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Anticoagulant

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

N/A

Recruiting

Led By Evanglia 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

Combined thrombophilia or homozygous for the factor V Leiden mutation or prothrombin gene mutation, and family history of VTE (1st degree relative)

> 18 years of age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

LEAP Trial 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.Check my eligibility

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.See study design

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.

LEAP Trial Eligibility Criteria

Inclusion Criteria

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

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I have a genetic blood clotting disorder and a family history of blood clots.

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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.

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My close family has a history of blood clot disorders.

LEAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adherence to Prescription

Consent Rate

Enrollment Rate

+2 more

Secondary outcome measures

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

Bleeding assessment six weeks following delivery

VTE event rate

LEAP 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor

196 Previous Clinical Trials

67,558 Total Patients Enrolled

1 Trials studying Deep Vein Thrombosis

2,000 Patients Enrolled for Deep Vein Thrombosis

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

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

Media Library

Low molecular weight heparin (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT05058924 — N/A

Deep Vein Thrombosis Research Study Groups: Prophylactic Low Molecular Weight Heparin (LMWH), Prophylactic Low Molecular Weight Heparin (LMWH) + Low Dose Aspirin

Deep Vein Thrombosis Clinical Trial 2023: Low molecular weight heparin Highlights & Side Effects. Trial Name: NCT05058924 — N/A

Low molecular weight heparin (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05058924 — N/A

Frequently Asked Questions

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

How many individuals have enrolled in this experiment?

"Affirmative. According to the info posted on clinicaltrials.gov, this research project is actively searching for volunteers and has been since August 29th 2021 when it was first published. This study requires 50 participants from one site and was most recently updated on September 15th 2022."

Answered by AI

What maladies typically benefit from the joint administration of low molecular weight heparin and low-dose aspirin?

"Low molecular weight heparin and low-dose aspirin are traditionally used to alleviate pain, but they can also mitigate the risk of peripheral arterial embolism, myocardial infarction, and catarrh."

Answered by AI

Is enrollment for this experiment still available to participants?

"Affirmative. According to the information from clinicaltrials.gov, this medical investigation is still enrolling participants. This trial was first made available on August 29th 2021, and has been updated as recently as September 15th 2022. 50 patients will be admitted at one site for participation in the study."

Answered by AI

What has been the outcome of prior investigations into Low molecular weight heparin and low-dose aspirin?

"Currently, 201 Low molecular weight heparin and low-dose aspirin studies are being conducted worldwide. Of those active trials, 60 have reached Phase 3 status. Although the majority of these experiments take place in Shanghai, there are 4156 sites executing research for this treatment."

Answered by AI

Is this the inaugural implementation of such a trial?

"As of today, there are 201 active clinical trials involving Low molecular weight heparin and low-dose aspirin. These research projects span 60 countries and 1469 cities around the world. Since Abbott sponsored the initial trial in 2005 - which included 15480 participants and concluded Phase 4 drug approval - 688 studies have been completed."

Answered by AI

Recent research and studies

Blood AdvancesJournal

American Society of Hematology 2018 Guidelines for Management of Venous Thromboembolism: Venous Thromboembolism in the Context of Pregnancy

Bates, Shannon M., Anita Rajasekhar, Saskia Middeldorp, Claire McLintock, Marc A. Rodger, Andra H. James, Sara R. Vazquez, et al.. 2018. “American Society of Hematology 2018 Guidelines for Management of Venous Thromboembolism: Venous Thromboembolism in the Context of Pregnancy”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2018024802.

Journal of Thrombosis and HaemostasisJournal

Definition of Major Bleeding in Clinical Investigations of Antihemostatic Medicinal Products in Surgical Patients

SCHULMAN, S., U. ANGERÅS, D. BERGQVIST, B. ERIKSSON, M. R. LASSEN, W. FISHER, and ON BEHALF OF THE SUBCOMMITTEE ON CONTROL OF ANTICOAGULATION OF THE SCIENTIFIC AND STANDARDIZATION COMMITTEE OF THE INTERNATIONAL SOCIETY ON THROMBOSIS AND HAEMOSTASIS. 2010. “Definition of Major Bleeding in Clinical Investigations of Antihemostatic Medicinal Products in Surgical Patients”. Journal of Thrombosis and Haemostasis. Wiley. doi:10.1111/j.1538-7836.2009.03678.x.

Health and Quality of Life OutcomesJournal

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Samsa, Greg, David B Matchar, Rowena J Dolor, Ingela Wiklund, Ewa Hedner, Gail Wygant, Ole Hauch, Cheryl Beadle Marple, and Roger Edwards. 2004. “[]”. Health and Quality of Life Outcomes. Springer Science and Business Media LLC. doi:10.1186/1477-7525-2-22.

JAMA Internal MedicineJournal