NCT03100123: APPLE

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

Terminated EARLY_PHASE1 Results posted Last updated 8 April 2020

What this trial tests

EARLY_PHASE1 trial testing Aspirin 81 mg in Antiphospholipid Syndrome in Pregnancy in 1 participant. Terminated before completion.

Timeline

6 November 2017

Primary endpoint
7 October 2019

7 October 2019

Quick facts

Lead sponsor	Ottawa Hospital Research Institute
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	6 November 2017
Primary completion	7 October 2019
Estimated completion	7 October 2019
Sites	1 location across Canada

Drugs / interventions tested

• Aspirin 81 mg — full drug profile →
• Low-molecular-weight heparin

Conditions studied

• Antiphospholipid Syndrome in Pregnancy — all drugs for Antiphospholipid Syndrome in Pregnancy →
• Pregnancy Loss — all drugs for Pregnancy Loss →

Sponsor

Ottawa Hospital Research Institute

Who can join

18 and older, female only, with Antiphospholipid Syndrome in Pregnancy or Pregnancy Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Study Feasibility: Mean Recruitment Rate Per Center Per Month Primary · 24 months

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

Group	Value	95% CI
Experimental Arm	1

Essential Documents Secondary · 18 months

Proportion of sites requiring \>18 months to obtain all required approvals/contracts from time of delivery of all study documents.

Group	Value	95% CI
Approval Timeline	1

Eligibility Secondary · 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).

Group	Value	95% CI
Screened Patients Who Met Eligibility Criteria	4

Consent Secondary · 24 months

Proportion of eligible subjects who provide consent.

Group	Value	95% CI
Consented Eligible Patients	1

Withdrawals/Loss to Follow-up Secondary · 24 months

Proportion of withdrawals/loss to follow-up among randomized patients.

Group	Value	95% CI
Withdrawal/Lost to Follow-up	0

Crossover Rate Secondary · 52 weeks

Crossover rate between standard of care and experimental study arms.

Group	Value	95% CI
Crossover Rate	0

Study Drug Compliance Secondary · 52 weeks

Level of compliance with study drug through patient recall and patient medication diary.

Group	Value	95% CI
Standard of Care Arm	0
Experimental Arm	1

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss.
   Hamulyák EN, Scheres LJ, Marijnen MC, Goddijn M, et al · · 2020 · cited 72× · PMID 32358837 · DOI 10.1002/14651858.cd012852.pub2
2. Antiplatelet and anticoagulant agents for primary prevention of thrombosis in individuals with antiphospholipid antibodies.
   Bala MM, Paszek E, Lesniak W, Wloch-Kopec D, et al · · 2018 · cited 27× · PMID 30004572 · DOI 10.1002/14651858.cd012534.pub2
3. Care prior to and during subsequent pregnancies following stillbirth for improving outcomes.
   Wojcieszek AM, Shepherd E, Middleton P, Lassi ZS, et al · · 2018 · cited 23× · PMID 30556599 · DOI 10.1002/14651858.cd012203.pub2