Trial Outcomes & Findings for The Vascular Biology of Dipyridamole in Peripheral Arterial Disease (PAD) (NCT NCT00906035)
NCT ID: NCT00906035
Last Updated: 2017-09-05
Results Overview
No analysis could be performed due to the insufficent number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Predose and dosing days 30, 90 and 180
Results posted on
2017-09-05
Participant Flow
Participant milestones
| Measure |
Dipyridamole 200mg and Aspirin 25mg Bid
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.
Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
Dipyridamole 200 mg Bid
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.
Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
Aspirin 25 mg Bid
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.
Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
0
|
Reasons for withdrawal
| Measure |
Dipyridamole 200mg and Aspirin 25mg Bid
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.
Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
Dipyridamole 200 mg Bid
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.
Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
Aspirin 25 mg Bid
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.
Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
0
|
Baseline Characteristics
The Vascular Biology of Dipyridamole in Peripheral Arterial Disease (PAD)
Baseline characteristics by cohort
| Measure |
Dipyridamole 200mg and Aspirin 25mg Bid
n=8 Participants
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.
Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
Dipyridamole 200 mg Bid
n=9 Participants
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.
Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
Aspirin 25 mg Bid
n=8 Participants
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.
Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
Total
n=25 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
25 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Predose and dosing days 30, 90 and 180Population: Data could not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria. Data could not be analyzed due to insufficient number of participants enrolled.
No analysis could be performed due to the insufficent number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose and dosing days 30, 90 and 180.Population: Data could not be analyzed due to insufficient number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.
Done by doppler ultrasound. Data could not be analyzed due to insufficient number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose and dosing days 30, 90 and 180.Population: Data could not be analyzed due to insufficient number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.
Reporting blood oxygenation. Data could not be analyzed due to insufficient number of participants enrolled. Difficulty finding participants who fit into the inclusion/exclusion criteria.
Outcome measures
Outcome data not reported
Adverse Events
Dipyridamole 200mg and Aspirin 25mg Bid
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Dipyridamole 200 mg Bid
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Aspirin 25 mg Bid
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dipyridamole 200mg and Aspirin 25mg Bid
n=8 participants at risk
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.
Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
Dipyridamole 200 mg Bid
n=9 participants at risk
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.
Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
Aspirin 25 mg Bid
n=8 participants at risk
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.
Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac catherization of the pelvis
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/8 • 5 years
|
|
Cardiac disorders
Chest pain
|
0.00%
0/8 • 5 years
|
0.00%
0/9 • 5 years
|
12.5%
1/8 • Number of events 3 • 5 years
|
|
Surgical and medical procedures
Surgical removal of renal tumor
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/8 • 5 years
|
|
Surgical and medical procedures
balloon angioplasty left leg
|
0.00%
0/8 • 5 years
|
11.1%
1/9 • Number of events 1 • 5 years
|
0.00%
0/8 • 5 years
|
Other adverse events
| Measure |
Dipyridamole 200mg and Aspirin 25mg Bid
n=8 participants at risk
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.
Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
Dipyridamole 200 mg Bid
n=9 participants at risk
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.
Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
Aspirin 25 mg Bid
n=8 participants at risk
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.
Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
|
|---|---|---|---|
|
Vascular disorders
intermittent claudication
|
25.0%
2/8 • 5 years
|
33.3%
3/9 • 5 years
|
25.0%
2/8 • 5 years
|
|
Cardiac disorders
Angina
|
12.5%
1/8 • 5 years
|
0.00%
0/9 • 5 years
|
12.5%
1/8 • 5 years
|
|
General disorders
Diarrhea
|
0.00%
0/8 • 5 years
|
11.1%
1/9 • 5 years
|
12.5%
1/8 • 5 years
|
|
General disorders
Headache
|
25.0%
2/8 • 5 years
|
0.00%
0/9 • 5 years
|
12.5%
1/8 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place