Pradaxa

Deep Vein Thrombosis (DVT), Deep Vein Thrombosis, Pulmonary Embolism + 12 more

Treatment

12 FDA approvals

20 Active Studies for Pradaxa

What is Pradaxa

Dabigatran etexilate

The Generic name of this drug

Treatment Summary

Dabigatran etexilate is a medication that helps prevent blood clots by inhibiting thrombin, an enzyme involved in clotting. It is taken orally and is converted to a drug called dabigatran when it is metabolized in the body. It was approved by the FDA in 2010 and is commonly prescribed to prevent venous thromboembolic events. Unlike warfarin, it does not require monitoring with lab tests, making it a convenient treatment option.

Pradaxa

is the brand name

image of different drug pills on a surface

Pradaxa Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Pradaxa

Dabigatran etexilate

2010

23

Approved as Treatment by the FDA

Dabigatran etexilate, also known as Pradaxa, is approved by the FDA for 12 uses including Recurrent Pulmonary Embolism (Disorder) and Prophylaxis of Deep Vein Thrombosis .

Recurrent Pulmonary Embolism (Disorder)

Prophylaxis of Deep Vein Thrombosis

Deep Vein Thrombosis

Deep vein thrombosis recurrent

Pulmonary Embolism

Pulmonary Embolism

Total Knee Arthroplasty

Deep Vein Thrombosis

Pulmonary Embolism

Disease

Deep Vein Thrombosis

recurrent Prophylaxis of Deep Vein Thrombosis

Effectiveness

How Pradaxa Affects Patients

Dabigatran is a type of medicine that prevents blood clots. Its effects can be seen through longer clotting times in tests like the activated partial thromboplastin time (aPTT), ecarin clotting time (ECT), thrombin time (TT), and dilute thrombin time (dTT). There is an increased risk of bleeding when taking dabigatran, especially if taken with other medicines like antiplatelet agents, fibrinolytic therapy, heparins, or NSAIDs. It should not be used with neuraxial anesthesia or spinal puncture as it

How Pradaxa works in the body

Dabigatran works to balance coagulation in the body. Normally, thrombin, a serine protease, activates prothrombin which then forms fibrin fibres and platelets to form clots. Too much clotting can be bad for your health and so dabigatran is used to reduce thrombin activity. Dabigatran is a reversible direct thrombin inhibitor which means it can be turned on and off, allowing some normal clotting activity to occur. It also inhibits platelet aggregation, though the exact mechanism is unknown.

When to interrupt dosage

The proposed dosage of Pradaxa is contingent upon the diagnosed condition, such as Systemic Embolism, Deep Vein Thrombosis and recurrent Prophylaxis of Deep Vein Thrombosis. The measure of dosage can be found in the subsequent table, depending on the technique of delivery (e.g. Capsule - Oral or Capsule).

Condition

Dosage

Administration

Systemic Embolism

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

Disease

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

Stroke

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

Pulmonary Embolism

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

Total Knee Arthroplasty

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

following at least 5 days of initial therapy with a parenteral anticoagulant

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

Atrial Fibrillation

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

previously treated

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

Deep Vein Thrombosis

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

Pulmonary Embolism

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

Pulmonary Embolism

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

Hip structure

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

Deep Vein Thrombosis (DVT)

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

Deep Vein Thrombosis

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

recurrent Prophylaxis of Deep Vein Thrombosis

, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral

Warnings

Pradaxa has three contraindications which preclude its combination with the conditions given in the below table.

Pradaxa Contraindications

Condition

Risk Level

Notes

mechanical prosthetic heart valve

Do Not Combine

Hemorrhage

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Dabigatran Etexilate may interact with Pulse Frequency

There are 20 known major drug interactions with Pradaxa.

Common Pradaxa Drug Interactions

Drug Name

Risk Level

Description

(R)-warfarin

Major

Dabigatran etexilate may increase the anticoagulant activities of (R)-warfarin.

(S)-Warfarin

Major

Dabigatran etexilate may increase the anticoagulant activities of (S)-Warfarin.

4-hydroxycoumarin

Major

Dabigatran etexilate may increase the anticoagulant activities of 4-hydroxycoumarin.

Abciximab

Major

Dabigatran etexilate may increase the anticoagulant activities of Abciximab.

Acenocoumarol

Major

Dabigatran etexilate may increase the anticoagulant activities of Acenocoumarol.

Pradaxa Toxicity & Overdose Risk

There is not enough data available to know the effects of dabigatran on pregnant women, labor and delivery, nursing mothers, or children. Elderly people may be more likely to experience side effects, but the drug can still be beneficial. People with reduced kidney function should take a lower dose of the drug. Animal studies have shown that dabigatran can lead to dead offspring and bleeding near the time of birth. It is unknown whether the drug is passed through breast milk, so the potential risks must be weighed against the benefits before taking it or breastfeeding.

image of a doctor in a lab doing drug, clinical research

Pradaxa Novel Uses: Which Conditions Have a Clinical Trial Featuring Pradaxa?

99 active clinical trials are currently investigating the potential of Pradaxa to provide relief from Pulmonary Embolism, Anticoagulant Therapy and Systemic Embolism.

Condition

Clinical Trials

Trial Phases

Pulmonary Embolism

22 Actively Recruiting

Early Phase 1, Phase 4, Phase 3, Not Applicable

Systemic Embolism

2 Actively Recruiting

Not Applicable

recurrent Prophylaxis of Deep Vein Thrombosis

0 Actively Recruiting

Disease

0 Actively Recruiting

Total Knee Arthroplasty

6 Actively Recruiting

Not Applicable, Phase 2, Phase 3

Atrial Fibrillation

2 Actively Recruiting

Not Applicable

Deep Vein Thrombosis (DVT)

31 Actively Recruiting

Phase 4, Not Applicable, Early Phase 1, Phase 3, Phase 2, Phase 1

Stroke

6 Actively Recruiting

Not Applicable, Phase 1

Pulmonary Embolism

0 Actively Recruiting

Deep Vein Thrombosis

0 Actively Recruiting

Pulmonary Embolism

0 Actively Recruiting

following at least 5 days of initial therapy with a parenteral anticoagulant

0 Actively Recruiting

Deep Vein Thrombosis

9 Actively Recruiting

Not Applicable, Phase 2, Phase 3, Phase 4

previously treated

0 Actively Recruiting

Hip structure

0 Actively Recruiting

Pradaxa Reviews: What are patients saying about Pradaxa?

5

Patient Review

2/9/2016

Pradaxa for Treatment to Prevent Blood Clots in Chronic Atrial Fibrillation

I was disappointed when I received my last refill in the form of a blister package instead of a bottle. It's not safe to have to use scissors to remove the pill, and there's no way to see the pill itself through the packaging. This could easily lead to damaging the pill.

4.7

Patient Review

12/19/2014

Pradaxa for Treatment to Prevent a Blood Clot in the Lung

I've been taking this treatment for three years now and it seems to be working well. I don't have excessive bleeding or bruising, which is great.

4.3

Patient Review

10/16/2017

Pradaxa for Treatment to Prevent Blood Clots in Chronic Atrial Fibrillation

I became anemic after seven years on this medication. I would recommend getting your blood checked frequently while taking this drug.

3.7

Patient Review

10/16/2014

Pradaxa for Deep Vein Thrombosis Prevention

I had a DVT and PE about 10 years ago. I was initially put on Coumadin/Warfarin for treatment, but then I got another PE. So, my hematologist switched me to Lovenox injections, which are quite expensive. Then Pradaxa came out and I thought it was amazing. But after being on it for a while, I developed severe hemorrhoids. My hematologist denied that the medication was the cause, but after switching to Xarelto, my hemorrhoids cleared up within a week.

3.7

Patient Review

9/22/2014

Pradaxa for Deep Vein Thrombosis Prevention

I had another pulmonary embolism while on coumadin, and the only available option at the time was heparin injections. These were quite expensive, so I took them for two years until Pradaxa became available. However, after being on Pradaxa for a month or so, I developed hemorrhoids which grew progressively worse. My hemotologist insisted that this drug wasn't the cause of my hemorrhoids but agreed to switch me to Xarelto instead. I've been happily taking Xarelto for over a year now with no side effects whatsoever.

3.3

Patient Review

12/6/2014

Pradaxa for Blood Clot in Lung

I unfortunately developed a really unpleasant body odor while on this drug. Additionally, I had some pain in my right kidney area. However, since discontinuing the drug per my doctor's orders, both the smell and pain have gone away.

3

Patient Review

3/19/2017

Pradaxa for Treatment to Prevent Blood Clots in Chronic Atrial Fibrillation

I was given this prescription by my doctor, but I'm not sure how to use it yet. The pill is difficult to get out of the packaging; my wife and I spent half an hour trying before giving up and just cutting the pill out. Not safe.

3

Patient Review

2/3/2019

Pradaxa for Blood Clot in a Deep Vein

This drug helped with my DVT, but unfortunately it also caused some really terrible heartburn. I would get it about every ten days or so, and it was just awful. I always felt nauseous, and even though I never got diarrhea, I had to poop a lot more than usual (like, six times a day). And then the final straw was when I started bleeding rectally. That's when I decided to switch insurance companies and ditch this medication.

3

Patient Review

5/30/2019

Pradaxa for Blood Clot in a Deep Vein

I recently started taking Pradaxa to help with my Afib. The packaging is terrible and very difficult to open without scissors, but I haven't had any negative side effects yet.

2.7

Patient Review

6/5/2021

Pradaxa for Treatment to Prevent Blood Clots in Chronic Atrial Fibrillation

The pill is effective, but hard to swallow. It doesn't slide down your throat easily like it should. I've started coating the pill in butter, which helps a bit. But really, the manufacturer should do something about this issue.

1.3

Patient Review

5/23/2021

Pradaxa for Treatment to Prevent Blood Clots in Chronic Atrial Fibrillation

I took this drug for a couple months before switching back to Eliquis. The reason being that I experienced chronic side effects like mouth sores, bruising, diarrhea, and bleeding.

1

Patient Review

9/20/2015

Pradaxa for Deep Vein Thrombosis Prevention

I've been feeling really lousy since I started taking this medication. My stomach is upset, my body aches, and I just don't feel well at all. Plus, I'm not even walking as much as usual according to my Fitbit. When I went to the doctor yesterday, they said I need to keep taking it for six more months and prescribed another pill (gabapentin) for the pain. That's just too many pills for me.

1

Patient Review

12/11/2019

Pradaxa for Prevention for a Blood Clot going to the Brain

This medication is quite strong and has a lot of potential side effects that I unfortunately experienced first-hand. These include body aches, stomach pain, terrible hemorrhoids, insomnia, jitters, and swelling in my legs.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about pradaxa

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What's the difference between Eliquis and Pradaxa?

"Eliquis and Pradaxa work by blocking the action of clotting factors in your blood. Eliquis blocks factor Xa, and Pradaxa blocks thrombin. This prevents blood clots from forming in your blood vessels."

Answered by AI

What foods should you avoid while taking Pradaxa?

"There are no dietary restrictions. However, you may need to limit many foods with vitamin K, such as leafy green vegetables and some vegetable oils. This is because vitamin K can affect the way warfarin works in your body."

Answered by AI

What is the drug Pradaxa used for?

"Pradaxa is a medication used to thin the blood and prevent the formation of blood clots. It is commonly used after surgery or in patients with an abnormal heart beat."

Answered by AI

What is the most common side effect of Pradaxa?

"Pradaxa is most commonly associated with bleeding, as it inhibits the body's ability to clot. This can manifest as increased bruising or longer bleeding after cuts or injuries."

Answered by AI

Clinical Trials for Pradaxa

Image of Brigham and Women's Hospital in Boston, United States.

Rosuvastatin for Cancer-Associated Blood Clots

18+
All Sexes
Boston, MA

Patients with cancer are at high risk for life-threatening venous thromboembolism (VTE) yet rarely receive anticoagulant prophylaxis due to bleeding risks. Thus, effective prophylaxis in oncology requires a method to reduce VTE without increasing hemorrhage. The primary aim of the Statin Therapy to Prevent Cancer Associated Venous Thromboembolism (STAT-CAT) trial is to test whether rosuvastatin 20 mg daily for 12 months compared to placebo can safely prevent VTE in patients with newly diagnosed or recently relapsed cancer who are at increased thrombotic risk, are not planned to be anticoagulated, and who do not otherwise take statin therapy.

Phase 4
Waitlist Available

Brigham and Women's Hospital (+1 Sites)

Image of Vermont Health in Burlington, United States.

Clinical Program for VTE Prevention in Cancer

18+
All Sexes
Burlington, VT

assess effectiveness of a , compared with usual care, to assess The goal of this study is to learn if a modified clinical program can improve adherence to guideline recommendations for prevention of venous thromboembolism in ambulatory patients with cancer. The main question\[s\] it aims to answer are: Does the modified program improve number of ambulatory oncology patients starting systemic treatment getting VTE risk-assessment? Does the modified program improve the number of patients receiving appropriate preventative anticoagulation? Researchers will compare to usual care (no clinical program). Participant clinicians will be asked to * receive education about VTE prevention recommendations * carry out risk assessment, anticoagulation discussions, and document the results Participant patients will receive care from clinicians participating in the study as part of their cancer care.

Waitlist Available
Has No Placebo

Vermont Health

Karlyn Martin, MD

Image of Inova Alexandria Hospital in Alexandria, United States.

Heparin Dosing for Blood Clots and Heart Conditions

18+
All Sexes
Alexandria, VA

The goal of this clinical trial study is to test whether a mathematical calculation, using the patient's gender, weight and kidney function, can better predict a patient's heparin goal dose than a flat number of units per patient weight can. Participants will have the first dose of heparin infusion calculated, after which if adjustments are needed, the Hospital's prebuilt table for results driven dosing for this purpose is used. The researchers will compare the time it takes for the participants to get to the desired goal using the patient's information for calculation versus patients in the past who received the medication using the flat rate. The hypothesis is that the patients with enhanced personal data, gender, weight and kidney function, included for the initial dose, will get to their goal lab value sooner and with less chance of delay or overshooting the goal. A quicker time to goal lab value is beneficial to patients in many ways, including earlier treatment of the clot or coronary issue that the patient is experiencing.

Phase 4
Waitlist Available

Inova Alexandria Hospital

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Image of SUNY Upstate in Syracuse, United States.

Apixaban or Enoxaparin for Head and Neck Cancer Surgery

18 - 89
All Sexes
Syracuse, NY

The goal of this clinical trial is to learn if apixaban (a pill) is a safe and easier alternative to taking enoxaparin (a daily shot) to prevent blood clots after head and neck cancer surgery. It will also learn about side effects of both medicines. The main questions it aims to answer are: Can apixaban be used safely instead of enoxaparin to prevent blood clots after surgery? Do patients find apixaban easier or more satisfying to take than enoxaparin? How well do patients follow the treatment plan with each medicine? Researchers will compare 2 groups: One group will take apixaban (a pill taken twice a day) for 10 days after surgery. The other group will take enoxaparin (a shot given once a day) for 10 days after surgery. Participants will: Take either apixaban or enoxaparin starting 12-24 hours after surgery, for 10 days total Keep a medication diary and bring back unused medicine so the study team can check adherence Complete short surveys about satisfaction with their medicine Have an ultrasound of their legs to check for blood clots 11-14 days after surgery Return for follow-up visits about 40 days and 80 days after surgery for safety checks How long will participation last? About 4 months from surgery through the last follow-up visit.

Phase 4
Recruiting

SUNY Upstate

Image of Brooks Rehabilitation Clinical Research Center in Jacksonville, United States.

Q Therapeutic System for Stroke

18 - 80
All Sexes
Jacksonville, FL

This trial tests a promising new intervention to promote post-stroke neural reorganization and functional recovery. The Q Therapeutic (BQ 3.0) is a wearable medical system that produces and delivers non-invasive, extremely-low-intensity and low-frequency, frequency-tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery. This trial is a prospective, single-arm, open-label, single center clinical trial designed to evaluate the safety, feasibility, and efficacy of the Q Therapeutic (BQ 3.0) System in the rehabilitation of people with chronic stroke.

Recruiting
Has No Placebo

Brooks Rehabilitation Clinical Research Center

Emily Fox, PT, DPT, MHS, PhD

BrainQ Technologies Ltd.

Image of Denver Metro Orthopedics, P.C. Englewood Location in Englewood, United States.

REGN7508 for Venous Thromboembolism

18+
All Sexes
Englewood, CO

This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery. The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related diseases after total knee replacement surgery. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Phase 3
Recruiting

Denver Metro Orthopedics, P.C. Englewood Location (+10 Sites)

Clinical Trial Management

Regeneron Pharmaceuticals

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Have you considered Pradaxa clinical trials?

We made a collection of clinical trials featuring Pradaxa, we think they might fit your search criteria.
Go to Trials