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Venous ThromboembolismLEAPNCT05058924

Low Molecular Weight hEparin vs. Aspirin Post-partum

A study testing Prophylactic low molecular weight heparin and Low molecular weight heparin and low-dose aspirin in people with Venous Thromboembolism, run by Mount Sinai Hospital, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Venous Thromboembolism
What is being tested?
Prophylactic low molecular weight heparin and Low molecular weight heparin and low-dose aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
29 Aug 2021to 1 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Prophylactic low molecular weight heparin, Low molecular weight heparin and low-dose aspirin
Keywords
Postpartum, Prophylaxis, LMWH
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prophylactic low molecular weight heparinDrug

    Also called LMWH

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

  • Low molecular weight heparin and low-dose aspirinDrug

    Also called LMWH, ASA

    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.

Study groups in NCT05058924
Study groupRoleWhat they receive
Prophylactic Low Molecular Weight Heparin (LMWH)Active comparatorProphylactic LMWH for 6 weeks postpartum
Receives: Drug: Prophylactic low molecular weight heparin
Prophylactic Low Molecular Weight Heparin (LMWH) + Low Dose AspirinExperimentalProphylactic LMWH for 3 weeks followed by low dose Aspirin for 3 weeks.
Receives: Drug: Low molecular weight heparin and low-dose aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Enrollment Rate

    Measured: 1 year

  2. Consent Rate

    Measured: 1 year

  3. Adherence to Prescription

    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).

    Measured: 6 weeks

  4. Withdrawal of consent rate

    Measured: 1 year

  5. Rates of contamination

    List of the concurrent medication will be gathered on 3 week follow up, 6 week follow up and early discontinuation (before 6 weeks).

    Measured: 6 weeks

Secondary outcomes (3)

  1. VTE event rate

    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.

    Measured: 3 months

  2. Bleeding assessment six weeks following delivery

    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)

    Measured: 6 weeks

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

    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

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2021
  2. Study start29 Aug 2021
  3. Primary completion29 Feb 2024
  4. Study completion1 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single Center pilot feasibility RCT
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05058924
Sponsor's protocol ID
20-0275A
Acronym
LEAP
Status last verified
May 2023
First submitted
25 Aug 2021
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Matharu GS, Kunutsor SK, Judge A, Blom AW, Whitehouse MR. Clinical Effectiveness and Safety of Aspirin for Venous Thromboembolism Prophylaxis After Total Hip and Knee Replacement: A Systematic Review and Meta-analysis of Randomized Clinical Trials. JAMA Intern Med. 2020 Mar 1;180(3):376-384. doi: 10.1001/jamainternmed.2019.6108.

    PubMed 32011647

  • Bates SM, Rajasekhar A, Middeldorp S, McLintock C, Rodger MA, James AH, Vazquez SR, Greer IA, Riva JJ, Bhatt M, Schwab N, Barrett D, LaHaye A, Rochwerg B. American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy. Blood Adv. 2018 Nov 27;2(22):3317-3359. doi: 10.1182/bloodadvances.2018024802.

    PubMed 30482767

  • Samsa G, Matchar DB, Dolor RJ, Wiklund I, Hedner E, Wygant G, Hauch O, Marple CB, Edwards R. A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation. Health Qual Life Outcomes. 2004 May 6;2:22. doi: 10.1186/1477-7525-2-22.

    PubMed 15132746

  • Rodeghiero F, Tosetto A, Abshire T, Arnold DM, Coller B, James P, Neunert C, Lillicrap D; ISTH/SSC joint VWF and Perinatal/Pediatric Hemostasis Subcommittees Working Group. ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders. J Thromb Haemost. 2010 Sep;8(9):2063-5. doi: 10.1111/j.1538-7836.2010.03975.x. No abstract available.

    PubMed 20626619

  • Schulman S, Angeras U, Bergqvist D, Eriksson B, Lassen MR, Fisher W; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost. 2010 Jan;8(1):202-4. doi: 10.1111/j.1538-7836.2009.03678.x. Epub 2009 Oct 30.

    PubMed 19878532

  • Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.

    PubMed 15842354

  • Vlachodimitropoulou E, Malinowski K, Kaplovitch E, Carrier M, Shehata N. Low-molecular-weight heparin vs aspirin postpartum (LEAP): a single-center pilot randomized control trial. Blood Vessel Thromb Hemost. 2025 Sep 10;2(4):100106. doi: 10.1016/j.bvth.2025.100106. eCollection 2025 Nov.

    PubMed 41280308

Questions about this trial

What is this clinical trial studying?

A study testing Prophylactic low molecular weight heparin and Low molecular weight heparin and low-dose aspirin in people with Venous Thromboembolism, run by Mount Sinai Hospital, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment Rate (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05058924, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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