A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)
Recruiting
Phase 2Interventional Study
ST Elevation Myocardial Infarction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
96 (estimated)
Sponsor
ResoTher Pharma · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 …
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.