ST Elevation Myocardial Infarction
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGRTP-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;
DRUGPlacebo
Intervention is for each subject administered as three 30-minutes infusions of placebo
Sponsors
ResoTher Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiac Troponin T (cTNT) | 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. |
| Change in Creatinine kinase-MB (CK-MB) | 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. |
Countries
Denmark
Contacts
Primary ContactIrene Sandholdt
Backup ContactSamra J Sanni, PhD
Outcome results
None listed