NCT02966002

Brief Summary

Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop complications many years after their operation. Studies have shown that some of these patients develop an ongoing inflammatory state, which may be the cause of these late complications. Aspirin is a common over the counter anti-inflammatory medication used for many other chronic diseases. This study may help determine if aspirin therapy can limit the inflammation seen in Fontan patients and prevent these late complications.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2017

Completed
12 months until next milestone

Results Posted

Study results publicly available

May 18, 2018

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

November 15, 2016

Results QC Date

April 17, 2018

Last Update Submit

May 17, 2018

Conditions

Fontan Procedure

Outcome Measures

Primary Outcomes (2)

  • Change in Total Cholesterol

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

    8 weeks

  • Change in HDL (High-Density Lipoprotein)-Cholesterol

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

    8 weeks

Secondary Outcomes (2)

  • High Sensitivity CRP(C-Reactive Protein)

    8 weeks

  • Quality of Life

    8 weeks

Study Arms (1)

Intervention: aspirin

EXPERIMENTAL

650 mg. Twice a day for 8 weeks

Drug: Aspirin

Interventions

AspirinDRUG
Intervention: aspirin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults who have Fontan repair of single ventricle

You may not qualify if:

  • Active protein losing enteropathy within the past three years
  • Congestive heart failure
  • Active arrhythmias
  • Taking Coumadin (Warfarin)
  • Bleeding disorder
  • Known esophageal varicies
  • Consuming more than 10 alcoholic drinks per week.
  • Pregnant
  • Planning to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Adam Lubert
Organization
University of Michigan
luberta@med.umich.edu
734-764-5177

Study Officials

  • Adam Lubert, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor, Pediatric Cardiology

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 17, 2016

Study Start

April 1, 2016

Primary Completion

May 25, 2017

Study Completion

May 25, 2017

Last Updated

May 18, 2018

Results First Posted

May 18, 2018

Record last verified: 2018-05

Locations

US(1)