Trial Outcomes & Findings for Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients (NCT NCT02966002)

NCT ID: NCT02966002

Last Updated: 2018-05-18

Results Overview

Change will be measured from baseline to retest after 8 weeks of treatment

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 9 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2018-05-18

Participant Flow

Participant milestones

Measure	Intervention: Aspirin 650 mg. Twice a day for 8 weeks Aspirin
Overall Study STARTED	9
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Intervention: Aspirin 650 mg. Twice a day for 8 weeks Aspirin
Overall Study Withdrawal by Subject	2
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients

Baseline characteristics by cohort

Measure	Intervention: Aspirin n=9 Participants 650 mg. Twice a day for 8 weeks Aspirin
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Total Cholesterol	138.6 mg/dL STANDARD_DEVIATION 16.6 • n=5 Participants
HDL Cholesterol	47.6 mg/dL STANDARD_DEVIATION 15.1 • n=5 Participants
High Sensitivity C-Reactive Protein	0.24 mg/dL STANDARD_DEVIATION 0.10 • n=5 Participants
Quality of Life	82.4 units on a scale STANDARD_DEVIATION 7.0 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Change will be measured from baseline to retest after 8 weeks of treatment

Outcome measures

Measure	Intervention: Aspirin n=5 Participants 650 mg. Twice a day for 8 weeks Aspirin
Change in Total Cholesterol	-0.6 mg/dL Standard Deviation 15.5

PRIMARY outcome

Timeframe: 8 weeks

Change will be measured from baseline to retest after 8 weeks of treatment

Outcome measures

Measure	Intervention: Aspirin n=5 Participants 650 mg. Twice a day for 8 weeks Aspirin
Change in HDL (High-Density Lipoprotein)-Cholesterol	0.4 mg/dL Standard Deviation 17.3

SECONDARY outcome

Timeframe: 8 weeks

Change will be measured from baseline to retest after 8 weeks of treatment

Outcome measures

Measure	Intervention: Aspirin n=5 Participants 650 mg. Twice a day for 8 weeks Aspirin
High Sensitivity CRP(C-Reactive Protein)	0.06 mg/dL Standard Deviation 0.09

SECONDARY outcome

Timeframe: 8 weeks

The Medical Outcomes Short-Form 36-Item Health Survey (SF-36) is a standardized health survey consisting of 36 questions that measure 8 dimensions of general health-related quality of life: physical functioning, role limitation due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and general mental health. The score is represented as an average of the individual question scores, and ranges from 0 (not functioning) to 100 (highest functioning). Higher scores indicate a better health status.

Outcome measures

Measure	Intervention: Aspirin n=5 Participants 650 mg. Twice a day for 8 weeks Aspirin
Quality of Life	86.5 units on a scale Standard Deviation 4.1

Adverse Events

Intervention: Aspirin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention: Aspirin n=5 participants at risk 650 mg. Twice a day for 8 weeks Aspirin
Gastrointestinal disorders Bloody Bowel Movement	20.0% 1/5 • 8 weeks

Additional Information

Adam Lubert

University of Michigan

Phone: 734-764-5177

Email: luberta@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place