Low-Intensity Apixaban for Blood Clots

(HI-PRO Trial)

Overseen By Gregory Piazza, MD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Brigham and Women's Hospital

Must not be taking: Anticoagulants, Dual antiplatelets

Disqualifiers: Pregnancy, Active cancer, Severe hepatobiliary, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether a low dose of apixaban, a blood thinner, can safely prevent the recurrence of blood clots (VTE) after initial treatment. It focuses on individuals whose blood clots stem from ongoing risk factors, such as obesity or chronic lung disease. Those treated for at least three months for a blood clot and who have a lasting condition that could trigger another clot may find this trial suitable. Participants will be randomly assigned to take either apixaban or a placebo for a year, with follow-ups to monitor for new clots or bleeding issues. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not need ongoing anticoagulant therapy, dual antiplatelet therapy, or certain other medications. If you are on these, you may need to stop them to participate. It's best to discuss your specific medications with the trial team.

What is the safety track record for low-intensity apixaban?

A previous study showed that apixaban reduced the risk of repeat blood clots by 87% in patients with certain risk factors. Most people find this medication easy to take. Bleeding is the most common side effect, occurring in 1% to 10% of patients, while more serious bleeding occurs in about 3% or fewer of those taking apixaban.

Another study found that people taking a low dose of apixaban had a lower death rate compared to those taking a placebo, a pill with no active medicine. These findings suggest that low-dose apixaban is a safe option for long-term prevention of blood clots, with manageable side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard blood clot treatments that often involve higher doses of anticoagulants like warfarin or full-strength apixaban, this study uses a low-intensity dose of apixaban, specifically 2.5 mg taken orally twice daily. Researchers are excited because this lower dose may still effectively prevent blood clots while potentially reducing the risk of bleeding, a common side effect with higher doses of anticoagulants. This approach could offer a safer alternative for long-term prevention in patients, making it a promising option in the management of blood clots.

What evidence suggests that low-intensity apixaban might be an effective treatment for VTE?

Research has shown that taking a low dose of apixaban, 2.5 mg twice daily, helps prevent the recurrence of blood clots in individuals with a previous clot due to a known cause. In this trial, some participants will receive this low dose of apixaban as part of the extended duration thromboprophylaxis arm. Studies have found that this dose can reduce the risk of another clot, such as deep vein thrombosis in the leg or pulmonary embolism in the lung. Importantly, the risk of serious bleeding with this treatment remains low. Apixaban is already a trusted medication for treating and preventing blood clots, making it a reliable choice for ongoing treatment. Overall, this low dose effectively prevents the return of blood clots with minimal side effects. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am either a man or a woman.

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

Outpatient follow-up at BWH

Exclusion Criteria

You are expected to live less than 12 months or are currently receiving hospice care.

Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control

Any other medical, social, logistical, or psychological reason, which in the opinion of the investigator, would preclude compliance with, or successful completion of, the study protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Anticoagulation Treatment

Participants complete at least 3 months of standard therapeutic anticoagulation

12 weeks

Extended Treatment

Participants receive low-intensity apixaban (2.5 mg twice daily) or placebo for extended-duration secondary prevention of VTE

12 months

Regular visits for monitoring and adherence checks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

EHR review at 12 months from study enrollment

What Are the Treatments Tested in This Trial?

Interventions

• Apixaban 2.5 MG
• Placebo oral tablet

Trial Overview 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.

How Is the Trial Designed?

Group I: Extended Duration Thromboprophylaxis Experimental Treatment 1 Intervention

apixaban 2.5 mg orally twice daily for a duration of 12 months

Group II: Control Placebo Group 1 Intervention

oral placebo for a duration of 12 months

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2509426

Apixaban for Extended Treatment of Provoked Venous ... Oral apixaban (at a dose of 2.5 mg twice daily) was effective for the prevention of symptomatic recurrent VTE in patients with provoked VTE ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40888734/

Apixaban for Extended Treatment of Provoked Venous ... The primary efficacy outcome was the first symptomatic recurrent VTE. The primary safety outcome was the first episode of major bleeding ...

3. eliquis.com eliquis.com/eliquis/hcp/realworldevidence

Real-World Evidence | Rx ELIQUIS® (apixaban) for HCPs Eliquis indicated for the treatment of adults with deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE ...

4. escardio.org escardio.org/The-ESC/Press-Office/Press-releases/Extended-blood-thinning-treatment-lowers-recurrence-in-at-risk-patients-with-provoked-venous-thromboembolism

Extended blood-thinning treatment lowers recurrence in at- ... Apixaban 2.5 mg twice daily reduced the risk of symptomatic recurrent VTE vs. placebo at 12 months. There was a low risk of major bleeding with ...

5. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/eliquis

Eliquis | European Medicines Agency (EMA) In the study comparing Eliquis with warfarin, 1.3 % of the patients taking Eliquis had a stroke or clotting event every year compared with 1.6% of the patients ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK507910/

Apixaban - StatPearls - NCBI Bookshelf As an anticoagulant, apixaban's most common adverse effect is bleeding (1% to 10%). The risk of major bleeding is 3% or less, and clinically ...

7. eliquis.com eliquis.com/eliquis/hcp/efficacy-safety

Efficacy and Safety Data | Rx ELIQUIS® (apixaban) for HCPs An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical trials in atrial fibrillation patients. If ELIQUIS is ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa1207541

Apixaban for Extended Treatment of Venous ... The rate of death from any cause was 1.7% in the placebo group, as compared with 0.8% in the 2.5-mg apixaban group and 0.5% in the 5-mg apixaban group.

9. eliquis.bmscustomerconnect.com eliquis.bmscustomerconnect.com/vte/consider-eliquis

Why Rx ELIQUIS® (apixaban) for DVT & PE | Safety Info Almost 98% of patients on ELIQUIS didn't experience another DVT/PE blood clot after initial treatment for DVT/PE. In this study, 2.7% of LOVENOX®/warfarin ...