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Идёт набор NCT06465303

A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)

Фаза II С лечением ST Elevation Myocardial Infarction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: RTP-026, Placebo.
Кому может быть актуально
Состояния в реестре: ST Elevation Myocardial Infarction. Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
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Официальное название

An Exploratory, Randomised, Double-blind, Multicentre, Placebo-controlled Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)

Обзор

This is an exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026. The study population will consist of men and women with documented evidence of ST-elevation myocardial infarction (STEMI) referred to primary Percutaneous Coronary Intervention (PCI).

Подробное описание

An exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026 to assess safety, tolerability, and efficacy in patients with (STEMI).

The study population is men between 18-85 years and post-menopausal women up to 85 years with documented evidence of STEMI referred to primary PCI with acute onset of chest pain lasting \<12 hours and neutrophil to lymphocyte ratio (NLR) in the range of 3-17 at hospital admission (Please refer to inclusion criteria).

The participants will be given three 30-minute intravenous infusions of RTP-026 or placebo (the investigational product). The first dose is to be initiated within 2 hours following the establishment of reflow after PCI, and the following two study treatments with 8-hour intervals.

The purpose of this study is to evaluate the safety, tolerability and efficacy of RTP-026 versus placebo in multiple doses.

Вмешательства

  • Препарат RTP-026
    Intervention is for each subject administered as three 30-minutes infusions of either A: 25μg/kg RTP-026; or B: ≥ 26μg/kg and ≤75μg/kg RTP-026; or C: A maximum of 3 x treatment dose RTP-026 as given in B;
  • Препарат Placebo
    Intervention is for each subject administered as three 30-minutes infusions of placebo

Первичные конечные точки

  • Change in Cardiac Troponin T (cTNT) [Срок оценки: 24 hours]
  • Change in Creatinine kinase-MB (CK-MB) [Срок оценки: 24 hours]

Критерии участия

Критерии включения

  • Informed consent for participation in the study has been obtained prior to initiating any study-specific procedures
  • Men between 18-85 years of age and post-menopausal women up to 85 years of age
  • Acute onset of chest pain of < 12 hours duration
  • STEMI as characterized on ECG by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with a minimum of 1 mm concordant ST elevation or 1 mV ST elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior acute myocardial infarction (AMI)
  • Eligible for primary PCI
  • NLR in the range of 7-17 at hospital admission. In patients with chest pain lasting > 3 - ≤ 6 hours at admission, the NLR should be in the range of 4.8-17 and for patients with chest pain lasting ≤ 3 hours at admission, the NLR should be in the range of 4.8-17, or the neutrophile count should be ≥ 9 x 10E9/L, irrespective of the lymphocyte count. For STEMI patients with an anterior or anterolateral infarction, the NLR should be ≥3.

Критерии исключения

  • Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry
  • Previous exposure to RTP-026
  • Time from symptoms onset to primary PCI > 12 hours
  • Previous CABG
  • Evidence of active malignant disease
  • Ongoing treatment with immune suppressive compounds
  • Any condition that, in the view of the investigator, would suggest that the patient is unable to comply with the study protocol and procedures
  • Known contraindications to CMR
  • ORBI Risk Score > 12

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Дания · 1 центр
  • Hjertecenteret, Rigshospitalet — Copenhagen

Идентификаторы

NCT: NCT06465303 · ResoTher-CS002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗