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Completed

NCT Number: NCT05058924

Low Molecular Weight hEparin vs. Aspirin Post-partum

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1Z5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pre-existing indication for therapeutic LMWH
  • Contraindication to ASA:
  • Known ASA allergy
  • Documented history of gastrointestinal ulcer
  • Known platelet count < 50x10^9/L at any time during the current pregnancy or postpartum
  • Contraindication to LMWH, e.g. known allergy
  • Active bleeding at any site, excluding physiological vaginal bleeding
  • Patients with bleeding disorders
  • Known severe hypertension (SBP >200mm/hg and/or DBP >120mm/hg) during the current pregnancy or postpartum

Treatment and study plan

Prophylactic low molecular weight heparin

Drug

Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight <100 kg for 6 weeks.

Other names: LMWH

Low molecular weight heparin and low-dose aspirin

Drug

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: LMWH, ASA

Primary outcomes

  1. Enrollment Rate

    Time frame: 1 year

  2. Consent Rate

    Time frame: 1 year

  3. 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).

  4. Withdrawal of consent rate

    Time frame: 1 year

  5. 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).

Secondary outcomes

  1. 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.

  2. 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)

  3. Anticoagulation Satisfaction Assessment using the Perception of Anticoagulant Treatment Questionnaire (PACT-Q©) Scale

    Time frame: 6 weeks

    Treatment expectations: score 1-5, higher score =higher expectations of treatment Convenience: score 1-100, reverse score, higher score= more convenient Anticoagulation treatment satisfaction: score 1-100, higher score=higher patient satisfaction

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Registry information

Acronym: LEAP

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2021
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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