Study on the Safety and Effectiveness of RTP-026 for Patients with ST-Elevation Myocardial Infarction (STEMI)

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What is this study about?

This clinical trial is focused on studying a heart condition known as ST-Elevation Myocardial Infarction (STEMI), which is a type of heart attack. The study will evaluate a treatment called RTP-026, which is given as a solution through an intravenous infusion. The purpose of the study is to assess the safety, tolerability, and effectiveness of RTP-026 in patients who have experienced a STEMI.

Participants in the study will receive either the RTP-026 treatment or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The study will take place over a period of time, with multiple doses being administered to evaluate how well the treatment works and how safe it is for the patients.

Throughout the study, various health checks will be conducted, including monitoring vital signs, performing ECGs (electrocardiograms), and taking blood samples to measure specific markers related to heart health. The study aims to gather information on how RTP-026 affects the heart and overall recovery after a STEMI, with the goal of improving treatment options for this serious condition.

1 joining the study

Participation begins after providing informed consent. This is a necessary step before any study-specific procedures can start.

2 initial assessment

Eligibility is confirmed based on criteria such as age, gender, and specific medical conditions related to ST-Elevation Myocardial Infarction (STEMI).

An initial evaluation includes an electrocardiogram (ECG) to confirm STEMI and other tests to ensure eligibility for primary percutaneous coronary intervention (PCI).

3 treatment administration

The treatment involves receiving RTP-026 or a placebo through an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

The primary goal is to assess the safety and effectiveness of RTP-026 compared to a placebo.

4 monitoring and follow-up

Regular monitoring includes checking for any adverse events, changes in vital signs, and conducting ECGs and laboratory tests.

Blood samples are taken at baseline, 6 hours, 12 hours, and 24 hours after PCI to measure specific markers like cTnT and CK-MB.

5 imaging and further assessments

Cardiac magnetic resonance (CMR) imaging is performed within 48 hours and again 90 days after PCI to assess heart function and damage.

Additional blood tests are conducted to measure changes in markers such as Pro-BNP, hsCRP, and NLR.

6 final evaluation

The study concludes with a final assessment of the treatment’s impact on heart function and overall health.

The primary and secondary endpoints are evaluated, including safety, tolerability, and any major adverse cardiac events (MACE).

Who Can Join the Study?

The patient must give their permission to join the study before any study-related activities begin.
The patient must be a man between 18 and 80 years old or a woman who has stopped having menstrual periods for at least 12 months and is up to 80 years old.
The patient must have had sudden chest pain for less than 12 hours.
The patient must have a specific type of heart attack called ST-Elevation Myocardial Infarction (STEMI), which is identified by certain patterns on an ECG (a test that checks the heart’s electrical activity).
The patient must be eligible for a procedure called primary PCI, which is a treatment to open blocked heart arteries.
The patient must have a NLR (a type of blood test result) between 7 and 17 when they arrive at the hospital or right after the PCI procedure.

Who Cannot Join the Study?

Patients who have had a recent ST-Elevation Myocardial Infarction (STEMI), which is a type of heart attack.
Individuals who are not within the specified age range for the study.
Participants who are part of a vulnerable population, meaning they might be at higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Rigshospitalet	Copenhagen	Denmark
Lund University Hospital	Lund	Sweden
Aawvda Uaawulhdvn Hgskosbt	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.05.2024
Sweden	Not recruiting	01.05.2024

Trial locations

Investigated drugs:

Rtp-026 Sodium

RTP-026 is a medication being studied for its safety, tolerability, and effectiveness in patients who have experienced a type of heart attack known as ST-Elevation Myocardial Infarction (STEMI). The trial aims to understand how well RTP-026 works in helping patients recover from this condition and to ensure that it is safe for use.

Investigated diseases:

Acute myocardial infarction

ST-Elevation Myocardial Infarction (STEMI) – This is a type of heart attack characterized by a significant elevation in the ST segment on an electrocardiogram (ECG). 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. Symptoms often include chest pain, shortness of breath, and discomfort in other areas of the upper body. The progression of the disease can lead to complications such as heart failure or arrhythmias if not addressed promptly. Immediate medical intervention is crucial to restore blood flow and minimize heart damage.

Trial ID:

2023-509182-21-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of RTP-026 for Patients with ST-Elevation Myocardial Infarction (STEMI)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?