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Antiplatelet Agent

Postpartum Aspirin for Blood Clots

Phase 3
Waitlist Available
Led By Leslie Skeith, MD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previous clinical history of superficial vein thrombosis
Pre-pregnancy BMI ≥30 kg/m²
Must not have
Received more than 1 dose of LMWH since delivery
Active bleeding, excluding normal vaginal bleeding, at the time of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 weeks and at 90 days
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

"This trial aims to see if taking a low dose of aspirin daily for 6 weeks after giving birth is as effective as receiving regular injections of a blood thinner to prevent blood clots in the legs

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include bleeding risks associated with aspirin, such as bruising or nosebleeds, and potential injection site reactions or allergies from heparin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a clot in a vein near the surface of my body.
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My BMI was 30 or higher before I got pregnant.
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I have a genetic condition that affects blood clotting.
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I lost 1000 mL or more of blood after giving birth.
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I was on bed rest for more than a week during my pregnancy.
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I had an infection with fever and high white blood cells after giving birth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received more than one dose of LMWH since giving birth.
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I do not have any unusual bleeding except for normal periods.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 weeks and at 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 weeks and at 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Symptomatic VTE
Secondary study objectives
Clinically relevant non-major bleeding
Distal deep vein thrombosis
Heparin-induced thrombocytopenia
+7 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin
2014
Completed Phase 4
~55580

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
809 Previous Clinical Trials
877,578 Total Patients Enrolled
3 Trials studying Venous Thromboembolism
1,095 Patients Enrolled for Venous Thromboembolism
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,509,268 Total Patients Enrolled
15 Trials studying Venous Thromboembolism
78,659 Patients Enrolled for Venous Thromboembolism
Leslie Skeith, MDPrincipal InvestigatorUniversity of Calgary
3 Previous Clinical Trials
1,083 Total Patients Enrolled
2 Trials studying Venous Thromboembolism
1,082 Patients Enrolled for Venous Thromboembolism
~5870 spots leftby Aug 2030
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