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Anticoagulant

LMWH + Aspirin vs. LMWH Alone for Preventing Blood Clots Post-partum (LEAP Trial)

N/A

Recruiting

Led By Evang Vlachodimitropoulou Koumoutsea, MBBS

Research Sponsored by Mount Sinai Hospital, Canada

Eligibility Criteria Checklist

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

Must have

> 18 years of age.

Personal history of unprovoked VTE prior to pregnancy or hormone associated VTE and not prescribed therapeutic anticoagulation

Must not have

Patients with bleeding disorders

Active bleeding at any site, excluding physiological vaginal bleeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether prophylactic anticoagulation with 3 weeks of LMWH followed by 3 weeks of Aspirin is better than the standard of care of prophylactic LMWH for 6 weeks at moderate to high risk of developing VTE.

Who is the study for?

This trial is for postpartum women at moderate to high risk of blood clots, with a personal or family history of unprovoked VTE or hormone-associated VTE without current anticoagulation therapy. It's also for those with certain genetic clotting disorders. Women over 18 can join unless they have severe hypertension, allergies to LMWH, bleeding disorders, need therapeutic LMWH already, active bleeding (other than normal vaginal bleeding), or contraindications to aspirin.

What is being tested?

The study compares two treatments after childbirth to prevent blood clots: one group receives low molecular weight heparin (LMWH) for six weeks; the other gets LMWH for three weeks followed by low-dose aspirin for another three weeks. Participants are randomly assigned to either treatment.

What are the potential side effects?

Possible side effects include bleeding complications, allergic reactions to heparin or aspirin such as rashes and hives, and less commonly heparin-induced thrombocytopenia (a drop in platelet count leading to increased risk of clotting). Aspirin may cause gastrointestinal issues like ulcers.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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I have had blood clots without a clear cause or due to hormones and am not on blood thinners.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding disorder.

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I do not have any active bleeding except for normal menstrual bleeding.

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I have had very high blood pressure during or after my pregnancy.

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I am allergic to or cannot take LMWH.

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I need LMWH for an existing health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to Prescription

Rates of contamination

Secondary study objectives

Anticoagulation Satisfaction Assessment using the Duke Anticoagulation Satisfaction Scale (DASS)

Bleeding assessment six weeks following delivery

VTE event rate

Awards & Highlights

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: Prophylactic Low Molecular Weight Heparin (LMWH) + Low Dose AspirinExperimental Treatment1 Intervention

Prophylactic LMWH for 3 weeks followed by low dose Aspirin for 3 weeks.

Group II: Prophylactic Low Molecular Weight Heparin (LMWH)Active Control1 Intervention

Prophylactic LMWH for 6 weeks postpartum

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor

203 Previous Clinical Trials

69,198 Total Patients Enrolled

1 Trials studying Deep Vein Thrombosis

2,000 Patients Enrolled for Deep Vein Thrombosis

Evang Vlachodimitropoulou Koumoutsea, MBBSPrincipal InvestigatorDepartment of Obstetrics and Gynecology, University of Toronto, Mount Sinai Hospital

Nadine Shehata, MDPrincipal InvestigatorDepartment of Medicine/IHPME, University of Toronto, Division of Hematology, Mount Sinai Hospital

3 Previous Clinical Trials

6,676 Total Patients Enrolled

Evanglia Vlachodimitropoulou Koumoutsea, MBBSPrincipal InvestigatorDepartment of Obstetrics and Gynecology, University of Toronto, Mount Sinai Hospital