Clinical Trial: AntiPhospholipid Syndrome Low-molecular-weight Heparin Pregnancy Loss Evaluation: The Pilot Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.


Detailed Summary:

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.


Sponsor: Ottawa Hospital Research Institute

Current Primary Outcome: Feasibility [ Time Frame: 24 months ]

The primary feasibility outcome of the pilot trial is the mean recruitment rate per center per month.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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).
  • Consent [ Time Frame: 24 months ]
    Proportion of eligible subjects who provide consent.
  • Withdrawals/Loss to Follow-up [ Time Frame: 24 months ]
    Proportion of withdrawals/loss to follow-up among randomized patients.
  • Crossover Rate [ Time Frame: 52 weeks ]
    Crossover rate between standard of care and experimental study arms.
  • Study Drug Compliance [ Time Frame: 52 weeks ]
    Level of compliance with study drug through patient recall and patient medication diary.
  • Non-consent [ Time Frame: 24 months ]
    Reasons for physician and patient non-consent.


Original Secondary Outcome: Same as current

Information By: Ottawa Hospital Research Institute

Dates:
Date Received: February 21, 2017
Date Started: April 2017
Date Completion: July 2019
Last Updated: March 28, 2017
Last Verified: March 2017