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Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS

ConditionsAntiphospholipid SyndromeArterial Thrombosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMcMaster University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients of at least 18 years of age with confirmed antiphospholipid syndrome according to Sydney criteria and with first or recurrent arterial thrombotic manifestation, including those with asymptomatic brain infarcts on diagnostic imaging.

Treatment with either A) a vitamin K antagonist (VKA) with therapeutic range, international normalized ratio (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 or C) VKA with therapeutic range, INR 3.0-4.0, or D) with a dual antiplatelet regimen, if considered appropriate by the treating physician.

Signed informed consent obtained (in jurisdictions where required).

Disqualifiers

Inability to follow the patient due to geographical or other reasons.

Patients with documented poor compliance.

Bleeding risk that in the opinion of the treating physician makes combination antithrombotic therapy unsafe.

Pregnancy or planned pregnancy.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Dual antiplatelet therapy

    Drug

    Aspirin plus any of clopidogrel, ticagrelor or prasugrel

  • Combined antithrombotic therapy

    Drug

    Combination of a vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with low-dose aspirin.

  • Vitamin K antagonist standard intensity

    Drug

    vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 2.0-3.0

  • Vitamin K antagonist high intensity

    Drug

    vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 3.0-4.0

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years
2

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

Time frame
2 years

Secondary outcomes

1

Number of Participants with arterial thrombosis verified by diagnostic imaging

stroke, myocardial infarction, peripheral arterial thrombosis or embolism

Time frame
2 years
2

Number of Participants with venous thromboembolism verified by diagnostic imaging

thrombosis in any deep vein or pulmonary embolism

Time frame
2 years
3

Number of Participants with vascular death verified by diagnostic imaging, electrocardiogram or troponin rise

Death due to arterial or venous thromboembolism

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

International Society on Thrombosis and Haemostasis

Collaborator

Source ClinicalTrials.gov
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