Trial Outcomes & Findings for A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension (NCT NCT00384865)
NCT ID: NCT00384865
Last Updated: 2017-07-21
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Measured at 6 months
Results posted on
2017-07-21
Participant Flow
Participant milestones
| Measure |
Aspirin 81 mg + Simvastatin 40 mg
Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months
Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months
|
Aspirin 81 mg + Placebo
Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months
Placebo: Placebo, taken orally, once a day for 6 months
|
Placebo + Simvastatin 40 mg
Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months
Placebo: Placebo, taken orally, once a day for 6 months
|
Placebo + Placebo
Placebo: Placebo, taken orally, once a day for 6 months
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
16
|
|
Overall Study
Completed Six Month Assessment
|
11
|
12
|
15
|
11
|
|
Overall Study
COMPLETED
|
16
|
16
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Aspirin 81 mg + Simvastatin 40 mg
n=16 Participants
Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months
Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months
|
Aspirin 81 mg + Placebo
n=16 Participants
Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months
Placebo: Placebo, taken orally, once a day for 6 months
|
Placebo + Simvastatin 40 mg
n=16 Participants
Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months
Placebo: Placebo, taken orally, once a day for 6 months
|
Placebo + Placebo
n=16 Participants
Placebo: Placebo, taken orally, once a day for 6 months
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.6 Years
STANDARD_DEVIATION 16.6 • n=5 Participants
|
56.75 Years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
58.6 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
63.5 Years
STANDARD_DEVIATION 14.2 • n=4 Participants
|
59.6 Years
STANDARD_DEVIATION 13.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured at 6 monthsOutcome measures
| Measure |
Aspirin 81 mg
n=32 Participants
Aspirin 81 mg, taken orally, once a day for 6 months
|
Aspirin Placebo
n=33 Participants
Placebo, taken orally, once a day for 6 months
|
Simvastatin 40 mg
n=32 Participants
Simvastatin 40 mg, taken orally, once a day for 6 months
|
Simvastatin Placebo
n=33 Participants
Placebo, taken orally, once a day for 6 months
|
|---|---|---|---|---|
|
Distance Walked in Six Minutes
|
438.0 meters
Interval 415.9 to 460.1
|
438.5 meters
Interval 419.2 to 457.8
|
425.0 meters
Interval 400.2 to 449.9
|
452.7 meters
Interval 431.9 to 473.4
|
SECONDARY outcome
Timeframe: Measured at 6 monthsDefined by the addition of new PAH therapies or dose increases in previously stable PAH therapy, hospitalization for right-sided heart failure, lung transplantation, atrial septostomy, and cardiovascular and all-cause death.
Outcome measures
| Measure |
Aspirin 81 mg
n=32 Participants
Aspirin 81 mg, taken orally, once a day for 6 months
|
Aspirin Placebo
n=33 Participants
Placebo, taken orally, once a day for 6 months
|
Simvastatin 40 mg
n=32 Participants
Simvastatin 40 mg, taken orally, once a day for 6 months
|
Simvastatin Placebo
n=33 Participants
Placebo, taken orally, once a day for 6 months
|
|---|---|---|---|---|
|
Time to Clinical Worsening Events (Number of Events)
|
2 events
|
6 events
|
4 events
|
4 events
|
SECONDARY outcome
Timeframe: Measured at 6 monthsPlease refer to the Adverse Event Tables for specific information
Outcome measures
| Measure |
Aspirin 81 mg
n=32 Participants
Aspirin 81 mg, taken orally, once a day for 6 months
|
Aspirin Placebo
n=33 Participants
Placebo, taken orally, once a day for 6 months
|
Simvastatin 40 mg
n=32 Participants
Simvastatin 40 mg, taken orally, once a day for 6 months
|
Simvastatin Placebo
n=33 Participants
Placebo, taken orally, once a day for 6 months
|
|---|---|---|---|---|
|
Adverse Events
|
59 events
|
66 events
|
66 events
|
58 events
|
Adverse Events
Aspirin 81 mg
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
Aspirin Placebo
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Simvastatin 40 mg
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Simvastatin Placebo
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aspirin 81 mg
n=32 participants at risk
Aspirin 81 mg, taken orally, once a day for 6 months
|
Aspirin Placebo
n=33 participants at risk
Placebo, taken orally, once a day for 6 months
|
Simvastatin 40 mg
n=32 participants at risk
Simvastatin 40 mg, taken orally, once a day for 6 months
|
Simvastatin Placebo
n=33 participants at risk
Placebo, taken orally, once a day for 6 months
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Major Bleeding Episode
|
12.5%
4/32 • Number of events 4 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
3.0%
1/33 • Number of events 1 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
0.00%
0/32 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
0.00%
0/33 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
Other adverse events
| Measure |
Aspirin 81 mg
n=32 participants at risk
Aspirin 81 mg, taken orally, once a day for 6 months
|
Aspirin Placebo
n=33 participants at risk
Placebo, taken orally, once a day for 6 months
|
Simvastatin 40 mg
n=32 participants at risk
Simvastatin 40 mg, taken orally, once a day for 6 months
|
Simvastatin Placebo
n=33 participants at risk
Placebo, taken orally, once a day for 6 months
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
31.2%
10/32 • Number of events 10 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
33.3%
11/33 • Number of events 11 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
37.5%
12/32 • Number of events 12 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
27.3%
9/33 • Number of events 9 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
|
General disorders
Bruising
|
25.0%
8/32 • Number of events 8 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
24.2%
8/33 • Number of events 8 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
31.2%
10/32 • Number of events 10 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
18.2%
6/33 • Number of events 6 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.4%
3/32 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
15.2%
5/33 • Number of events 5 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
9.4%
3/32 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
15.2%
5/33 • Number of events 5 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
|
General disorders
Headache
|
15.6%
5/32 • Number of events 5 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
9.1%
3/33 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
15.6%
5/32 • Number of events 5 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
9.1%
3/33 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
|
Gastrointestinal disorders
Diarrhea
|
9.4%
3/32 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
12.1%
4/33 • Number of events 4 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
9.4%
3/32 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
12.1%
4/33 • Number of events 4 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
|
Infections and infestations
Other Infections
|
12.5%
4/32 • Number of events 4 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
12.1%
4/33 • Number of events 4 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
12.5%
4/32 • Number of events 4 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
12.1%
4/33 • Number of events 4 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
2/32 • Number of events 2 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
12.1%
4/33 • Number of events 4 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
9.4%
3/32 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
9.1%
3/33 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.4%
3/32 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
9.1%
3/33 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
12.5%
4/32 • Number of events 4 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
6.1%
2/33 • Number of events 2 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
3/32 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
9.1%
3/33 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
12.5%
4/32 • Number of events 4 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
6.1%
2/33 • Number of events 2 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
3.1%
1/32 • Number of events 1 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
9.1%
3/33 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
3.1%
1/32 • Number of events 1 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
9.1%
3/33 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
|
Hepatobiliary disorders
Increased Transaminases
|
3.1%
1/32 • Number of events 1 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
9.1%
3/33 • Number of events 3 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
6.2%
2/32 • Number of events 2 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
6.1%
2/33 • Number of events 2 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
|
General disorders
Insomnia
|
3.1%
1/32 • Number of events 1 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
6.1%
2/33 • Number of events 2 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
3.1%
1/32 • Number of events 1 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
6.1%
2/33 • Number of events 2 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
|
Blood and lymphatic system disorders
Minor Bleeding Episode
|
34.4%
11/32 • Number of events 11 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
36.4%
12/33 • Number of events 12 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
43.8%
14/32 • Number of events 14 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
39.4%
13/33 • Number of events 13 • Adverse event data was collected for each subject from screening through 6 months after enrollment/randomization
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place