AntiPhospholipid Syndrome Low-molecular-weight Heparin Pregnancy Loss Evaluation: The Pilot Study (APPLE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03100123|
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : November 21, 2017
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|
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|
|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)|
|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|
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.
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
- Feasibility [ Time Frame: 24 months ]The primary feasibility outcome of the pilot trial is the mean recruitment rate per center per month.
- 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.
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
|Contact: Leslie Skeith, MD||613-737-8899 ext firstname.lastname@example.org|
|Contact: Veronica Whitham, BSc||613-737-8899 ext email@example.com|
|McMaster University Medical Centre||Not yet recruiting|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Contact: Shannon Bates, M.D. 905 521-2100 ext 73928 firstname.lastname@example.org|
|Contact: Shannon Dodds email@example.com|
|Principal Investigator: Shannon Bates, MD|
|Ottawa Hospital Research Institute||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: Marc Rodger, MD 613-737-8899 ext 74641 firstname.lastname@example.org|
|Contact: Veronica Whitham, BSc 613-737-8899 ext 71068 email@example.com|
|Principal Investigator: Marc Rodger, MD|
|Principal Investigator:||Marc Rodger, MD||Ottawa Hospital Research Institute|
|Principal Investigator:||Leslie Skeith, MD||Ottawa Hospital Research Institute|