Postpartum Aspirin for Blood Clots

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byMarc Rodger, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Calgary

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goal of the PARTUM trial is to determine if taking low-dose aspirin daily for 6 weeks after delivery is similar (non-inferior) to usual care low-molecular-weight heparin injections to prevent venous thromboembolism (VTE: blood clots in the legs or lungs) for postpartum individuals with VTE risk factors.

Eligibility Criteria

The PARTUM trial is for individuals who have recently given birth and are at risk of developing blood clots. Participants must be in the postpartum period and meet certain criteria that put them at higher risk for venous thromboembolism.

Inclusion Criteria

I have had a clot in a vein near the surface of my body.

My BMI was 30 or higher before I got pregnant.

Preeclampsia

+8 more

Exclusion Criteria

More than 48 hours since delivery at the time of randomization

I have received more than one dose of LMWH since giving birth.

Unable or declined consent

+5 more

Participant Groups

This study tests if taking low-dose aspirin daily for six weeks after giving birth can prevent blood clots as effectively as the standard treatment with low-molecular-weight heparin injections.

2Treatment groups

Experimental Treatment

Active Control

Group I: AspirinExperimental Treatment1 Intervention

Low-dose aspirin (75-100 mg) once daily for 6 weeks.

Group II: Low-molecular-weight heparinActive Control1 Intervention

Site-specific low-molecular-weight heparin regimen as prescribed by the treating physician.

Aspirin is already approved in European Union, United States, Canada, China for the following indications:

🇪🇺 Approved in European Union as Aspirin for: