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Anticoagulant

Low-Intensity Apixaban for Blood Clots (HI-PRO Trial)

Phase 4

Waitlist Available

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has not suffered symptomatic recurrence during prior anticoagulant therapy

Treated for at least 3 months with standard therapeutic anticoagulant therapy

Must not have

Active severe hepatobiliary disease

History of bleeding diathesis or have had recent active bleeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing low-intensity apixaban versus placebo for extended prevention of recurrence after provoked VTE in patients with at least one persistent provoking factor. The primary safety outcome is ISTH major bleeding at 12 months, and the primary efficacy outcome is symptomatic, recurrent VTE at 12 months.

Who is the study for?

This trial is for adults with a history of provoked venous thromboembolism (VTE), such as deep vein thrombosis or pulmonary embolism, who have at least one ongoing risk factor like chronic kidney disease, immobility, inflammatory disorders, heart failure, or obesity. Participants must have completed initial anticoagulant therapy without recurrence and cannot be pregnant or breastfeeding.

What is being tested?

The study tests if low-intensity apixaban (2.5mg twice daily) can prevent VTE recurrence better than a placebo in high-risk patients after initial treatment. It's a randomized trial where half the participants get apixaban and half get a placebo pill to compare safety and effectiveness over 12 months.

What are the potential side effects?

Potential side effects include bleeding risks which are being closely monitored as the primary safety concern. Other common side effects may involve bruising easily, nosebleeds, gastrointestinal bleeding, and possibly anemia due to blood loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had symptoms return while on blood thinner treatment.

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I have been on blood thinner medication for at least 3 months.

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I have a long-term lung condition like COPD, asthma, or interstitial lung disease.

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I have a long-term inflammatory or autoimmune condition.

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I have kidney disease but my creatinine is 2.5 mg/dL or lower.

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I am unable to move around freely due to paralysis or other conditions.

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I am 18 years old or older.

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I have heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious liver or bile duct condition.

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I have a bleeding disorder or have recently bled a lot.

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I cannot take blood thinning medications.

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I have had active cancer in the last 5 years.

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I am on blood thinners or aspirin higher than 81 mg daily.

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I have a severe blood clotting disorder requiring long-term blood thinner treatment.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of major bleeding

Frequency of symptomatic, recurrent VTE defined as the composite of deep vein thrombosis and/or pulmonary embolism

Secondary study objectives

Frequency of the composite of death due to cardiovascular cause, nonfatal myocardial infarction (MI), stroke or systemic embolism, critical limb ischemia (CLI), or coronary or peripheral ischemia requiring revascularization

Other study objectives

Adherence to the twice-daily regimen of apixaban (and placebo)

Frequency of clinically relevant non-major bleeding