ST上昇型心筋梗塞（STEMI）患者における安全性、忍容性、有効性を評価するためのRTP-026の探索的ランダム化二重盲検研究
ST上昇型心筋梗塞（STEMI）患者における安全性、忍容性、有効性を評価するためのRTP-026の探索的、無作為化、二重盲検、多施設プラセボ対照試験
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).
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Copenhagen、デンマーク、2100
- Hjertecenteret, Rigshospitalet
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：プラセボ
|
Intervention is for each subject administered as three 30-minutes infusions of placebo |
|
実験的：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; |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Cardiac Troponin T (cTNT)
時間枠：24 hours
|
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
|
|
Change in Creatinine kinase-MB (CK-MB)
時間枠：24 hours
|
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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Thomas Engstrøm, Prof. MD、Hjertecenteret, Rigshospitalet, Denmark
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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