval -12.0 to 19.0
|
PRIMARY outcome
Timeframe: baseline, six monthsThe change in coronary blood flow was measured in response to maximal dose of acetylcholine administered intracoronary during an invasive coronary endothelial function assessment. Percentage change in coronary blood flow provides a measure of endothelium dependent microvascular function.
Outcome measures
| Measure |
Darapladib
n=25 Participants
Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
|
Placebo
n=29 Participants
Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
|
|---|---|---|
|
Percentage Change in Coronary Blood Flow (CBF)
|
-5 % change coronary blood flow
Interval -24.0 to 54.0
|
39 % change coronary blood flow
Interval -26.0 to 67.0
|
Adverse Events
Darapladib
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Darapladib
n=31 participants at risk
Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
|
Placebo
n=34 participants at risk
Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/34 • 6 months
|
|
Blood and lymphatic system disorders
Hematoma in groin
|
0.00%
0/31 • 6 months
|
5.9%
2/34 • Number of events 2 • 6 months
|
|
Cardiac disorders
Angina
|
3.2%
1/31 • Number of events 1 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Darapladib
n=31 participants at risk
Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
|
Placebo
n=34 participants at risk
Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
|
|---|---|---|
|
Infections and infestations
Cough, chest congestion, viral
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Fluid retention
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/34 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/34 • 6 months
|
|
Infections and infestations
Sinus Infection
|
6.5%
2/31 • Number of events 2 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Overdose
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Infections and infestations
Influenza
|
3.2%
1/31 • Number of events 1 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin abcess
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/34 • 6 months
|
|
Infections and infestations
Oral Thrush
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/34 • 6 months
|
|
Infections and infestations
Bladder infection
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Lower extremity edema
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/34 • 6 months
|
|
Injury, poisoning and procedural complications
Scalp laceration
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Fracture right wrist
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Cardiac disorders
Irregular heart rate
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
General disorders
Sweating around torso about 2 hours after taking study medication
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Product Issues
Allergic reaction
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Product Issues
Hypotension
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Product Issues
Diarrhea
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone spur
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Cardiac disorders
Chest discomfort/angina
|
9.7%
3/31 • Number of events 3 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Infections and infestations
Vaginal yeast infection
|
0.00%
0/31 • 6 months
|
5.9%
2/34 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Abdominal cramping and diarrhea
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Product Issues
Muscle aches
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Nervous system disorders
Inpatient psychiatric admission for pre-existing biolar disorder.
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Cardiac disorders
Myocardial bridge
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/34 • 6 months
|
|
General disorders
Chest pain
|
0.00%
0/31 • 6 months
|
5.9%
2/34 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Difficulty swallowing medications
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Back pain
|
0.00%
0/31 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
|
Cardiac disorders
Anomalous pulmonary vein and tricuspid valve repair
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/34 • 6 months
|
|
Infections and infestations
Kidney infection
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/34 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place