Ongoing Clinical Trials for Aortic Valve Stenosis
There are currently 6 clinical trials investigating new treatments and approaches for aortic valve stenosis. These studies are exploring medications to slow disease progression, optimal blood-thinning strategies after valve replacement procedures, and safer sedation methods during treatment. Trials are taking place across multiple European countries including Belgium, Netherlands, France, Denmark, Germany, Austria, Italy, Spain, Portugal, Czechia, and Norway.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- France
- Study on Pelacarsen for Slowing Calcific Aortic Valve Stenosis in Patients
- Study on Personalized Antithrombotic Therapy with Acenocoumarol, Phenprocoumon, and Apixaban for Patients with Aortic Valve Stenosis Post-TAVI
- Study on Short vs. Long Antiplatelet Therapy with Aspirin for Adults After TAVI for Symptomatic Aortic Stenosis
- Germany
- Italy
- Netherlands
- Study on Pelacarsen for Slowing Calcific Aortic Valve Stenosis in Patients
- Study on Personalized Antithrombotic Therapy with Acenocoumarol, Phenprocoumon, and Apixaban for Patients with Aortic Valve Stenosis Post-TAVI
- Study on Icosapent Ethyl for Slowing Aortic Valve Stenosis Progression in Patients with Aortic Valve Stenosis
- Norway
- Portugal
- Spain
Study on Pelacarsen for Slowing Calcific Aortic Valve Stenosis in Patients
This trial is investigating whether pelacarsen, an experimental medication, can slow down the progression of calcific aortic valve stenosis. This condition occurs when calcium builds up on the heart valve, making it narrower and harder for blood to flow properly.
Who can participate: Adults between 50 and 79 years old with mild or moderate stenosis can join. Participants must have elevated lipoprotein(a) levels of 175 nmol/L or higher and already be receiving optimal treatment for cardiovascular risk factors like high cholesterol, diabetes, and high blood pressure.
Who cannot participate: People with severe allergic reactions to the medication, other serious heart conditions, recent heart attack or stroke within six months, uncontrolled high blood pressure, severe kidney or liver disease, pregnant or breastfeeding women, and those participating in other trials are excluded.
What the trial involves: Participants receive regular injections of either pelacarsen or placebo over 36 months. The medication is designed to lower lipoprotein(a), a protein linked to disease progression. Throughout the study, heart function is monitored using echocardiography and CT scans to measure changes in valve function and calcium buildup.
Investigational drug: Pelacarsen (also called TQJ230) is an antisense oligonucleotide that works by reducing lipoprotein(a) levels in the blood. It is given as 80 mg subcutaneous injections using pre-filled syringes.
Study on Personalized Antithrombotic Therapy with Acenocoumarol, Phenprocoumon, and Apixaban for Patients with Aortic Valve Stenosis Post-TAVI
This study compares two approaches to preventing blood clots after transcatheter aortic valve implantation (TAVI), a procedure that replaces a narrowed heart valve without open-heart surgery. One approach uses personalized treatment guided by CT scans, while the other uses standard lifelong single antiplatelet therapy.
Who can participate: Patients who have successfully undergone TAVI, can understand and follow the study protocol, and have provided written consent can join. Both men and women are eligible.
Who cannot participate: Those with a history of aortic valve stenosis before the procedure, existing need for oral anticoagulation therapy, or belonging to vulnerable populations are excluded.
What the trial involves: Participants are randomly assigned to receive either personalized CT-guided antithrombotic therapy or standard single antiplatelet therapy. The medications include acenocoumarol, phenprocoumon, prasugrel, apixaban, clopidogrel, warfarin, ticagrelor, and acetylsalicylic acid, taken orally as tablets. Regular follow-ups include health monitoring, yearly echocardiography, and quality of life assessments until 2027.
Investigational drugs: Various oral anticoagulant and antiplatelet medications are being tested to determine the most effective strategy for preventing blood clots and bleeding after valve replacement.
Study on Sedation During Transcatheter Aortic Valve Replacement in Patients with Aortic Stenosis Using Remifentanil, Dexmedetomidine, and Propofol
This trial examines different sedation medications used during TAVI procedures to determine which options result in fewer complications like respiratory acidosis (too much carbon dioxide in the blood) and emergence delirium (confusion after waking from sedation).
Who can participate: Adults aged 18 to 95 years undergoing TAVI who can provide informed consent are eligible.
Who cannot participate: The study does not list specific exclusion criteria beyond the standard requirements.
What the trial involves: Participants receive one of several sedation medications during their TAVI procedure, including remifentanil, propofol, and ketamine, administered through infusion. Vital signs and sedation levels are closely monitored during the procedure, and patients are observed for 24 hours afterward to check for respiratory issues or confusion. The study measures how quickly patients reach the desired sedation level and when they meet discharge criteria.
Investigational drugs: Propofol, dexmedetomidine, and midazolam are being compared for their safety and effectiveness as sedatives during valve replacement procedures.
Study on Short vs. Long Antiplatelet Therapy with Aspirin for Adults After TAVI for Symptomatic Aortic Stenosis
This French trial compares two durations of aspirin treatment after TAVI: a shorter 3-month course versus the standard 12-month treatment. The goal is to determine if shorter treatment is equally effective at preventing complications.
Who can participate: Adults 18 years or older who have had successful transfemoral TAVI for symptomatic stenosis can join. Participants must be French-speaking, affiliated with social security, and provide written consent. Women must be post-menopausal or permanently sterilized.
Who cannot participate: Those who did not have successful transfemoral TAVI or who need long-term antiplatelet or anticoagulant therapy for other medical reasons are excluded.
What the trial involves: After successful TAVI, participants are randomly assigned to take aspirin for either 3 or 12 months. The medication comes in two forms: KARDEGIC 75 mg powder for oral solution or ASPIRINE PROTECT 100 mg gastro-resistant tablets, taken daily. Participants are followed for 12 months with regular check-ups monitoring for heart attacks, strokes, bleeding events, and overall quality of life.
Investigational drug: Aspirin is an antiplatelet medication that prevents blood clots by stopping platelets from sticking together. The trial tests whether a shorter treatment period is as safe and effective as longer treatment.
Study on Icosapent Ethyl for Slowing Aortic Valve Stenosis Progression in Patients with Aortic Valve Stenosis
This Dutch trial investigates whether icosapent ethyl, an omega-3 fatty acid medication, can slow calcium buildup in the aortic valve over 24 months.
Who can participate: Men and women over 50 years old with mild to moderate stenosis are eligible.
Who cannot participate: People with other heart conditions besides stenosis, recent heart surgery within 6 months, severe kidney disease, participation in other trials, pregnancy or breastfeeding, severe fish or shellfish allergies, uncontrolled high blood pressure, recent alcohol or drug abuse, or other serious medical conditions are excluded.
What the trial involves: Participants take Vazkepa 998 mg soft capsules containing icosapent ethyl by mouth. Regular assessments monitor changes in valve calcium levels, blood flow speed through the valve, valve opening size, and plaque buildup in heart arteries. The study runs until June 2026.
Investigational drug: Icosapent ethyl is an omega-3 fatty acid derivative that may help reduce inflammation and slow calcium buildup in the heart valve.
Study on Blood Thinners Apixaban, Edoxaban, Rivaroxaban, and Acetylsalicylic Acid for Patients with Aortic Stenosis After Heart Valve Replacement
This Norwegian study compares different blood-thinning medications to find the safest and most effective treatment for preventing blood clots and bleeding after TAVI.
Who can participate: Adults aged 65 to 80 who have had successful TAVI, signed informed consent, and can follow the study protocol are eligible.
Who cannot participate: People with severe bleeding disorders, recent stroke, active infections, severe kidney or liver disease, participation in other trials, pregnancy or breastfeeding, known medication allergies, uncontrolled high blood pressure, or severe heart failure cannot join.
What the trial involves: Participants are randomly assigned to receive one of several blood thinners (apixaban, edoxaban, rivaroxaban, or acetylsalicylic acid) or possibly placebo. All medications are taken orally as directed. Regular check-ups monitor health, medication effects, and any side effects throughout the trial period of up to 12 months.
Investigational drugs: The study tests various anticoagulants and acetylsalicylic acid (aspirin) to determine which best prevents blood clots while minimizing bleeding risks after valve replacement.
Summary
These six clinical trials represent a comprehensive approach to improving treatment for aortic valve stenosis across Europe. A notable pattern is the concentration of research in Western and Northern European countries, with multiple trials taking place in the Netherlands, Germany, France, Belgium, and Denmark.
Two main areas of investigation emerge from these studies. First, several trials focus on slowing disease progression before valve replacement becomes necessary, testing medications like pelacarsen and icosapent ethyl that target calcium buildup. Second, multiple studies address optimal care after TAVI procedures, particularly examining different blood-thinning strategies to balance the risks of clots versus bleeding.
The personalized medicine approach is prominent in several trials, with treatments tailored to individual patient needs based on CT scans and other assessments. Additionally, practical questions about treatment duration are being addressed, such as whether shorter courses of aspirin after TAVI might be as effective as longer treatments.
These trials reflect ongoing efforts to improve both conservative management and procedural outcomes for patients with this progressive heart valve condition. Results from these studies may help doctors make more informed decisions about treatment timing, medication choices, and duration of therapy.
