Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
HI-PRO 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.Check my eligibility
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.See study design
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.
HI-PRO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had symptoms return while on blood thinner treatment.
Select...
I have been on blood thinner medication for at least 3 months.
Select...
I have a long-term lung condition like COPD, asthma, or interstitial lung disease.
Select...
I have a long-term inflammatory or autoimmune condition.
Select...
I have kidney disease but my creatinine is 2.5 mg/dL or lower.
Select...
I am unable to move around freely due to paralysis or other conditions.
Select...
I am 18 years old or older.
Select...
I have heart failure.
HI-PRO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of major bleeding
Frequency of symptomatic, recurrent VTE defined as the composite of deep vein thrombosis and/or pulmonary embolism
Secondary outcome measures
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 outcome measures
Adherence to the twice-daily regimen of apixaban (and placebo)
Frequency of clinically relevant non-major bleeding
HI-PRO Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Extended Duration ThromboprophylaxisExperimental Treatment1 Intervention
apixaban 2.5 mg orally twice daily for a duration of 12 months
Group II: ControlPlacebo Group1 Intervention
oral placebo for a duration of 12 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apixaban 2.5 MG
2022
Completed Phase 3
~1260
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,609 Previous Clinical Trials
11,469,727 Total Patients Enrolled
12 Trials studying Deep Vein Thrombosis
480,551 Patients Enrolled for Deep Vein Thrombosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live less than 12 months or are currently receiving hospice care.I am either a man or a woman.I haven't had symptoms return while on blood thinner treatment.I have been on blood thinner medication for at least 3 months.You have been diagnosed with a blood clot in a deep vein or in the lungs.I have a serious liver or bile duct condition.I have a long-term lung condition like COPD, asthma, or interstitial lung disease.I have a bleeding disorder or have recently bled a lot.I have a long-term inflammatory or autoimmune condition.I have kidney disease but my creatinine is 2.5 mg/dL or lower.I cannot take blood thinning medications.I haven't taken anticoagulants or low-dose aspirin in over 6 months.I have had active cancer in the last 5 years.You are very overweight, with a body mass index (BMI) of 30 or higher.I am on blood thinners or aspirin higher than 81 mg daily.I am unable to move around freely due to paralysis or other conditions.Your hemoglobin, platelet, or creatinine levels are too low, or your liver function tests are too high.I have a severe blood clotting disorder requiring long-term blood thinner treatment.I am 18 years old or older.And have at least one of the following ongoing factors that increase the risk of blood clots:I am not pregnant or breastfeeding.You are being held against your will for treatment of a mental or physical illness.I have heart or blood vessel disease due to plaque buildup.I have heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Extended Duration Thromboprophylaxis
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions is Extended Duration Thromboprophylaxis typically employed to treat?
"Extended Duration Thromboprophylaxis offers an effective treatment for conditions like atrial fibrillation, deep vein thrombosis, and various other diseases."
Answered by AI
Does this experiment currently need additional participants?
"Affirmative. According to information housed on clinicaltrials.gov, this study is currently recruiting volunteers; the original posting was made March 1st 2021 and it has since been refreshed on July 5th 2022. 600 participants are required for this single-site project."
Answered by AI
To what extent does Extended Duration Thromboprophylaxis threaten patient safety?
"Our team has deemed Extended Duration Thromboprophylaxis to be safe and reliable based on the Phase 4 trial data, thus awarding it a score of 3 out of 3."
Answered by AI
Is this a pioneering exploration of the topic?
"Currently, 47 live trials exploring Extended Duration Thromboprophylaxis are being conducted in 379 cities across 34 different countries. This research began in 2015 when Pfizer sponsored a Phase 4 drug trial with 4012 participants. Since then, 177 more studies have been completed."
Answered by AI
What is the current sample size for this scientific research?
"Yes, the information available on clinicaltrials.gov confirms that this ongoing medical trial is recruiting participants. First posted on March 1st 2021, it was last updated July 5th 2022 and looks to enroll 600 patients from one centre."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger