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AntiPhospholipid Syndrome Low-molecular-weight Heparin Pregnancy Loss Evaluation: The Pilot Study (APPLE)

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ClinicalTrials.gov Identifier: NCT03100123
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:

The APPLE pilot trial is a feasibility study that is a multicentre, open-label, randomized controlled trial. Pregnant women with antiphospholipid syndrome (APS) and a history of late (≥10 weeks gestation) or recurrent early (2 <10 weeks) pregnancy loss will be recruited.

Eligible and consenting subjects will be assigned to one of two study arms: open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin (ASA) daily until delivery, or open-label low-dose aspirin daily from randomization until delivery.


Condition or disease Intervention/treatment Phase
Antiphospholipid Syndrome in Pregnancy Pregnancy Loss Drug: Aspirin 81 mg Drug: Low-molecular-weight heparin Early Phase 1

Detailed Description:

The purpose of this pilot trial is to determine the feasibility of conducting a multicenter randomized full trial evaluating antepartum prophylaxis with ASA versus LMWH/ASA in women with confirmed APS and a history of late or recurrent early pregnancy loss.

Given the large sample size needed to adequately power a large multicenter trial that assesses the efficacy of ASA alone versus LMWH/ASA, the investigators first need to determine if it is possible to meet minimum recruitment rates needed for a full multicenter trial. If the pilot feasibility trial is successful, then the secondary outcomes collected will be used in the analysis of the full multicenter trial.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible and consenting subjects will be assigned to one of two study arms. Randomization is stratified by 'high-risk' or 'non-high risk' laboratory criteria and the timing of pregnancy loss (late loss or no late loss).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin Versus Low-molecular-weight Heparin (LMWH) and Aspirin in Women With Antiphospholipid Syndrome and Pregnancy Loss
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : November 6, 2019
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Active Comparator: Standard of Care Arm
Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery.
Drug: Low-molecular-weight heparin
The LMWH regime will be at the discretion of the treating physician, with a suggested regime as follows: tinzaparin 4,500 IU sc daily until 20 weeks gestation, and then 4,500 IU sc twice daily until 37 weeks gestation.
Other Names:
  • Tinzaparin
  • Dalteparin
  • Enoxaparin
  • LMWH

Experimental: Experimental Arm
Open-label low-dose Aspirin 81 mg daily from randomization until delivery.
Drug: Aspirin 81 mg
Aspirin 81 mg po daily in tablet form.
Other Name: Acetylsalicylic Acid




Primary Outcome Measures :
  1. Feasibility [ Time Frame: 24 months ]
    The primary feasibility outcome of the pilot trial is the mean recruitment rate per center per month.


Secondary Outcome Measures :
  1. Essential Documents [ Time Frame: 18 months ]
    Proportion of sites requiring >18 months to obtain all required approvals/contracts from time of delivery of all study documents.

  2. Eligibility [ Time Frame: 24 months ]
    Proportion of screened patients who meet eligibility criteria (i.e. patients who meet inclusion criteria and are also eligible based on exclusion criteria).

  3. Consent [ Time Frame: 24 months ]
    Proportion of eligible subjects who provide consent.

  4. Withdrawals/Loss to Follow-up [ Time Frame: 24 months ]
    Proportion of withdrawals/loss to follow-up among randomized patients.

  5. Crossover Rate [ Time Frame: 52 weeks ]
    Crossover rate between standard of care and experimental study arms.

  6. Study Drug Compliance [ Time Frame: 52 weeks ]
    Level of compliance with study drug through patient recall and patient medication diary.

  7. Non-consent [ Time Frame: 24 months ]
    Reasons for physician and patient non-consent.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed pregnancy;
  • 18 years or older;
  • Two or more unexplained pregnancy loss before the 10th week of gestation, AND/OR one or more unexplained pregnancy loss at or beyond the 10th week of gestation;
  • One or more APS laboratory criteria present, according to the revised Sapporo criteria;

Exclusion Criteria:

  • Greater than 11 weeks +6 days gestational age at time of randomization;
  • Indication(s) for prophylactic or therapeutic-dose anticoagulation;
  • Contraindication to heparin or aspirin;
  • Received 7 or more doses of LMWH;
  • Previous participation in the trial;
  • Geographic inaccessibility;
  • Refused consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100123


Contacts
Contact: Leslie Skeith, MD 613-737-8899 ext 71068 lskeith@toh.ca
Contact: Veronica Whitham, BSc 613-737-8899 ext 71068 vwhitham@ohri.ca

Locations
Canada, Ontario
McMaster University Medical Centre Not yet recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Shannon Bates, M.D.    905 521-2100 ext 73928    batesm@mcmaster.ca   
Contact: Shannon Dodds       doddss@mcmaster.ca   
Principal Investigator: Shannon Bates, MD         
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Marc Rodger, MD    613-737-8899 ext 74641    mrodger@toh.ca   
Contact: Veronica Whitham, BSc    613-737-8899 ext 71068    vwhitham@ohri.ca   
Principal Investigator: Marc Rodger, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Marc Rodger, MD Ottawa Hospital Research Institute
Principal Investigator: Leslie Skeith, MD Ottawa Hospital Research Institute

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03100123     History of Changes
Other Study ID Numbers: CTO 0807
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Abortion, Spontaneous
Fetal Death
Antiphospholipid Syndrome
Disease
Pathologic Processes
Pregnancy Complications
Death
Autoimmune Diseases
Immune System Diseases
Aspirin
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin
Tinzaparin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors