Low Molecular Weight hEparin vs. Aspirin Post-partum (LEAP)

January 22, 2024 updated by: Mount Sinai Hospital, Canada
This is single centre pilot, randomized controlled trial assessing postpartum prophylactic anticoagulation with 3 weeks of LMWH followed by 3 weeks of Aspirin compared to standard of care of prophylactic LMWH for 6 weeks at moderate to high risk of developing VTE.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A single centre pilot, randomized controlled trial assessing postpartum prophylactic anticoagulation with 3 weeks of LMWH followed by 3 weeks of Aspirin compared to standard of care of prophylactic LMWH for 6 weeks for women at moderate to high risk of developing VTE to determine feasibility of conducting a large non inferiority trial using the same regimens.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z5
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
        • Principal Investigator:
          • Nadine Shehata, MD
        • Sub-Investigator:
          • Evangelia Vlachodimitropoulou, MD
        • Sub-Investigator:
          • Kellie Murphy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Personal history of unprovoked VTE prior to pregnancy or hormone associated VTE and not prescribed therapeutic anticoagulation or
  2. Family history (1st degree relative) of VTE and antithrombin deficiency, protein C or protein S deficiency or
  3. Combined thrombophilia or homozygous for the factor V Leiden mutation or prothrombin gene mutation, and family history of VTE (1st degree relative) and
  4. > 18 years of age.

Exclusion Criteria:

  1. Pre-existing indication for therapeutic LMWH

  2. Contraindication to ASA:

    1. Known ASA allergy
    2. Documented history of gastrointestinal ulcer
    3. Known platelet count < 50x10^9/L at any time during the current pregnancy or postpartum
  3. Contraindication to LMWH, e.g. known allergy
  4. Active bleeding at any site, excluding physiological vaginal bleeding
  5. Patients with bleeding disorders
  6. Known severe hypertension (SBP >200mm/hg and/or DBP >120mm/hg) during the current pregnancy or postpartum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prophylactic Low Molecular Weight Heparin (LMWH)
Prophylactic LMWH for 6 weeks postpartum
Drug: Prophylactic low molecular weight heparin
Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight <100 kg for 6 weeks.
Other Names:
  • LMWH
Experimental: Prophylactic Low Molecular Weight Heparin (LMWH) + Low Dose Aspirin
Prophylactic LMWH for 3 weeks followed by low dose Aspirin for 3 weeks.
Drug: Low molecular weight heparin and low-dose aspirin
Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight <100 kg for three weeks followed by ASA 81 mg orally daily for three weeks.
Other Names:
  • ASA
  • LMWH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment Rate
Time Frame: 1 year
1 year
Consent Rate
Time Frame: 1 year
1 year
Adherence to Prescription
Time Frame: 6 weeks
Utilization of co-interventions for both: control group (6 week of Low Molecular Weight Heparin) or Treatment group (3 week of low molecular weight Heparin and 3 week of low dose aspirin).
6 weeks
Withdrawal of consent rate
Time Frame: 1 year
1 year
Rates of contamination
Time Frame: 6 weeks
List of the concurrent medication will be gathered on 3 week follow up, 6 week follow up and early discontinuation (before 6 weeks).
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VTE event rate
Time Frame: 3 months
VTE must be confirmed either by Doppler ultrasound or V/Q scan or computer tomography (CT). Imaging will not be performed on all patients, only those with symptoms of VTE event. Event rate of VTE will be calculated by number of VTE events by Total days in this study. This number of VTE event is collected during 3 week follow up, 6 week follow up, 3 months follow-up and on early discontinuation date (before 3 months follow up). At the end of the study (after 3 month), the total VTE event rate is calculated.
3 months
Bleeding assessment six weeks following delivery
Time Frame: 6 weeks
According to the International Society on Thrombosis and Hemostasis (ISTH) scoring system. The bleeding assessments are collected on 3 week phone call and 6 week phone call or early discontinuation visit (before 6 week follow up)
6 weeks
Anticoagulation Satisfaction Assessment using the Duke Anticoagulation Satisfaction Scale (DASS)
Time Frame: 6 weeks
The maximum value would be 65, indicating the worst quality of life. Minimum value would be 13, indicating best quality of life. This satisfaction assessment would be collected on dosing (day 1), 3 week follow up, 6 week follow up and if early discontinuation.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Sinai Hospital, Canada

Investigators

  • Principal Investigator: Nadine Shehata, MD, Department of Medicine/IHPME, University of Toronto, Division of Hematology, Mount Sinai Hospital
  • Principal Investigator: Evanglia Vlachodimitropoulou Koumoutsea, MBBS, Department of Obstetrics and Gynecology, University of Toronto, Mount Sinai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2021

Primary Completion (Estimated)

February 29, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 28, 2021

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-0275A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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