A Phase 2 Open Label Study to Assess the PK/PD Properties of RUC-4 in Patients With a ST-elevation Myocardial Infarction
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 24
Summary
- Conditions
- Coronary Disease
- Heart Diseases
- Myocardial Infarction
- STEMI - ST Elevation Myocardial Infarction
- Vascular Diseases
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
RUC-4 is a novel, promising and fast acting (5-15 minutes) ?IIb?3 receptor antagonist with a high-grade inhibition of platelet aggregation (?80%) shortly after subcutaneous administration. For patients with ST-elevation myocardial infarction (STEMI) early treatment with RUC-4 could be beneficial by ...
RUC-4 is a novel, promising and fast acting (5-15 minutes) ?IIb?3 receptor antagonist with a high-grade inhibition of platelet aggregation (?80%) shortly after subcutaneous administration. For patients with ST-elevation myocardial infarction (STEMI) early treatment with RUC-4 could be beneficial by improving initial patency of the infarct related vessel and by minimizing thrombotic occlusions, thus improving both coronary artery and myocardial microvascular blood flow, possibly resulting in a decrease in infarct size and a reduction in complications of STEMI. The purpose of this study is to assess the PD and PK properties of a single subcutaneous injection of RUC-4 in STEMI patients presenting to the cardiac catheterization laboratory with planned coronary angioplasty. In addition the safety and tolerability will be assessed at baseline and hospital discharge.
Tracking Information
- NCT #
- NCT04284995
- Collaborators
- ST. Antonius hospital Nieuwegein
- Diagram B.V.
- Investigators
- Not Provided