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Aspirin and Preeclampsia

Primary Purpose

Preeclampsia Postpartum

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aspirin 81 mg
Placebo
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preeclampsia Postpartum focused on measuring Preeclampsia, Postpartum GLS Levels, Postpartum Activin A Levels, Aspirin, Cardiac Postpartum Therapy, Hypertension, Cardiovascular disease

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pregnant Adults between 18 and 45 years of age
  2. Diagnosed with preeclampsia
  3. Presenting for delivery with a singleton gestation.

Exclusion Criteria:

  1. We will exclude patients in labor
  2. Patients with preexisting cardiomyopathy, chronic hypertension, ischemic or valvular heart disease, pulmonary disease, diabetes mellitus, chronic kidney disease, multiple gestation
  3. Plan to deliver outside of the participating site
  4. Co-enrolled in other trials that might affect the patients taking the study medication, as determined by the PI.
  5. Aspirin allergy
  6. Clear indication for aspirin therapy or contraindication to aspirin therapy
  7. Clinically significant conditions that might limit adherence to trial regimen (e.g., peptic ulcer disease, history of gastrointestinal bleeds, bleeding disorders)
  8. Currently or planning on taking any nonsteroidal anti-inflammatory drugs while they are participating in this study.
  9. Those who cannot provide consent

Sites / Locations

  • University of Chicago HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Intervention Arm

Placebo Arm

Observational Arm

Arm Description

60 subjects will be randomly assigned to this arm. The subjects in this arm will receive a daily dose of aspirin 81 mg.

60 subjects will be randomly assigned to this arm. The subjects in this arm will receive a daily dose of a placebo pill

60 subjects will be placed in the observational arm. These subjects will not receive any intervention but will be followed and asked to return at the same time interval as the other 2 groups.

Outcomes

Primary Outcome Measures

Difference in Activin A levels
The primary outcome will compare Activin A levels at 6 months between patients randomized to aspirin therapy versus placebo and the observational group.
GLS percentages
The primary outcome will compare GLS levels as a percentage (%) at 6 months between patients randomized to aspirin therapy versus placebo and the observational group.

Secondary Outcome Measures

Mean Arterial Pressure
Difference in mean arterial pressure in subjects, from their baseline to 6 month TTE
Ejection Fraction %
Comparing the difference in the ejection fraction percentages, from the subjects baseline to 6 month TEE.
Deceleration Time
Comparing the difference between deceleration time from subjects from their baseline to 6 month TTE.
Mitral Annular Motion
Comparing the difference between mitral annular motion, in millimeters (mm), from subjects baseline to 6 month TTE.
Left Atrial Volume Index
Comparing the difference between left atrial volume index, from the subjects baseline to 6 month TTE.

Full Information

First Posted
July 13, 2020
Last Updated
November 23, 2022
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04479072
Brief Title
Aspirin and Preeclampsia
Official Title
Aspirin to Prevent Cardiac Dysfunction in Preeclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single-center, double-blind, randomized, placebo-controlled clinical trial. Peripartum and postpartum Activin A are significantly elevated in women with preeclampsia. Our hypothesis is that elevated Activin A levels reflect a remediable signal and that reducing postpartum Activin A levels with aspirin therapy will improve (GLS) in preeclamptic patients.
Detailed Description
The primary objective of the main part of this trial is to mechanistically compare the effect of postpartum aspirin therapy versus placebo in preeclamptic patients identified as high risk for postpartum cardiac dysfunction using Activin A. The intent is to evaluate the effect of selective treatment based on Activin A status rather than treatment for all postpartum preeclamptic women. After informed consent, 5cc of blood will be collected from the median cubital vein on antepartum admission to labor and delivery for Activin A screening. The patient will be subjected to a total of 2 such blood draws- a single draw at screening, one at their 6 month postpartum visit. The member of the study team carrying out the blood draw will immediately label the specimen in the presence of the subject, after the collection and before leaving the patient's bedside, room, cubicle or surgical suite. The guidelines from, "The University of Chicago Medicine Policy and Procedure Manual - Phlebotomy Service Infection Control 04-26" will be followed for specimen collection and transport. Activin A levels based on our previous data will be classified as elevated if greater than 23.74 ng/ml in the last trimester of pregnancy (4). This threshold was selected on the basis of our prior data suggesting an inflection point in the rate of abnormal GLS postpartum at this concentration. Patients with elevated Activin A levels will be randomized to a placebo group receiving routine postpartum cardiovascular standard of care or to an intervention arm with 81 mg daily aspirin therapy added to care at their postpartum delivery stay. The rationale for only randomizing women with elevated Activin A levels is that among women with an elevated Activin A antepartum, 85% developed abnormalities in GLS at one year postpartum versus 25% in women with non-elevated Activin A levels. Women whose Activin A levels are not elevated will receive the same care as that provided to the placebo group and will also be followed for one year (n=60). All other subjects who meet the criterial of elevated Activin A levels, will either be randomized to the aspirin therapy group (N = 60) or a placebo group (N = 60). The investigators choose postpartum Aspirin therapy post-delivery to avoid any immediate delivery or C-section associated bleeding complications and to coincide with their postpartum well-baby visit. The investigator will determine the blood Activin A levels at 6 months after delivery, measured using ELISA. The samples will be assayed for Activin A level using commercially available ELISA kits (Ansh Labs; Webster, TX) following the manufacturer's recommendations. Each sample will be run in triplicate and the values averaged. GLS at 6 months after delivery will be measured using fully automated vendor-independent software that uses a computer learning algorithm to facilitate endocardial border detection. Mean arterial pressure, and other indices of systolic and diastolic function (ejection fraction (EF), early filling/atrial contraction (E/A), deceleration time (DT), mitral annular motion (E'), and left atrial volume index) measured at the baseline and 6 months postpartum. Transthoracic echocardiograms will be performed and reported according to American Society of Echocardiography guidelines. Ejection fraction and left atrial volume will be calculated using the Simpson's biplane disc method. Left ventricular mass index (LVMI) will be calculated using the area length method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia Postpartum
Keywords
Preeclampsia, Postpartum GLS Levels, Postpartum Activin A Levels, Aspirin, Cardiac Postpartum Therapy, Hypertension, Cardiovascular disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Model Description
Main Study: Subjects will be randomized to two arms. One arm will receive a daily dose of aspirin 81 mg, starting at their baseline visit. The other arm will receive daily dose of placebo pill at their baseline visit. There will be a third arm, where subjects will not receive any study drug and will be considered the observational arm. Sub-Study: Subjects who completed the main part of the study and choose to participate will be randomized once more into one of two arms for the purposes of the sub-study. One arm will receive the GDMP, which includes the RPM program. The other arm will not receive the GDMP and will continue thier usual standard of care course per thier treating physician.
Masking
ParticipantInvestigator
Masking Description
The study team and all randomized subjects will be blinded to which arm they were placed in during the main part of the study. Subjects in the observational group will not be randomized and not given an intervention. The sub-study portion has no blinding attached to it
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Active Comparator
Arm Description
60 subjects will be randomly assigned to this arm. The subjects in this arm will receive a daily dose of aspirin 81 mg.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
60 subjects will be randomly assigned to this arm. The subjects in this arm will receive a daily dose of a placebo pill
Arm Title
Observational Arm
Arm Type
No Intervention
Arm Description
60 subjects will be placed in the observational arm. These subjects will not receive any intervention but will be followed and asked to return at the same time interval as the other 2 groups.
Intervention Type
Drug
Intervention Name(s)
Aspirin 81 mg
Other Intervention Name(s)
acetylsalicylic acid 81 mg
Intervention Description
Subjects in the interventional arm will receive a daily dose of aspirin 81 mg, starting at their baseline visit and to be taken up to their 6-month follow-up visit.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects in this group will receive a daily dose of a placebo pill, starting at their baseline visit and to be taken up to their 6-month follow-up visit.
Primary Outcome Measure Information:
Title
Difference in Activin A levels
Description
The primary outcome will compare Activin A levels at 6 months between patients randomized to aspirin therapy versus placebo and the observational group.
Time Frame
6 Months
Title
GLS percentages
Description
The primary outcome will compare GLS levels as a percentage (%) at 6 months between patients randomized to aspirin therapy versus placebo and the observational group.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mean Arterial Pressure
Description
Difference in mean arterial pressure in subjects, from their baseline to 6 month TTE
Time Frame
6 Months
Title
Ejection Fraction %
Description
Comparing the difference in the ejection fraction percentages, from the subjects baseline to 6 month TEE.
Time Frame
6 Months
Title
Deceleration Time
Description
Comparing the difference between deceleration time from subjects from their baseline to 6 month TTE.
Time Frame
6 Months
Title
Mitral Annular Motion
Description
Comparing the difference between mitral annular motion, in millimeters (mm), from subjects baseline to 6 month TTE.
Time Frame
6 Months
Title
Left Atrial Volume Index
Description
Comparing the difference between left atrial volume index, from the subjects baseline to 6 month TTE.
Time Frame
6 Months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women with preeclampsia
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant Adults between 18 and 45 years of age Diagnosed with preeclampsia Presenting for delivery with a singleton gestation. Exclusion Criteria: We will exclude patients in labor Patients with preexisting cardiomyopathy, chronic hypertension, ischemic or valvular heart disease, pulmonary disease, diabetes mellitus, chronic kidney disease, multiple gestation Plan to deliver outside of the participating site Co-enrolled in other trials that might affect the patients taking the study medication, as determined by the PI. Aspirin allergy Clear indication for aspirin therapy or contraindication to aspirin therapy Clinically significant conditions that might limit adherence to trial regimen (e.g., peptic ulcer disease, history of gastrointestinal bleeds, bleeding disorders) Currently or planning on taking any nonsteroidal anti-inflammatory drugs while they are participating in this study. Those who cannot provide consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sajid Shahul, MD, PhD
Phone
773-398-2956
Email
sshahul1@dacc.uchicago.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Duncan, RN
Phone
7738342892
Email
cduncan@bsd.uchicago.edu
Facility Information:
Facility Name
University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sajid Shahul, MD, PhD
Phone
773-398-2956
Email
sshahul1@dacc.uchicago.edu
First Name & Middle Initial & Last Name & Degree
John Dreixler, PhD
Phone
773-702-6700
Email
JDreixle@dacc.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Sarosh Rana, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Aspirin and Preeclampsia

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