Prinzmetal angina Trials in Disease

Study on the Effects of Vericiguat on Patients with Vasospastic Angina

This trial is investigating how a medication called Vericiguat affects people who experience chest pain caused by spasms in their heart's blood vessels. The condition, known as Vasospastic Angina or Prinzmetal Angina, occurs when the coronary arteries temporarily narrow due to muscle contractions in the vessel walls, reducing blood flow to the heart.

Main focus and goals: The primary aim of this study is to understand whether Vericiguat can improve the function of small blood vessels in the heart. Researchers will use a specialized imaging technique called Laser Speckle Contrast Analysis to visualize and measure blood flow through these tiny vessels. The trial will also assess whether the medication can improve patients' quality of life and reduce the frequency of chest pain attacks. Different doses of Vericiguat (2.5 mg, 5 mg, and 10 mg) will be tested to determine the most effective amount for improving symptoms.

Who can participate: To join this trial, you must be:

• At least 18 years old
• Experiencing recurring chest pain triggered by exercise or having frequent chest pain attacks at rest at least once per week, despite current treatment
• Free of significant narrowing of the coronary arteries (no artery narrowed by more than 50%)
• Have confirmed coronary vasospasm verified by a specific test called invasive acetylcholine provocation testing
• If female and of childbearing age, willing to use highly effective birth control during the study and for at least one month after completion, and have a negative pregnancy test before starting the medication

Who cannot participate: You will not be able to join this trial if you have:

• Other heart conditions unrelated to vasospastic angina
• Recently experienced a heart attack or other serious heart events
• Severe liver or kidney disease
• Are pregnant or breastfeeding
• Are currently in another clinical trial
• A history of drug or alcohol abuse
• Any condition that makes it difficult to follow study procedures or attend regular visits
• Any health issue that doctors believe would make participation unsafe

Investigational medication: The trial tests Vericiguat, which is taken as film-coated tablets. Vericiguat belongs to a class of drugs called soluble guanylate cyclase stimulators. It works by enhancing a natural pathway in the body that helps blood vessels relax and widen, which may improve blood flow to the heart and reduce chest pain episodes. The medication will be compared to a placebo to properly evaluate its effectiveness.

What happens during the trial: Participation involves a total of 20 weeks divided into two 10-week treatment phases. In the first phase, you will take a placebo (an inactive substance with no medication). In the second phase, you will take Vericiguat. Throughout both phases, you will undergo regular assessments including blood tests, heart function tests, and imaging studies to measure changes in blood vessel function. You will take the medication once daily as instructed by the study team.