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

NCT03100123 | Terminated Early Phase 1 Results DMC

• 1 other identifier: CTO 0807
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Antiphospholipid Syndrome in Pregnancy; Pregnancy Loss

Outcome Measures

Primary Outcomes (1)

• Study Feasibility: Mean Recruitment Rate Per Center Per Month

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

  24 months

Secondary Outcomes (6)

• Essential Documents

  18 months

• Eligibility

  24 months

• Consent

  24 months

• Withdrawals/Loss to Follow-up

  24 months

• Crossover Rate

  52 weeks

Study Arms (2)

Standard of Care Arm

ACTIVE COMPARATOR

Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery.

Drug: Low-molecular-weight heparin

Experimental Arm

EXPERIMENTAL

Open-label low-dose Aspirin 81 mg daily from randomization until delivery.

Drug: Aspirin 81 mg

Interventions

Aspirin 81 mg DRUG

Aspirin 81 mg po daily in tablet form.

Also known as: Acetylsalicylic Acid

Experimental Arm

Low-molecular-weight heparin DRUG

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.

Also known as: Tinzaparin, Dalteparin, Enoxaparin, LMWH

Standard of Care Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed pregnancy;
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

Related Publications (1)

• Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2.

  PMID: 32358837 DERIVED

MeSH Terms

Interventions

Aspirin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Enoxaparin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Leslie Skeith
• Organization: Ottawa Hospital Research Institute

laskeith@ucalgary.ca

403-944-5246

Study Officials

• Marc Rodger, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Leslie Skeith, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: April 4, 2017
• Study Start: November 6, 2017
• Primary Completion: October 7, 2019
• Study Completion: October 7, 2019
• Last Updated: April 8, 2020
• Results First Posted: April 8, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)