- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04153760
Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity (PARTUM)
A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin in Postpartum Women at Risk of Developing Venous Thromboembolism
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of the pilot PARTUM trial is to determine whether it is feasible to conduct a larger randomized controlled trial to determine whether low-dose aspirin is efficacious and safe at preventing postpartum venous thromboembolism (VTE) in women at increased risk of VTE, compared to placebo.
Given the large sample size needed to adequately power a large multicenter trial that assesses the efficacy of aspirin 81 mg versus placebo, the investigators first need to determine if it is possible to recruit enough women. If the pilot trial is successful and there are no major changes to the study design, then the secondary clinical outcomes collected in the pilot trial will be used in the analysis of the full multicenter trial.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Foothills Medical Centre
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3N1
- British Columbia Women's Hospital & Health Centre
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital - General Campus
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Toronto, Ontario, Canada, M5G 1Z5
- Mount Sinai Hospital
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Loire
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Saint-Étienne, Loire, France, 42270
- Centre Hospitalier Universitaire de Saint-Etienne
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Dublin, Ireland, D01 P5W9
- Rotunda hospital
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North Holland
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Amsterdam, North Holland, Netherlands, 1105
- The Amsterdam Medical Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria: Study inclusion criteria includes one (or more) first order criterion or two (or more) second order criteria. A patient is still eligible if they have multiple criteria met, at the discretion of the local investigator.
ONE (or more) First Order Criteria:
Known inherited thrombophilia diagnosed prior to enrolment:
i) Heterozygous factor V Leiden, OR ii) Heterozygous prothrombin gene variant, OR iii) Protein C deficiency, OR iv) Protein S deficiency
- Immobilization (90% of waking hours spent in bed) for ≥7 days anytime during the antepartum period
TWO (or more) Second Order Criteria:
- Postpartum infection
- Postpartum hemorrhage (>1000 mL of blood loss, regardless of delivery mode)
- Pre-pregnancy BMI ≥30 kg/m2
- Emergency or unplanned cesarean delivery
- Smoking ≥5 cigarettes/day before pregnancy
- Pre-eclampsia
- Current pregnancy ending in stillbirth (pregnancy loss >20 weeks gestation)
- Small-for-gestational-age infant (<3rd percentile adjusted for gestational age and sex).
- Previous history of superficial vein thrombosis
Exclusion Criteria:
- More than 48 hours since delivery
- Received more than 2 doses of low-molecular-weight heparin (LMWH) since delivery
Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by the local investigator. May include but is not limited to:
- Documented history of provoked or unprovoked VTE
- Mechanical heart valve(s)
- Known antiphospholipid syndrome
- Known high-risk inherited thrombophilia i) Antithrombin deficiency; ii) Homozygous factor V Leiden; iii) Homozygous prothrombin gene mutation; iv) Compound heterozygosity factor V Leiden and prothrombin gene mutation; v) More than one inherited thrombophilia
Need for postpartum aspirin as judged by the local investigator. May include but is not limited to:
- Documented history of myocardial infarction
- Documented history of ischemic stroke or transient ischemic attack (TIA)
Contraindication to aspirin including:
- History of known aspirin allergy
- Documented history of a gastrointestinal ulcer
- Known platelet count <50 x 109/L at any time during the current pregnancy or postpartum
- Active bleeding at any site, excluding normal vaginal bleeding, at the time of randomization
- Most recent known hemoglobin ≤70 g/L documented during the current pregnancy or postpartum
- Known severe hypertension (SBP >200mm/hg and/or DBP >120mm/hg) during the current pregnancy or postpartum
- <18 years of age
- Unable or refused consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Aspirin
Aspirin 81 mg daily for six weeks post-randomization (postpartum)
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Aspirin 81 mg p.o. daily
Other Names:
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Placebo Comparator: Placebo
Placebo daily for six weeks post-randomization (postpartum)
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Placebo p.o. daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment Rate
Time Frame: 6 months
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Mean recruitment rate per center per month
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Consent Rate
Time Frame: 6 months
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Proportion of eligible subjects who provide consent
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6 months
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Withdrawals/Loss to Follow-up
Time Frame: 9 months
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Proportion of withdrawals/loss to follow-up among participants
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9 months
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Study Drug Compliance
Time Frame: 6 months
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Level of compliance with study drug through participant recall and medication diary
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6 months
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Time Required to Obtain Site Institutional Approvals
Time Frame: 24 months
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Proportion of sites requiring >18 months to obtain all required approvals/contracts from time of delivery of all study documents.
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24 months
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VTE Event Rate
Time Frame: 6 months
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A more precise estimate of the VTE event rate
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6 months
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Bleeding Event Rate
Time Frame: 6 months
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A more precise estimate of the major and clinically relevant non-major bleeding event rate
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marc Rodger, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Principal Investigator: Leslie Skeith, MD, University of Calgary
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Embolism and Thrombosis
- Thromboembolism
- Venous Thromboembolism
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- REB19-1237
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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