Study on the Effects of T89 and Glyceryl Trinitrate for Patients with Stable Angina

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called T89 for patients with Stable Angina, a condition characterized by chest pain due to reduced blood flow to the heart. The study aims to confirm the effectiveness of T89 in reducing the symptoms of stable angina. T89 is administered in the form of capsules taken orally. Another medication involved in the study is Nitroglycerin, which is used as a sublingual tablet, meaning it is placed under the tongue to dissolve. A placebo, which looks like the real medication but does not contain the active substance, is also used in the study.

The purpose of the study is to confirm the anti-anginal effect of T89 in patients with stable angina. Participants in the study will be randomly assigned to one of three groups: one group will receive T89, another will receive Nitroglycerin, and the third group will receive a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This helps ensure that the results are not biased. The study will take place over a period of several weeks, during which participants will be monitored for changes in their symptoms and any side effects they may experience.

Throughout the study, participants will undergo various assessments to track their progress. These assessments will include measuring the duration of exercise they can perform before experiencing symptoms, as well as monitoring the frequency of angina episodes. The study will also evaluate the safety of T89 by recording any adverse events or notable changes in laboratory tests. The ultimate goal is to determine whether T89 can effectively reduce the symptoms of stable angina and improve the quality of life for those affected by this condition.

1 Initial Screening

The initial screening phase begins 21 days before the trial starts. During this period, eligibility is confirmed based on medical history and current health status.

Patients must have a documented history of coronary artery disease and experience stable angina triggered by physical effort.

Patients are required to undergo two exercise tolerance tests (ETTs) to establish a baseline for angina episodes.

2 Baseline Period

The baseline period lasts from Day -14 to Day 1. During this time, patients must record at least two angina episodes.

Patients are allowed to use short-acting nitroglycerin for relief of angina symptoms.

3 Randomization and Start of Treatment

On Day 1, patients are randomly assigned to one of three groups: T89, glyceryl trinitrate, or placebo.

The treatment involves taking the assigned medication orally or sublingually, depending on the group.

4 Double-blind Treatment Period

The double-blind treatment period extends from Day 1 to Day 57.

Patients continue their assigned medication regimen and record any angina episodes and medication use.

Regular assessments are conducted to monitor the efficacy and safety of the treatment.

5 End of Treatment Assessment

On Day 57, a final assessment is conducted to evaluate changes in exercise tolerance and angina frequency.

The primary endpoint is the change in total exercise duration at trough drug levels.

Who Can Join the Study?

Willing to participate and sign a written informed consent.
If taking certain heart medications like antiplatelet drugs (except aspirin or clopidogrel), statins, ACE inhibitors, angiotensin II receptor blockers (ARB), warfarin, or other direct-acting oral anticoagulants (DOACs), the dose must be stable for at least 2 weeks before the study starts.
Must be between 18 and 90 years old.
Have a history of chronic stable angina, which is chest pain triggered by physical activity and relieved by rest or a medication called sublingual nitroglycerin. The angina should be classified as grade II or III according to the Canadian Cardiovascular Society.
Agree to stop taking certain heart medications, except for one beta blocker or one calcium channel blocker, and be able to continue this treatment plan during the study. If changes are needed, the patient’s heart doctor must agree to them.
Have a documented history of coronary artery disease, which could include a past heart attack (at least 3 months ago), heart disease shown by stress tests, or significant narrowing (50% or more) in heart blood vessels found by imaging tests.
Understand and be willing to follow all study procedures and restrictions, and be able to complete questionnaires and diaries related to angina.
Women who can have children and men with partners who can have children must use effective birth control during the study and for 3 months after the last dose of study medication. Women must have negative pregnancy tests before starting the study.
Must have experienced two or more episodes of angina (chest pain) from 14 days before the study starts to the first day of the study. At least two episodes must be recorded using a specific method, and short-acting nitroglycerin can be used for relief.
Must complete two exercise tolerance tests (ETTs) on specific days before the study starts. These tests measure how long you can exercise, and the results must meet certain criteria.

Who Cannot Join the Study?

Patients who have a different heart condition other than chronic stable angina pectoris cannot participate. Chronic stable angina pectoris is a type of chest pain that happens when the heart doesn’t get enough blood, usually during physical activity or stress.
Patients who are not within the specified age range for the study cannot participate. The study is looking for adults, but the exact age range is not specified here.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship with the study staff, cannot participate.
Patients who do not meet the specific health criteria set by the study, which are not detailed here, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Kardiomed s.r.o.	Lučenec	Slovakia

Other Sites

Site Name	City	Country
Medical Center Hera EOOD	Sofia	Bulgaria
Delta Health Care S.R.L.	Bucharest	Romania
Alian s.r.o.	Bardejov	Slovakia
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie	Lublin	Poland
MBAL Sveti Pantaleimon OOD	Pleven	Bulgaria
American Heart Of Poland S.A.	Kedzierzyn-Kozle	Poland
CardiOR s.r.o.	Trencin	Slovakia
Provita Centrum Medyczne Sp. z o.o.	Tomaszow Mazowiecki	Poland
Neoclinic Concept S.R.L.	Timisoara	Romania
AGEL Clinic s.r.o.	Nove Mesto	Slovakia
Awonyhhl sfrphg	Kysucké Nové Mesto	Slovakia
Mrwvfmx Czhwdf Iwkw Owf	Sofia	Bulgaria
Mgquubq Cjtntg Ayyfjm Icogjrrlsnk Oho	Sofia	Bulgaria
Msjtqkk Cmjcgv Rbol Eqqc	Ruen	Bulgaria
Hsqkjqvt Shxj	Bucharest	Romania
Cmtotwa Msdkgag Tpaopj Syszpv	Targu Mures	Romania
Mjgvkuagp Ijstizzgzq Cesofxxb Sycqjybf Sia z oyby	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Not yet recruiting	24.11.2024
Poland	Not yet recruiting	24.11.2024
Romania	Not yet recruiting	24.11.2024
Slovakia	Not yet recruiting	24.11.2024

Trial locations

Investigated drugs:

T89 is a medication being studied for its potential to relieve symptoms of stable angina, a condition characterized by chest pain due to reduced blood flow to the heart. The trial aims to confirm whether T89 can effectively reduce the frequency and severity of angina attacks, helping patients manage their condition better.

Stable Angina Pectoris – This condition is characterized by chest pain or discomfort that typically occurs with physical exertion or stress. It is caused by reduced blood flow to the heart muscle, often due to narrowed coronary arteries. The pain usually lasts a few minutes and is relieved by rest or medication. Over time, the frequency and intensity of episodes can vary, but the pattern of occurrence remains relatively predictable. It is a chronic condition that can affect daily activities and exercise tolerance. The progression involves managing symptoms and preventing further heart complications.

Trial ID:

2024-512313-41-00

Protocol code:

T89-08-ORESA

NCT ID:

NCT03789552

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of T89 and Glyceryl Trinitrate for Patients with Stable Angina

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