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Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL

NCT06468202 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10742

Last updated 2026-05-04

No results posted yet for this study

Summary

The overall goal of this large, pragmatic, comparative effectiveness trial is to test the hypothesis that among at-risk individuals, 162 mg/day aspirin is superior to 81 mg/day in preventing Hypertensive disorders of pregnancy (HDP), and that there are multiple factors associated with adherence with aspirin therapy that will be important to identify to enable optimal implementation of study findings and population-level benefits.

Conditions

  • Hypertensive Disorders of Pregnancy
  • Preeclampsia
  • Gestational Hypertension

Interventions

DRUG

Aspirin 81 mg

Participants will be assigned to 81mg Aspirin

DRUG

Aspirin 162 mg

Participants will be assigned to 162mg Aspirin

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Northwestern University

    collaborator OTHER

  • Preeclampsia Foundation

    collaborator OTHER

  • Ohio State University

    lead OTHER

Principal Investigators

  • Maged Costantine, MD, MBA · Ohio State University

  • Denise Sholtens, PhD · Northwestern University Data Analysis and Coordinating Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-18
Primary Completion
2029-01-01
Completion
2030-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06468202 on ClinicalTrials.gov