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Nonsteroidal Anti-inflammatory Drug

Low-Dose Aspirin for Preeclampsia Prevention (ASAPP Trial)

Q: Are individuals of ____ years old or younger being accepted for this research project?

This study's requirements for participants state that they must be between 18-60 years old. There are 27 studies available for patients who are not yet adults and 216 trials specifically designed for seniors.

Q: For what medical purposes is 162mg ASA typically prescribed?

A 162mg ASA dosage is frequently used to treat percutaneous coronary intervention (pci) but can also help with other conditions like dental procedures, inflammation and neck <a href="https://www.withpower.com/clinical-trials/pain">pain</a>.

Q: What are the goals that this trial is hoping to achieve?

This clinical trial's primary outcome will be evaluated over a 9-month period for each patient, from recruitment to 6 weeks postpartum. The primary outcome is the incidence of preeclampsia with severe features. Secondary outcomes include aspirin adherence (defined as pregnant women's adherence to 81mg or 162mg of daily low-dose aspirin, using a validated Simplified Medication Adherence Questionnaire), time-to-event for preeclampsia and gestational age at onset of PE (comparing the time it takes for development of preeclampsia in women treated with 81mg vs162mg of aspirin per day,

Q: What dosage of aspirin has the FDA cleared for use?

There is evidence from previous trials to support the efficacy of 162mg ASA, so it received a score of 3.

Q: How do I qualify to participate in this experiment?

400 expectant mothers suffering from pre-eclampsia will be recruited for this study, provided they are between 18-60 years old. Eligibility criteria for participants include: a history of PE in a past <a href="https://www.withpower.com/clinical-trials/pregnancy">pregnancy</a>, carrying more than one fetus, or an autoimmune disease such as <a href="https://www.withpower.com/clinical-trials/lupus">lupus</a> erythematous or antiphospholipid syndrome.

Q: Are there any remaining vacancies for patients in this clinical trial?

This clinical trial is actively looking for participants, as reported on clinicaltrials.gov. The original posting date was 10/21/2019, and the most recent update was 12/9/2021.

Q: Are there other similar clinical trials to this one?

162mg ASA has been under research since 2002 when the first trial was conducted by Sanofi. 413 patients were involved in this initial study which led to Phase 3 drug approval for 162mg ASA. Currently, there are 181 active studies being conducted for162mg ASA across 1451 cities and 61 countries.

Phase 3

Waitlist Available

Led By Line Malha, MD, MS

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Renal disease (proteinuria ≥300mg/day or estimated GFR<90mL/min/1.73 m2)

Autoimmune disease (e.g. systemic lupus erythematous, antiphospholipid syndrome)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months for each patient (from recruitment until 6 weeks postpartum)

Awards & highlights

ASAPP Trial Summary

This trial is testing whether a higher dose of aspirin can help prevent preeclampsia, a dangerous complication of pregnancy.

Who is the study for?

This trial is for pregnant women over 18, under 16 weeks gestation with a history of preeclampsia or risk factors like chronic hypertension, diabetes, renal disease, or autoimmune disorders. It's not for those allergic to aspirin, at high bleeding risk, with major fetal malformations on ultrasound, or planning pregnancy termination.Check my eligibility

What is being tested?

The study compares the effectiveness of two low-dose aspirin regimens (81mg vs. 162mg daily) in preventing severe or preterm preeclampsia in high-risk pregnant women. Participants will be randomly assigned to one of the dosages from a single center.See study design

What are the potential side effects?

Aspirin may cause side effects such as gastrointestinal issues (like stomach pain and heartburn), increased bleeding tendency especially during delivery if taken close to labor onset, and potential allergic reactions.

ASAPP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have kidney issues with protein in my urine or low kidney function.

Select...

I have an autoimmune disease like lupus.

Select...

I am pregnant, under 16 weeks, and at risk for preeclampsia.

Select...

I have type 1 or type 2 diabetes.

ASAPP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months for each patient (from recruitment until 6 weeks postpartum)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months for each patient (from recruitment until 6 weeks postpartum)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for each patient (from recruitment until 6 weeks postpartum) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of preeclampsia with severe features

Incidence of preterm (<37 weeks) preeclampsia

Secondary outcome measures

Aspirin adherence

Aspirin compliance

Maternal and Fetal Outcomes

+1 more

Other outcome measures

Pre-Eclampsia

ASAPP Trial Design

2Treatment groups

Active Control

Group I: 162mg ASAActive Control1 Intervention

Patients in Arm 2, will be instructed to take two tablets simultaneously orally once per day.

Group II: 81mg ASAActive Control1 Intervention

Patients in Arm 1, will be instructed to take one tablet of 81mg aspirin per day.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,128 Total Patients Enrolled

Line Malha, MD, MSPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

Acetylsalicylic Acid (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04070573 — Phase 3

Prophylaxis of Preeclampsia Research Study Groups: 162mg ASA, 81mg ASA

Prophylaxis of Preeclampsia Clinical Trial 2023: Acetylsalicylic Acid Highlights & Side Effects. Trial Name: NCT04070573 — Phase 3

Acetylsalicylic Acid (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04070573 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals of ____ years old or younger being accepted for this research project?

"This study's requirements for participants state that they must be between 18-60 years old. There are 27 studies available for patients who are not yet adults and 216 trials specifically designed for seniors."

Answered by AI

For what medical purposes is 162mg ASA typically prescribed?

"A 162mg ASA dosage is frequently used to treat percutaneous coronary intervention (pci) but can also help with other conditions like dental procedures, inflammation and neck pain."

Answered by AI

What are the goals that this trial is hoping to achieve?

"This clinical trial's primary outcome will be evaluated over a 9-month period for each patient, from recruitment to 6 weeks postpartum. The primary outcome is the incidence of preeclampsia with severe features. Secondary outcomes include aspirin adherence (defined as pregnant women's adherence to 81mg or 162mg of daily low-dose aspirin, using a validated Simplified Medication Adherence Questionnaire), time-to-event for preeclampsia and gestational age at onset of PE (comparing the time it takes for development of preeclampsia in women treated with 81mg vs162mg of aspirin per day,"

Answered by AI

What dosage of aspirin has the FDA cleared for use?

"There is evidence from previous trials to support the efficacy of 162mg ASA, so it received a score of 3."

Answered by AI

How do I qualify to participate in this experiment?

"400 expectant mothers suffering from pre-eclampsia will be recruited for this study, provided they are between 18-60 years old. Eligibility criteria for participants include: a history of PE in a past pregnancy, carrying more than one fetus, or an autoimmune disease such as lupus erythematous or antiphospholipid syndrome."

Answered by AI

Are there any remaining vacancies for patients in this clinical trial?

"This clinical trial is actively looking for participants, as reported on clinicaltrials.gov. The original posting date was 10/21/2019, and the most recent update was 12/9/2021."

Answered by AI

Are there other similar clinical trials to this one?

"162mg ASA has been under research since 2002 when the first trial was conducted by Sanofi. 413 patients were involved in this initial study which led to Phase 3 drug approval for 162mg ASA. Currently, there are 181 active studies being conducted for162mg ASA across 1451 cities and 61 countries."

Answered by AI

Recent research and studies

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal

Gprobe

Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.

New England Journal of MedicineJournal

Aspirin Versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia

Rolnik, Daniel L., David Wright, Liona C. Poon, Neil O’Gorman, Argyro Syngelaki, Catalina de Paco Matallana, Ranjit Akolekar, et al.. 2017. “Aspirin Versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1704559.

Acta Obstetricia et Gynecologica ScandinavicaJournal

Prostacyclin, Thromboxane A2 and the Effect of Low-dose ASA in Pregnancies at High Risk for Hypertensive Disorders

Vainio, Merja, Asko Riutta, Anna-Maija Koivisto, and Johanna Mäenpää. 2004. “Prostacyclin, Thromboxane A2 and the Effect of Low-dose ASA in Pregnancies at High Risk for Hypertensive Disorders”. Acta Obstetricia Et Gynecologica Scandinavica. Wiley. doi:10.1111/j.0001-6349.2004.00396.x.

American Journal of Obstetrics and GynecologyJournal