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

600 Participants Needed

Trial Summary

What is the purpose of this trial?

Design: U.S.-based, single-center, randomized placebo-controlled trial. Brief Treatment Description: Low-intensity apixaban (2.5mg twice daily) for extended-duration secondary prevention of VTE after initial treatment for provoked VTE. Purpose: To establish the safety and efficacy of low-intensity apixaban versus placebo for extended prevention of recurrence after provoked VTE in patients with at least one persistent provoking factor. Population: Outpatients with provoked VTE with at least one persistent provoking factor. Enrollment: 600 subjects Randomization: 1:1 Clinical Site Locations: 1 center (Brigham and Women's Hospital) Study Duration: 36 months; enrollment period of up to 20 months with 12-month follow-up. Primary Safety and Efficacy Outcomes: Primary Safety Outcome: International Society on Thrombosis and Haemostasis (ISTH) major bleeding at 12 months. Primary Efficacy Outcome: Symptomatic, recurrent VTE, defined as the composite of deep vein thrombosis and/or pulmonary embolism at 12 months. Secondary Efficacy Outcome: The composite of death due to cardiovascular cause, nonfatal myocardial infarction, stroke or systemic embolism, critical limb ischemia, or coronary or peripheral ischemia requiring revascularization (major adverse cardiovascular events, including major adverse limb events) at 12 months. Follow-Up: Follow-up will consist of Electronic Health Record (EHR) review at 12-months from study enrollment. Interim Analysis: An interim analysis for the primary safety and efficacy outcomes will be performed when 300 subjects have completed 12-month follow-up.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+