Ongoing Clinical Trials for Chronic Coronary Syndrome
There are currently 6 ongoing clinical trials investigating treatments for chronic coronary syndrome. These studies focus on optimizing antiplatelet therapy strategies following coronary procedures such as stent placement and bypass surgery. The trials are being conducted across multiple European countries and examine various medication approaches to balance effectiveness in preventing blood clots with safety regarding bleeding risks, particularly in older patients and those at high bleeding risk.
Clinical trial locations
- Belgium
- Finland
- France
- Germany
- Italy
- Luxembourg
- Netherlands
- Reduced Dose Prasugrel Monotherapy After Stent Placement in Patients with Acute and Chronic Coronary Syndrome
- Study on Adjusting Clopidogrel and Prasugrel Dosage for Patients with Chronic Coronary Syndrome Based on Body Weight
- Study on the Effects of Ticagrelor and Rivaroxaban in Patients with Atrial Fibrillation After Coronary Stent Surgery
- Poland
- Spain
Study on the Effects of Ticagrelor and Rivaroxaban in Patients with Atrial Fibrillation After Coronary Stent Surgery
This trial focuses on patients with atrial fibrillation who have undergone a coronary stent procedure. It investigates the use of antiplatelet and anticoagulant medications including rivaroxaban, ticagrelor, edoxaban, dabigatran, apixaban, clopidogrel, prasugrel, and acetylsalicylic acid.
Main inclusion criteria: Patients must be 18 years or older with atrial fibrillation requiring treatment with direct-acting oral anticoagulants for at least 12 months. They must have undergone successful percutaneous coronary intervention within the last 7 days, with no additional areas requiring treatment and no major complications following the procedure. Written informed consent is required.
Main exclusion criteria: Patients who have not had a successful coronary procedure, those not indicated for anticoagulant treatment after receiving a stent, those without atrial fibrillation, patients outside the specified age range, and vulnerable populations are excluded.
Study focus: The trial compares a new treatment approach of using a single P2Y12 inhibitor for one month followed by long-term anticoagulant therapy against the standard treatment involving multiple medications. The study monitors patients for up to 15 months, assessing major cardiac or cerebral events such as heart attacks or strokes, as well as bleeding complications. The goal is to determine if the simplified approach is as safe and effective as current standard treatment.
Investigational drugs: P2Y12 inhibitors work by preventing blood platelets from clumping together, reducing clot formation. Direct-acting oral anticoagulants thin the blood to prevent clots and are used after the initial P2Y12 inhibitor treatment phase.
Reduced Dose Prasugrel Monotherapy After Stent Placement in Patients with Acute and Chronic Coronary Syndrome
This study examines the use of a reduced 5 mg dose of prasugrel as the sole antiplatelet medication following coronary stent placement in patients with both acute and chronic forms of coronary disease.
Main inclusion criteria: Patients must have acute coronary syndrome or chronic coronary syndrome and have undergone successful percutaneous coronary intervention with stent placement. They must be able to take prasugrel at the reduced 5 mg dose.
Main exclusion criteria: Patients under 18 years, those with known allergies to prasugrel, history of stroke or mini-stroke, active bleeding or high bleeding risk, severe liver disease, current anticoagulant use, recent heart procedures within 30 days, pregnancy or breastfeeding, life expectancy less than 12 months, or participation in other clinical trials are excluded.
Study focus: The research evaluates whether using a lower dose of prasugrel alone is both feasible and safe after the procedure. Participants are monitored for 12 months for complications including bleeding events and heart-related issues. The study also assesses patient satisfaction with treatment and medication adherence through questionnaires. Blood tests to check platelet reactivity are performed in the first 40 patients at week 2.
Investigational drugs: Prasugrel prevents blood clots by blocking the P2Y12 receptor on platelets, inhibiting their ability to stick together. This study uses a reduced 5 mg daily dose as monotherapy.
Study comparing high-dose and low-dose aspirin with prasugrel and aspirin combination in patients after coronary artery bypass grafting surgery
This trial investigates different medication strategies to prevent graft failure after coronary artery bypass grafting surgery in patients with coronary artery disease.
Main inclusion criteria: Patients must be over 18 years old and scheduled for bypass surgery with at least 2 grafts for stable heart disease. They must have significant narrowing of heart arteries (70% or more, or 50% or more in the main artery), or abnormal blood flow measurements. During surgery, all grafts must show normal blood flow, and an internal thoracic artery graft must be placed to the front heart vessel. Patients must be able to follow all study procedures and sign informed consent.
Main exclusion criteria: History of allergies to aspirin or prasugrel, active bleeding or high bleeding risk, previous stroke or mini-stroke, emergency or urgent surgery, severe liver disease, current use of other blood thinners, recent major surgery within 3 months, blood disorders increasing bleeding risk, scheduled surgery within 3 months after bypass, participation in other trials, inability to attend follow-ups, pregnancy or planning pregnancy, kidney failure requiring dialysis, uncontrolled high blood pressure, and active stomach or intestinal ulcers.
Study focus: The research compares three treatment approaches: low-dose aspirin (75mg) plus prasugrel (10mg), high-dose aspirin (300mg) alone, or low-dose aspirin (75mg) alone for three months following surgery. After this initial period, all patients continue with low-dose aspirin only. The study tracks graft patency and complications over 12 months, evaluating the effectiveness and safety of these different medication combinations.
Investigational drugs: Aspirin makes blood platelets less sticky, reducing clot formation in blood vessels and grafts. Prasugrel is a more potent antiplatelet medication that works alongside aspirin to prevent blood clots and keep surgical grafts open by preventing platelets from sticking together.
Study Comparing Single and Dual Antiplatelet Therapy with Clopidogrel and Acetylsalicylic Acid in Elderly Patients or Those at Risk of Bleeding After Balloon Surgery
This study compares single versus dual antiplatelet therapy in elderly patients or those at high bleeding risk following drug-coated balloon angioplasty to treat narrowed heart vessels.
Main inclusion criteria: Patients must be at least 75 years old or have high bleeding risk. They must have undergone successful drug-coated balloon angioplasty on 1, 2, or 3 heart arteries measuring between 2.0 and 4.0 mm in diameter. The treatment must address new blockages not previously treated, and patients must have either stable or unstable coronary syndromes. Informed consent is required.
Main exclusion criteria: Patients without stable or unstable coronary syndromes treated with successful balloon angioplasty, those who did not undergo drug-coated balloon angioplasty, unsuccessful procedures, inability to complete 12-month follow-up, inability or unwillingness to take required antiplatelet therapy, or any condition making study participation unsafe.
Study focus: The trial compares taking one antiplatelet medication versus taking two medications to prevent blood clots after the balloon procedure. The goal is to determine if single therapy is as effective as dual therapy in preventing complications while potentially reducing bleeding risks. Patients are followed for 12 months, with monitoring for death, need for additional procedures, heart attacks related to treated vessels, and quality of life assessments.
Investigational drugs: Single antiplatelet therapy involves one medication to reduce blood clotting and prevent heart attacks and strokes. Dual antiplatelet therapy combines two different medications providing stronger clot protection. The drug-coated balloon is a device that releases medication to prevent vessels from narrowing again after the procedure.
Study on Adjusting Clopidogrel and Prasugrel Dosage for Patients with Chronic Coronary Syndrome Based on Body Weight
This trial explores whether adjusting clopidogrel dosage based on body weight or Body Mass Index can improve treatment outcomes in patients with the condition.
Main inclusion criteria: Patients must be 18 years or older and currently treated with clopidogrel 75 mg once daily for at least one month. They must also be taking aspirin 100mg once daily. Both men and women can participate, and signed informed consent is required.
Main exclusion criteria: Patients not diagnosed with the condition, those outside the specified age range, vulnerable populations, patients not meeting specific body weight or BMI requirements, and those whose platelet reactivity cannot be measured using the VerifyNow test.
Study focus: The study determines if adjusting clopidogrel dosage based on individual body size improves effectiveness. Patients with low, normal, or high body weight/BMI are included to assess if tailored dosing works better. The trial also compares clopidogrel and prasugrel effects in patients with high body weight/BMI. Monitoring involves measuring blood clotting ability using the VerifyNow test, genetic testing to understand treatment response differences, and tracking major health events like heart attacks, strokes, or bleeding. The study concludes in February 2026.
Investigational drugs: Clopidogrel prevents blood clots by inhibiting platelet aggregation. The trial investigates whether weight-based dosing adjustments can improve its effectiveness, measured through platelet reactivity testing.
Study on the Safety and Effectiveness of Short Dual Antiplatelet Therapy with Ticagrelor, Clopidogrel, and Prasugrel in Patients Aged 65+ with Coronary Artery Disease
This trial focuses on older patients aged 65 and above who have received at least one drug-eluting stent following percutaneous coronary intervention for either acute or chronic coronary conditions.
Main inclusion criteria: Patients must be 65 years or older and have been successfully treated with percutaneous coronary intervention using at least one drug-eluting stent for acute or chronic coronary syndrome. Success is defined as good blood flow with vessel narrowing less than 30%. Randomization must occur before leaving the study site, written informed consent is required, and patients must be affiliated with social security.
Main exclusion criteria: Patients who have not been successfully treated with the coronary procedure, those who have not received at least one drug-eluting stent, patients younger than 65 years, and those not treated for acute or chronic coronary syndrome.
Study focus: The trial compares a very short period of dual antiplatelet therapy followed by single P2Y12 inhibitor therapy against standard longer-duration dual therapy. Medications studied include ticagrelor (Brilique), clopidogrel (Plavix), and prasugrel (Efient), along with aspirin (KARDEGIC). The study monitors patients for up to one year, assessing whether the shorter treatment approach is as effective as standard treatment in preventing death, heart attacks, strokes, and major bleeding while potentially offering safety benefits for this older patient population.
Investigational drugs: P2Y12 inhibitors block a specific receptor on platelets, reducing their ability to stick together and form clots. This is particularly important for patients who have undergone coronary procedures where clot formation risk is higher. The trial evaluates using these medications as single therapy after a brief period of dual therapy.
Summary
These six ongoing clinical trials reflect a concentrated effort to optimize antiplatelet therapy strategies for patients with chronic coronary syndrome, particularly following coronary interventions. A notable pattern is the strong focus on balancing clot prevention effectiveness with bleeding safety, especially in vulnerable populations such as elderly patients and those at high bleeding risk.
The Netherlands appears frequently as a trial location, hosting three studies, while the largest trial spans eight countries across Europe including Germany, France, Netherlands, Italy, Spain, Belgium, Finland, and Poland. This geographic distribution suggests broad European interest in refining treatment approaches for this condition.
Several trials investigate reduced-intensity or shortened antiplatelet therapy regimens, including reduced-dose prasugrel monotherapy, weight-adjusted dosing of clopidogrel, and abbreviated dual therapy periods. This trend indicates a shift toward more personalized, potentially safer treatment approaches while maintaining effectiveness in preventing cardiovascular events.
The medications most frequently studied include prasugrel, clopidogrel, ticagrelor, and aspirin in various combinations and dosing strategies. Some trials also examine the integration of anticoagulants with antiplatelet therapy, particularly in patients with atrial fibrillation who face dual risks requiring careful medication balance.
