Trial Outcomes & Findings for AntiPhospholipid Syndrome Low-molecular-weight Heparin Pregnancy Loss Evaluation: The Pilot Study (NCT NCT03100123)

NCT ID: NCT03100123

Last Updated: 2020-04-08

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: EARLY_PHASE1
• Target enrollment: 1 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2020-04-08

Participant Flow

Participant milestones

Measure	Standard of Care Arm Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery. 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 Arm Open-label low-dose Aspirin 81 mg daily from randomization until delivery. Aspirin 81 mg: Aspirin 81 mg po daily in tablet form.
Overall Study STARTED	0	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Standard of Care Arm Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery. 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 Arm n=1 Participants Open-label low-dose Aspirin 81 mg daily from randomization until delivery. Aspirin 81 mg: Aspirin 81 mg po daily in tablet form.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: 1 participant was recruited (ASA alone arm) and the pilot trial was stopped early due to feasibility.

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

Outcome measures

Measure	Standard of Care Arm Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery. 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 Arm n=1 Participants Open-label low-dose Aspirin 81 mg daily from randomization until delivery. Aspirin 81 mg: Aspirin 81 mg po daily in tablet form.
Study Feasibility: Mean Recruitment Rate Per Center Per Month	—	1 participants

SECONDARY outcome

Timeframe: 18 months

Population: Site #1 was able to obtain all applicable approvals and begin recruitment in 12 months. Not applicable applicable for site #2 as study was closed early due to low recruitment.

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

Outcome measures

Measure	Standard of Care Arm n=1 Participants Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery. 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 Arm Open-label low-dose Aspirin 81 mg daily from randomization until delivery. Aspirin 81 mg: Aspirin 81 mg po daily in tablet form.
Essential Documents	1 Sites	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Standard of Care Arm n=25 Participants Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery. 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 Arm Open-label low-dose Aspirin 81 mg daily from randomization until delivery. Aspirin 81 mg: Aspirin 81 mg po daily in tablet form.
Eligibility	4 Participants	—

SECONDARY outcome

Timeframe: 24 months

Proportion of eligible subjects who provide consent.

Outcome measures

Measure	Standard of Care Arm n=4 Participants Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery. 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 Arm Open-label low-dose Aspirin 81 mg daily from randomization until delivery. Aspirin 81 mg: Aspirin 81 mg po daily in tablet form.
Consent	1 Participants	—

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Measure	Standard of Care Arm n=1 Participants Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery. 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 Arm Open-label low-dose Aspirin 81 mg daily from randomization until delivery. Aspirin 81 mg: Aspirin 81 mg po daily in tablet form.
Withdrawals/Loss to Follow-up	0 Participants	—

SECONDARY outcome

Timeframe: 52 weeks

Crossover rate between standard of care and experimental study arms.

Outcome measures

Measure	Standard of Care Arm n=1 Participants Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery. 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 Arm Open-label low-dose Aspirin 81 mg daily from randomization until delivery. Aspirin 81 mg: Aspirin 81 mg po daily in tablet form.
Crossover Rate	0 Participants	—

SECONDARY outcome

Timeframe: 52 weeks

Population: No participants in standard of care arm

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

Outcome measures

Measure	Standard of Care Arm Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery. 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 Arm n=1 Participants Open-label low-dose Aspirin 81 mg daily from randomization until delivery. Aspirin 81 mg: Aspirin 81 mg po daily in tablet form.
Study Drug Compliance	0 Participants	1 Participants

Adverse Events

Standard of Care Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Leslie Skeith

Ottawa Hospital Research Institute

Phone: 403-944-5246

Email: laskeith@ucalgary.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place