NCT05646394|Recruiting
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Sponsor study identifier
observational
150
2 countries
3
Study Start
July 1, 2022
Actual (reported)Primary Completion
July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this registry is to gather more information on the efficacy and safety of various antithrombotic regimens. The registry collects data on patients with antiphospholipid syndrome and an arterial event within the past 12 months, on treatment with either A) a VKA with therapeutic range, INR 2.0-3.0 plus low-dose aspirin (75-100 mg daily), B) a VKA alone with therapeutic range, INR 2.0-3.0, C) a VKA with therapeutic range, INR 3.0-4.0, or D) with a dual antiplatelet regimen. The follow-up is 2 years.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2022
Actual (reported)December 5, 2022
Actual (reported)December 12, 2022
Actual (reported)July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of Participants with thromboembolism verified by diagnostic imaging, electrocardiogram or troponin rise
Composite of arterial thrombosis (stroke, myocardial infarction, peripheral arterial thrombosis or embolism), venous thromboembolism (thrombosis in any deep vein or pulmonary embolism), and vascular death.
2 years
Number of Participants with major hemorrhage fulfilling at least one of the International Society on Thrombosis and Haemostasis criteria
Major hemorrhage according to the International Society on Thrombosis and Haemostasis
2 years
Number of Participants with arterial thrombosis verified by diagnostic imaging
2 years
Number of Participants with venous thromboembolism verified by diagnostic imaging
2 years
Number of Participants with vascular death verified by diagnostic imaging, electrocardiogram or troponin rise
2 years
Aspirin plus any of clopidogrel, ticagrelor or prasugrel
Combination of a vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with low-dose aspirin.
The decision on the treatment regimen should have been made by the treating physician on clinical grounds and judgement, prior to informing the patients about the registry. The information should include that vitamin K antagonist is the recommended standard, either alone or in combination and, in case dual antiplatelet regimen is chosen, an explanation to the patient for what reasons it should be used or continued. Patients that have been started on either of the eligible regimens after the most recent arterial thromboembolic event and within the past 12 months can be approached and informed about the study. If the patient meets the inclusion criteria and does not have any of the exclusion criteria, the investigator or designated representative obtains consent for collection of data.
Instituto de Investigaciones en Salud Pública, Universidad de Buenos Aires
Buenos Aires, Buenos Aires F.D., C1113 AAJ, Argentina
Clinica Universitaria Reina Fabiola
Córdoba, Argentina
Cary Clark
International Society on Thrombosis and Haemostasis
First Submitted
December 5, 2022
First Posted
December 12, 2022
Study Start
July 1, 2022
Actual (reported)Primary Completion
July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The BeLimumab Antiphospholipid Syndrome Trial (BLAST)
Clinical Outcomes of Primary Versus Secondary Antiphospholipid Syndrome
vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 2.0-3.0
vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 3.0-4.0
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
McMaster University
Hamilton, Ontario, L9H 7M1, Canada
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 9, 2025
Record last verified: 2025-11
The study protocol and ICF are available on the ISTH website (under SSC - RedCap. IPD will be shared after the primary publication.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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