Study on Lowering INR to Reduce Bleeding in Patients with Mechanical Aortic Valves Using Warfarin, Acenocoumarol, and Phenprocoumon

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What is this study about?

This clinical trial is focused on patients who have undergone a mechanical bileaflet aortic valve replacement and are being treated with a Vitamin K Antagonist. The study aims to evaluate the safety and effectiveness of maintaining a lower INR (International Normalized Ratio) range in these patients. The INR is a measure used to determine the clotting tendency of blood, which is important for patients with mechanical heart valves to prevent complications such as blood clots or bleeding.

The trial involves the use of medications such as Warfarin, Acenocoumarol, and Phenprocoumon, which are all types of Vitamin K Antagonists. These medications help to thin the blood and prevent clot formation. Participants in the study will be randomly assigned to receive one of these medications or a placebo. The study will monitor the participants over a period of up to 36 months to observe any occurrences of blood clots, strokes, or bleeding events.

The purpose of the study is to determine if a lower INR range can safely reduce the risk of bleeding while still effectively preventing blood clots in patients with mechanical heart valves. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the medication. The study will also track other health outcomes such as overall survival, any type of stroke, heart attacks, and other related conditions. This research is important to improve the management of patients with mechanical heart valves and to enhance their quality of life.

1 enrollment

Participation begins after providing written informed consent. This consent can be given by the patient or a substitute decision-maker.

Eligibility requires having a bileaflet mechanical heart valve implant in the aortic position for at least 3 months and being at least 18 years old.

2 medication administration

The trial involves the use of Vitamin K Antagonists such as acenocoumarol, warfarin, and phenprocoumon. These medications are taken orally.

The specific dosage and frequency will be determined by the study protocol and monitored by the research team.

3 monitoring and assessments

Regular monitoring of INR (International Normalized Ratio) levels is conducted to ensure they remain within a common, lower range. This is to evaluate the safety and efficacy of this range in patients with bileaflet aortic mechanical valves.

Assessments will include checking for any signs of thrombosis, thromboembolism, and bleeding, which are primary endpoints of the study.

4 follow-up and evaluation

Secondary endpoints such as all-cause mortality, all clinically important bleeding, and various types of strokes and thromboembolic events will be evaluated.

The study will also track the time patients spend in the therapeutic range and the proportion of patients with extreme INR values.

5 completion

The trial is estimated to conclude by December 31, 2026.

Upon completion, data will be analyzed to determine the overall safety and effectiveness of maintaining a lower INR range in the specified patient group.

Who Can Join the Study?

  • Have had a bileaflet mechanical heart valve implant in the aortic position at least 3 months ago. This means you had a specific type of artificial heart valve placed in your heart’s main artery at least 3 months ago.
  • Be at least 18 years of age at the time of enrollment. You must be 18 years old or older to join the study.
  • Provide written informed consent. This means you or someone who can make decisions for you must sign a document agreeing to participate in the study after understanding what it involves.

Who Cannot Join the Study?

  • Patients who are not being treated with a Vitamin K Antagonist. This is a type of medication that helps prevent blood clots.
  • Patients who do not have a mechanical bileaflet aortic valve replacement. This is a type of artificial heart valve used to replace a damaged one.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
University Hospital Jena KöR Jena Germany
Sydvestjysk Sygehus Esbjerg Denmark
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Algemeen Ziekenhuis Damiaan Oostende Ostend Belgium
Universitaetsklinikum Regensburg AöR Regensburg Germany
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Politecnica Delle Marche Ancona Italy
Justus-Liebig-Universitaet Giessen Giessen Germany
Ziekenhuis Oost Limburg Genk Belgium
Sygehus Soenderjylland Soenderborg Aabenraa Denmark
Citta di Lecce Hospital GVM Care & Research Lecce Italy
Iszsxc Bonheiden Belgium
Epcgldi Ubxoeshoiafb Mamqzxu Cxdieff Rgmmzprzc (wnjbkwa Mze Rotterdam The Netherlands
Apqevx Uutwkiufiw Htsqxsro Aarhus Denmark
Aqdikwc Orqwazbjcgg Nrzocahhx So Afdhqsf E Blbmdi E C Azpxek Amtmezmwruh Alexandria Italy
Apcubrb Oeuvslttlcd Uqwnmpdhnkjxi Otkocgbd Rlkfwal Foggia Italy
Hohonlfj Dt Lh Sgikj Cvbd I Span Phu Barcelona Spain
Hosphjpb Ugqqxksixpvrv Dk Ld Pbkjzcam Madrid Spain
Fobtcvnyi Pnyx Lt Islpofybyynet Bribzcijk Duo Hwrwrlxo Ugfgeafwbdvqn Lu Pgk Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.10.2021
Denmark Denmark
Recruiting
01.10.2021
Germany Germany
Recruiting
01.10.2021
Italy Italy
Recruiting
01.10.2021
Spain Spain
Recruiting
01.10.2021
The Netherlands The Netherlands
Recruiting
01.10.2021

Trial locations

Warfarin is a medication used to prevent blood clots. In this trial, it is being studied to see if using a lower range of its effect, measured by a blood test called INR, can safely reduce bleeding risks in patients with mechanical heart valves.

Thrombosis – Thrombosis is a condition where blood clots form in blood vessels, potentially obstructing blood flow. It can occur in veins or arteries and may lead to complications such as stroke or heart attack. The clot can remain in place or travel to other parts of the body, causing further blockages. Symptoms depend on the location of the clot and may include pain, swelling, or redness. If untreated, it can lead to tissue damage due to restricted blood flow.

Thromboembolism – Thromboembolism occurs when a blood clot breaks loose and travels through the bloodstream, potentially causing blockages in other vessels. This can lead to serious conditions like pulmonary embolism or stroke. The condition often arises from deep vein thrombosis, where clots form in the deep veins of the legs. Symptoms vary based on the location of the blockage and may include sudden shortness of breath, chest pain, or leg swelling. It is a significant risk in patients with certain heart conditions or after surgery.

Ischemic Stroke – An ischemic stroke happens when a blood clot blocks or narrows an artery leading to the brain, reducing blood flow and oxygen. This can cause brain cells to die, leading to loss of function in the affected area. Symptoms may include sudden numbness, confusion, trouble speaking, or loss of balance. It is the most common type of stroke and requires immediate medical attention to minimize brain damage.

Systemic Thromboembolism – Systemic thromboembolism refers to a condition where a blood clot travels through the bloodstream and lodges in a distant blood vessel, affecting organs such as the brain, kidneys, or limbs. This can lead to organ damage or failure due to restricted blood flow. Symptoms depend on the affected organ and may include pain, dysfunction, or sudden changes in health status. It is often associated with heart conditions that increase clot formation risk.

Valve Thrombosis – Valve thrombosis is the formation of a blood clot on a heart valve, which can impair its function. This condition is more common in patients with mechanical heart valves. Symptoms may include shortness of breath, fatigue, or heart palpitations. It can lead to serious complications if the clot obstructs blood flow or causes valve malfunction. Regular monitoring is essential for individuals with mechanical valves to prevent this condition.

Major Bleeding – Major bleeding is a severe loss of blood that can occur internally or externally, often as a complication of anticoagulant therapy. It can lead to significant health issues, including shock or organ failure, if not managed promptly. Symptoms may include visible bleeding, dizziness, or a drop in blood pressure. It requires immediate medical attention to control the bleeding and stabilize the patient.

Minor Bleeding – Minor bleeding refers to small amounts of blood loss that are usually not life-threatening. It can occur as a side effect of medications like blood thinners. Symptoms may include bruising, nosebleeds, or bleeding gums. While generally not serious, it can be a sign of underlying issues that may need medical evaluation.

Hemorrhagic Stroke – A hemorrhagic stroke occurs when a blood vessel in the brain bursts, causing bleeding in or around the brain. This can lead to increased pressure on brain tissue and damage. Symptoms may include sudden headache, weakness, or loss of consciousness. It is less common than ischemic stroke but can be more severe. Immediate medical intervention is crucial to manage the bleeding and reduce brain injury.

Myocardial Infarction – Myocardial infarction, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked, causing damage to the heart muscle. This is often due to a clot in a coronary artery. Symptoms may include chest pain, shortness of breath, and nausea. It requires urgent medical care to restore blood flow and minimize heart damage.

Pulmonary Embolism – Pulmonary embolism is a blockage in one of the pulmonary arteries in the lungs, usually caused by blood clots that travel from the legs. This can reduce blood flow to the lungs and decrease oxygen levels in the blood. Symptoms may include sudden shortness of breath, chest pain, and coughing. It is a serious condition that requires prompt treatment to prevent complications.

Deep Vein Thrombosis – Deep vein thrombosis (DVT) is the formation of a blood clot in a deep vein, typically in the legs. It can cause pain, swelling, and redness in the affected limb. If a clot breaks free, it can travel to the lungs and cause a pulmonary embolism. Risk factors include prolonged immobility, surgery, and certain medical conditions. Early detection and treatment are important to prevent complications.

New Renal Replacement Therapy – Renal replacement therapy is a treatment for kidney failure that involves filtering waste and excess fluid from the blood. It includes dialysis and kidney transplantation. This therapy is necessary when the kidneys can no longer function adequately on their own. Symptoms of kidney failure may include fatigue, swelling, and changes in urine output. It is a critical intervention for maintaining health in patients with severe kidney disease.

Trial ID:
2023-508532-56-00
Protocol code:
2019.06.26
NCT ID:
NCT03636295
Trial Phase:
Therapeutic confirmatory (Phase III)

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