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Study on Dabigatran and Phenprocoumon for Treating Left Ventricular Thrombosis After Heart Attack in Patients with STEMI

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of two heart-related conditions: ST-elevation myocardial infarction (STEMI), which is a type of heart attack, and left ventricular thrombosis, which is a blood clot in the heart's left ventricle. The study will use two medications: dabigatran etexilate, known by the brand name Pradaxa, and phenprocoumon, known by the brand name Marcoumar. These medications are used to prevent blood clots, and the study aims to see how well they work in resolving blood clots in the heart after a STEMI.

The purpose of the study is to estimate how many patients experience the resolution of the blood clot in the heart and whether they have any new brain infarctions, which are areas of dead tissue due to lack of blood supply, after three months of treatment. The study will compare the effects of dabigatran etexilate and phenprocoumon over a period of three months. Some participants will receive a placebo, which is a substance with no active medication, to help compare the effects of the actual medications.

Participants in the study will take the medication or placebo for up to three months. During this time, they will be monitored for any changes in their condition, including the resolution of the blood clot and any new brain infarctions. The study will also track any bleeding events that occur during the treatment period and for up to one year afterward. This information will help researchers understand the effectiveness and safety of these treatments for patients with left ventricular thrombosis after a STEMI.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after providing written consent and meeting specific criteria, such as being diagnosed with STEMI (a type of heart attack) and having a clinical risk score for left ventricular thrombus greater than 2 points.
Eligibility requires being 18 years or older and having a kidney function (eGFR) greater than 30 ml/min/1.73m².
Step 2
Initial treatment phase
The treatment involves taking either dabigatran etexilate or phenprocoumon orally. Dabigatran is available in 110 mg and 150 mg hard capsules, while phenprocoumon is provided in tablet form.
The goal is to resolve the thrombus in the left ventricle after a heart attack.
Step 3
Three-month evaluation
After three months of treatment, an evaluation is conducted to check for thrombus resolution and any new brain infarctions, which are strokes that may not show symptoms.
This evaluation includes a screening MRI to detect any 'silent' brain infarctions.
Step 4
Twelve-month follow-up
A follow-up is conducted to monitor the incidence of brain infarctions and any bleeding events over a twelve-month period.
The study uses specific criteria to assess bleeding events during the active study period and the follow-up.

Who can join the trial?

7 criteria

Patients must have been diagnosed with STEMI, which stands for ST elevation myocardial infarction, a type of heart attack.
Patients must have undergone PCI, which is a procedure called percutaneous coronary intervention, to open blocked heart arteries.
The LAD, or left anterior descending artery, must be the blocked artery causing the heart attack.
Patients must have a clinical risk score for LV-Thrombus greater than 2 points. LV-Thrombus refers to a blood clot in the left ventricle of the heart.
Patients must be 18 years old or older.
Patients must provide written informed consent, meaning they agree to participate in the study after understanding what it involves.
Patients must have an eGFR greater than 30 ml/min/1.73m². eGFR is a test that measures how well the kidneys are working.

Who cannot join the trial?

8 criteria

Patients who have a history of **allergic reactions** to the medications being tested cannot participate. An allergic reaction is when your body reacts badly to something, causing symptoms like a rash, itching, or trouble breathing.
Patients with **severe kidney problems** are excluded. This means if your kidneys, which help clean your blood, are not working well, you cannot join.
Patients with **active bleeding disorders** cannot participate. This means if you have a condition that makes you bleed easily or have trouble stopping bleeding, you are not eligible.
Patients who are **pregnant or breastfeeding** are not allowed to join. This is to ensure the safety of both the mother and the baby.
Patients who have had a **recent major surgery** are excluded. Major surgery is a big operation that usually requires a hospital stay.
Patients with **uncontrolled high blood pressure** cannot participate. This means if your blood pressure, which is the force of your blood against your blood vessels, is too high and not managed well, you cannot join.
Patients with a history of **stroke** or **heart attack** in the last 6 months are excluded. A stroke is when blood flow to your brain is blocked, and a heart attack is when blood flow to your heart is blocked.
Patients who are currently participating in another clinical trial are not eligible. This is to avoid any interference with the study results.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Responsive
Klagenfurt am Wörthersee, Austria
Medical University Of Graz
Verified
Graz, Austria
Medical University Of Vienna
Verified
Vienna, Austria

Trial locations

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Investigated drugs

Dabigatran
is a medication used in this trial to help dissolve blood clots in the heart after a heart attack. It works by inhibiting a specific protein in the blood that is involved in clot formation, which helps prevent new clots from forming and existing clots from getting bigger.
Phenprocoumon
is another medication used in the trial for the same purpose as Dabigatran. It is a type of blood thinner that helps prevent the formation of harmful blood clots by reducing the ability of the blood to clot. This can help reduce the risk of complications after a heart attack.

What is already known about the treatment

Dabigatran
Dabigatran is an oral medication used to prevent blood clots by inhibiting thrombin, an enzyme involved in blood clot formation. It is currently being studied in clinical trials for its effectiveness in resolving blood clots in the heart's left ventricle following a heart attack, specifically STEMI. Dabigatran is classified as a direct thrombin inhibitor and works by blocking the activity of thrombin, thereby reducing the risk of clot formation. It is commonly used for conditions requiring anticoagulation, such as atrial fibrillation and deep vein thrombosis.
Phenprocoumon
Phenprocoumon is an oral anticoagulant that belongs to the class of vitamin K antagonists, which work by reducing the production of clotting factors in the liver. It is being evaluated in clinical trials for its role in resolving left ventricular thrombus after a heart attack, particularly STEMI. Phenprocoumon is well-established in medical practice for preventing and treating blood clots in various conditions, including atrial fibrillation and venous thromboembolism. Its mechanism involves inhibiting vitamin K-dependent clotting factors, thereby preventing clot formation.

Investigated diseases

ST-Elevation Myocardial Infarction (STEMI)
This is a type of heart attack characterized by a significant elevation in the ST segment on an electrocardiogram. It occurs when a coronary artery is completely blocked, preventing blood from reaching a part of the heart muscle. As a result, the affected heart tissue begins to die due to lack of oxygen. The progression of STEMI can lead to severe damage to the heart muscle if not addressed promptly. Symptoms often include chest pain, shortness of breath, and other signs of cardiac distress. Over time, the heart's ability to pump blood effectively may be compromised.
Left Ventricular Thrombosis
This condition involves the formation of a blood clot within the left ventricle of the heart. It often occurs after a heart attack, such as STEMI, when the heart muscle is damaged and blood flow is disrupted. The clot can impede normal blood flow and may lead to complications if it dislodges and travels to other parts of the body. As the condition progresses, it can increase the risk of stroke or other embolic events. The presence of a thrombus can also affect the heart's pumping efficiency. Monitoring and management are crucial to prevent further complications.