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Nonsteroidal Anti-inflammatory Drug
Low-Dose Aspirin for Postpartum Pre-eclampsia (PAPVASC Trial)
Phase < 1
Waitlist Available
Led By Graeme N Smith, MD, PhD
Research Sponsored by Dr. Graeme Smith
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months postpartum
Awards & highlights
PAPVASC Trial Summary
This trial will be the first to assess the efficacy of LD-ASA on postpartum vascular function in women with a history of severe PE.
Who is the study for?
This trial is for women who had severe preeclampsia during a recent single pregnancy. They must have high blood pressure and protein in their urine or other specific symptoms of severe preeclampsia. Women with drug/alcohol abuse history, certain chronic diseases, or on conflicting medications cannot participate.Check my eligibility
What is being tested?
The study tests if low-dose aspirin (81 mg daily) can improve vascular health postpartum in women who had severe preeclampsia, compared to a placebo. It's randomized and controlled: participants don't choose which group they're in and are tested before and after the 6-month treatment period.See study design
What are the potential side effects?
Low-dose aspirin may cause bleeding issues, gastrointestinal problems like stomach ulcers or heartburn, allergic reactions, or increase the risk of Reye's syndrome in some populations.
PAPVASC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months postpartum
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Endothelium-Dependent Dilation
Secondary outcome measures
Blood Pressure
Body Mass Index
Concentration of Placental Growth Factor
+9 morePAPVASC Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PO LD-ASAExperimental Treatment1 Intervention
Study participants who are assigned to the oral aspirin arm of the study will receive 81mg oral aspirin. Over-encapsulated 81mg aspirin tablets will be used. Study participants in this arm will take 81mg aspirin daily for 6 months.
Group II: PO PlaceboPlacebo Group1 Intervention
A standard placebo pill, the same size, shape and color of the oral aspirin will be used. The placebo pills will be over-encapsulated in the same manner as the aspirin tablets. The placebo will be administered to the participants randomized to placebo group in the same manner the oral aspirin would be administered - they will take the pill daily for 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low-dose aspirin
2019
Completed Phase 2
~240
Find a Location
Who is running the clinical trial?
Dr. Graeme SmithLead Sponsor
Graeme N Smith, MD, PhDPrincipal InvestigatorQueen's Department of Obstetrics and Gynaecology
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had issues with drugs or alcohol within the past year, or you are currently undergoing treatment for substance abuse.You have Raynaud's phenomenon.You have unstable chest pain, heart problems, severe irregular heartbeat, or kidney failure.You are allergic to the aspirin used in the study.You have growths in your nose called nasal polyps.You have a history of diabetes that was present before joining the study.You have recently experienced problems with your brain or vision.
Research Study Groups:
This trial has the following groups:- Group 1: PO Placebo
- Group 2: PO LD-ASA
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been enrolled in this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this medical research initiative began recruiting patients on September 14th of 2020 and was last modified April 19th 2022. The experiment is currently seeking 44 participants from a single healthcare facility."
Answered by AI
What health issues can be remedied by taking Low-dose aspirin?
"Low-dose aspirin is an efficacious treatment for a variety of medical issues, such as percutaneous coronary intervention (PCI), dental procedures, and inflammation."
Answered by AI
Is this research recruiting participants at present?
"Affirmative. Clinicaltrials.gov declares that this clinical trial, which went live on September 14th 2020, is presently recruiting patients. 44 individuals need to be enrolled from a single medical centre."
Answered by AI
Is this an unprecedented clinical experiment?
"Currently, there are 167 active clinical trials concerning the use of Low-dose aspirin. These trials span across thirteen hundred ninety eight cities and fifty seven countries, beginning in 2005 with a Phase 4 trial sponsored by Abbott that involved 15480 participants. Since then, an additional 572 studies have been conducted."
Answered by AI
Who else is applying?
What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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