Trial Outcomes & Findings for Thromboxane Receptor Antagonist to Improve Endothelial Function (NCT NCT03962855)
NCT ID: NCT03962855
Last Updated: 2024-12-05
Results Overview
The change in Reactive Hyperemia Peripheral Index (RHI) as measured by Arterial Tonometry. The Reactive Hyperemia Index (RHI) is calculated as the ratio of post- to pre-occlusion peripheral arterial tone signals on the occluded side, normalized to the control side, and further adjusted for baseline vascular tone. RHI is automatically measured by the EndoPAT 2000 software. According to the manufacturer, an RHI value greater than 1.67 is considered normal, while a lower value indicates endothelial dysfunction and is associated with an increased risk of cardiovascular events.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Baseline to 4 weeks
Results posted on
2024-12-05
Participant Flow
Participant milestones
| Measure |
Ifetroban
Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks.
Ifetroban Sodium: Ifetroban sodium 250 mg capsule once daily for 4 weeks
|
Placebo
Matching placebo administered once daily for a minimum of 4 weeks.
Placebo: Placebo arm to match Ifetroban Sodium once daily for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
29
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Ifetroban
Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks.
Ifetroban Sodium: Ifetroban sodium 250 mg capsule once daily for 4 weeks
|
Placebo
Matching placebo administered once daily for a minimum of 4 weeks.
Placebo: Placebo arm to match Ifetroban Sodium once daily for 4 weeks.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Thromboxane Receptor Antagonist to Improve Endothelial Function
Baseline characteristics by cohort
| Measure |
Ifetroban
n=29 Participants
Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks.
Ifetroban Sodium: Ifetroban sodium 250 mg capsule once daily for 4 weeks
|
Placebo
n=28 Participants
Matching placebo administered once daily for a minimum of 4 weeks.
Placebo: Placebo arm to match Ifetroban Sodium once daily for 4 weeks.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.3 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
62.4 Years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
63 Years
STANDARD_DEVIATION 8.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 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
|
1 Participants
n=7 Participants
|
1 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 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
United States
|
29 participants
n=5 Participants
|
28 participants
n=7 Participants
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 weeksPopulation: 5 participants were withdrawn from the placebo group
The change in Reactive Hyperemia Peripheral Index (RHI) as measured by Arterial Tonometry. The Reactive Hyperemia Index (RHI) is calculated as the ratio of post- to pre-occlusion peripheral arterial tone signals on the occluded side, normalized to the control side, and further adjusted for baseline vascular tone. RHI is automatically measured by the EndoPAT 2000 software. According to the manufacturer, an RHI value greater than 1.67 is considered normal, while a lower value indicates endothelial dysfunction and is associated with an increased risk of cardiovascular events.
Outcome measures
| Measure |
Ifetroban
n=29 Participants
Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks.
Ifetroban Sodium: Ifetroban sodium 250 mg capsule once daily for 4 weeks
|
Placebo
n=23 Participants
Matching placebo administered once daily for a minimum of 4 weeks.
Placebo: Placebo arm to match Ifetroban Sodium once daily for 4 weeks.
|
|---|---|---|
|
Change in Reactive Hyperemia Index (RHI)
|
-0.01 percentage index change
Interval -0.36 to 0.34
|
0.21 percentage index change
Interval -0.17 to 0.51
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksPopulation: 5 participants from the placebo group were withdrawn from the study
The measure is the change in flow-mediated vasodilation (FMD) as measured by Brachial vasoractivity
Outcome measures
| Measure |
Ifetroban
n=29 Participants
Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks.
Ifetroban Sodium: Ifetroban sodium 250 mg capsule once daily for 4 weeks
|
Placebo
n=23 Participants
Matching placebo administered once daily for a minimum of 4 weeks.
Placebo: Placebo arm to match Ifetroban Sodium once daily for 4 weeks.
|
|---|---|---|
|
Change in Percent Flow-mediated Vasodilation (FMD)
|
11.36 percentage
Interval -7.93 to 61.36
|
-15.83 percentage
Interval -28.71 to -2.52
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksUrinary urinary TXB2-M measured by 11-dhTXB2 ELISA
Outcome measures
| Measure |
Ifetroban
n=29 Participants
Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks.
Ifetroban Sodium: Ifetroban sodium 250 mg capsule once daily for 4 weeks
|
Placebo
n=23 Participants
Matching placebo administered once daily for a minimum of 4 weeks.
Placebo: Placebo arm to match Ifetroban Sodium once daily for 4 weeks.
|
|---|---|---|
|
Change in Urinary TXB2-M
|
370.7 pg/mg creatinine
Interval 11.6 to 884.8
|
-210.9 pg/mg creatinine
Interval -895.1 to 85.7
|
Adverse Events
Ifetroban
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Ifetroban
n=29 participants at risk
Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks.
Ifetroban Sodium: Ifetroban sodium 250 mg capsule once daily for 4 weeks
|
Placebo
n=28 participants at risk
Matching placebo administered once daily for a minimum of 4 weeks.
Placebo: Placebo arm to match Ifetroban Sodium once daily for 4 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Hepatobiliary disorders
Cholecistitis
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Celulitis on the left foot and ankle
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Wound complication (edema, erythema, pain)
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Diabetic skin ulceration
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Cardiac disorders
Cardiac chest pain
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 2 • 6 weeks
|
|
Cardiac disorders
Myocardial infaction
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 2 • 6 weeks
|
Other adverse events
| Measure |
Ifetroban
n=29 participants at risk
Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks.
Ifetroban Sodium: Ifetroban sodium 250 mg capsule once daily for 4 weeks
|
Placebo
n=28 participants at risk
Matching placebo administered once daily for a minimum of 4 weeks.
Placebo: Placebo arm to match Ifetroban Sodium once daily for 4 weeks.
|
|---|---|---|
|
Nervous system disorders
Headache
|
13.8%
4/29 • Number of events 4 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
17.2%
5/29 • Number of events 5 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
General disorders
Fatigue
|
13.8%
4/29 • Number of events 4 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
13.8%
4/29 • Number of events 4 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.3%
3/29 • Number of events 3 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Investigations
AST increased
|
6.9%
2/29 • Number of events 2 • 6 weeks
|
0.00%
0/28 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
6.9%
2/29 • Number of events 2 • 6 weeks
|
0.00%
0/28 • 6 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
2/29 • Number of events 2 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Ear and labyrinth disorders
Epistaxis
|
3.4%
1/29 • Number of events 2 • 6 weeks
|
0.00%
0/28 • 6 weeks
|
|
Ear and labyrinth disorders
Nasal congestion
|
6.9%
2/29 • Number of events 2 • 6 weeks
|
0.00%
0/28 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
6.9%
2/29 • Number of events 2 • 6 weeks
|
7.1%
2/28 • Number of events 2 • 6 weeks
|
|
Ear and labyrinth disorders
Pharyngitis
|
6.9%
2/29 • Number of events 2 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Renal and urinary disorders
Urinary urgency
|
3.4%
1/29 • Number of events 2 • 6 weeks
|
0.00%
0/28 • 6 weeks
|
|
Investigations
ALT increased
|
3.4%
1/29 • Number of events 1 • 6 weeks
|
0.00%
0/28 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
1/29 • Number of events 1 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Gastrointestinal disorders
Bloating
|
3.4%
1/29 • Number of events 1 • 6 weeks
|
0.00%
0/28 • 6 weeks
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29 • Number of events 1 • 6 weeks
|
7.1%
2/28 • Number of events 2 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.4%
1/29 • Number of events 1 • 6 weeks
|
10.7%
3/28 • Number of events 3 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.4%
1/29 • Number of events 1 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.4%
1/29 • Number of events 1 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Nervous system disorders
Insomnia
|
3.4%
1/29 • Number of events 1 • 6 weeks
|
0.00%
0/28 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
1/29 • Number of events 1 • 6 weeks
|
7.1%
2/28 • Number of events 2 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
3.4%
1/29 • Number of events 1 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Nervous system disorders
Situational syncope
|
3.4%
1/29 • Number of events 1 • 6 weeks
|
0.00%
0/28 • 6 weeks
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • Number of events 1 • 6 weeks
|
0.00%
0/28 • 6 weeks
|
|
Metabolism and nutrition disorders
Alcohol Intolerance Syndrome
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
General disorders
Anemia
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Nervous system disorders
Depression
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Immune system disorders
Leucocytosis
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Immune system disorders
Lymphocytopenia
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Infections and infestations
Neutrophilia
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
General disorders
Fever
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Nervous system disorders
Anxiety
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Investigations
Creatinine increased
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/29 • 6 weeks
|
3.6%
1/28 • Number of events 1 • 6 weeks
|
|
Surgical and medical procedures
Surgical and medical procedure
|
0.00%
0/29 • 6 weeks
|
7.1%
2/28 • Number of events 4 • 6 weeks
|
Additional Information
Jeffrey J Rade MD
University of Massachusetts Medical School
Phone: 774-441-6310
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place