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

Pregnancy Loss Clinical Trial

— APPLE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03100123
• Other study ID #: CTO 0807
• Status: Terminated
• Phase: Early Phase 1
• Start date: November 6, 2017
• Est. completion date: October 7, 2019

Study information

• Verified date: March 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 7, 2019
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Antiphospholipid Syndrome
• Antiphospholipid Syndrome in Pregnancy
• Fetal Death
• Pregnancy Loss
• Syndrome

Intervention

Drug:
• Aspirin 81 mg
Aspirin 81 mg po daily in tablet form.
• 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.

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Essential Documents	Proportion of sites requiring >18 months to obtain all required approvals/contracts from time of delivery of all study documents.	18 months
Secondary	Eligibility	Proportion of screened patients who meet eligibility criteria (i.e. patients who meet inclusion criteria and are also eligible based on exclusion criteria).	24 months
Secondary	Consent	Proportion of eligible subjects who provide consent.	24 months
Secondary	Withdrawals/Loss to Follow-up	Proportion of withdrawals/loss to follow-up among randomized patients.	24 months
Secondary	Crossover Rate	Crossover rate between standard of care and experimental study arms.	52 weeks
Secondary	Study Drug Compliance	Level of compliance with study drug through patient recall and patient medication diary.	52 weeks