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RECRUITINGPhase 2INTERVENTIONAL

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

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - willing to sign a consent form 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

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;

DRUG

Placebo

Intervention is for each subject administered as three 30-minutes infusions of placebo

Locations (1)

Hjertecenteret, Rigshospitalet
Copenhagen, Denmark