ST 상승 심근경색증(STEMI) 환자의 안전성, 내약성 및 유효성을 평가하기 위한 RTP-026의 탐색적, 무작위, 이중 맹검 연구
ST 상승 심근경색(STEMI) 환자의 안전성, 내약성 및 유효성을 평가하기 위한 RTP-026에 대한 탐색적, 무작위, 이중 맹검, 다기관, 위약 대조 연구
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).
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Copenhagen, 덴마크, 2100
- Hjertecenteret, Rigshospitalet
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 위약
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Intervention is for each subject administered as three 30-minutes infusions of placebo |
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실험적: RTP-026
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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; |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Cardiac Troponin T (cTNT)
기간: 24 hours
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Change in cTnT determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI. |
24 hours
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Change in Creatinine kinase-MB (CK-MB)
기간: 24 hours
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Change in CK-MB determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI. |
24 hours
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Thomas Engstrøm, Prof. MD, Hjertecenteret, Rigshospitalet, Denmark
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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