Antiplatelet treatment with Cangrelor in patients presenting with myocardial infarctio

Phase 1

• Conditions: ST-Elevation Myocardial Infarction; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-005149-18-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-01
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients with out-of-hospital ST-elevation myocardial infarction
• male or non-pregnant female, aged between 18 and 74
• hemodynamically stable, Killip class I
• planned to undergo primary percutaneous coronary intervention (PCI)
• PCI available < 120 min
• pretreatment with morphine
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

• bodyweight < 50kg or > 99kg
• known intolerance or allergy to cangrelor or another P2Y12 receptor inhibitor
• active bleeding or increased risk of bleeding because of known coagulation or
platelet disorders
• previous hemorrhagic stroke, under oral anticoagulant therapy, moderate to
severe liver disease
• pregnancy or active breastfeeding
• intake of clopidogrel, prasugrel or ticagrelor in the past 14 days
• patient in a palliative setting OR life expectancy < 1 year

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study tries to find an improved treatment concept of preclinical antiplatelet treatment in the acute setting of ST-elevation myocardial infarction.;Secondary Objective: Further, this study evaluates the safety, efficacy and feasibility of preclinical antiplatelet treatment with cangrelor in the acute setting of ST-elevation myocardial infarction.;Primary end point(s): The rate of HTPR at the time of emergency department admission defined as ADP-induced platelet activation > 46 U (measured by MEA analysis) in the intervention group vs. the placebo group.<br>Primary safety outcome: major bleeding at 30 days according to the TIMI and BARC (3-5) bleeding definition<br><br>Primary safety endpoint: in-hospital major bleeding according to the TIMI and BARC (3-5) bleeding definition (1);Timepoint(s) of evaluation of this end point: admission to the emergency department <br>hospital follow-up