CRUSHed vs. Uncrushed Prasugrel in STEMI Patients Undergoing PCI

Maasstad Hospital729 enrolled

Overview

The studys evaluates the effect of prehospital administration of crushed tablets of Prasugrel loading dose (in addition to ASA and standard care) versus uncrushed tablets of Prasugrel loading dose on efficacy and safety as well as pharmacodynamics as measured by platelet reactivity using VerifyNow.

The study is a two-centre, randomized, 1:1 trial comparing prehospital prasugrel initiation therapy between crushed vs. uncrushed prasugrel tablets on efficacy and safety as well as pharmacodynamics in STEMI patients. Patients with STEMI planned for primary PCI will be screened and, if inclusion criteria are met, included at first medical contact (paramedics). After enrolment, patients will be randomly assigned (1:1) to receive 60mg prasugrel loading dose by ingesting integral or crushed tablets. The follow-up duration is 12 months, i.e. clinical outcomes will be analysed in-hospital, at 30 days, and 12 months

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

729

Conditions

Cardiovascular Diseases

Interventions

Prasugrel (Crushed tablets)DRUG

loading dose of 6 crushed tablets 10mg Prasugrel

Prasugrel (Integral tablets)DRUG

loading dose of 6 integral tablets of 10mg Prasugrel

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Consecutive patients with STEMI planned for primary PCI: * Deferred written informed consent within 4 hours after prasugrel loading dose * Adult men and women aged at least 18 years * Symptoms of acute MI of more than 30 min but less than 6 hours * New persistent ST-segment elevation ≥ 1 mm in two or more contiguous ECG leads Exclusion Criteria: * Contraindication to prasugrel (e.g., hypersensitivity, active bleeding, history of previous intracranial bleed, history of any CVA including TIA, moderate to severe hepatic impairment, GI bleed within the past 6 months, major surgery within past 4 weeks) * Patient who has received loading dose of clopidogrel or ticagrelor for the index event or are on chronic treatment of ticagrelor, or prasugrel. However, patients on maintenance dose clopidogrel for at least 7 days are included in the study (see appendix A). * Oral anticoagulation therapy that cannot be stopped (i.e. patients requiring chronic therapy) * Planned fibrinolytic treatment * Patient requiring dialysis * Known, clinically important thrombocytopenia * Known clinically important anaemia * Known pregnancy or lactation * Need for a concomitant systemic therapy with strong inhibitors or strong inducers of CYP3A * Condition which may either put the patient at risk or influence the result of the study (e.g., cardiogenic shock with severe hemodynamic instability, active cancer, risk for non-compliance, risk for being lost to follow up) * Patient unable to swallow oral medication (i.e. intubated patients) * Patient who have not received prasugrel loading dose in the ambulance * Patient who vomited after randomization / receiving the loading dose prasugrel

Locations (2)

Erasmus Medical Center

Rotterdam, Netherlands

Maasstadziekenhuis

Rotterdam, Netherlands

Outcomes

Primary Outcomes

Co-primary endpoint is the percentage of patients reaching TIMI flow grade 3 of MI culprit vessel at initial angiography or a ≥70% ST-segment resolution directly post-PCI

To assess the efficacy of crushed vs. integral tablets of prasugrel loading dose treatment by comparing the percentage of patients reaching the co-primary endpoint of TIMI flow grade 3 of MI culprit vessel at initial angiography or a ≥70% ST-segment elevation resolution directly post-PCI.

Time frame: directly post PCI

Secondary Outcomes

Composite of death, MI, stroke, urgent revascularization and acute stent thrombosis in hospital, at 30 days and 12 months

Percentage of patients in the following: composite of death, MI, stroke, urgent revascularization and acute stent thrombosis during inhospital stay, 30 days and 12 months of study

Time frame: upto 72 hours after randomisation, at 30 days and 12 months.

Composite of death, MI, urgent revascularization during inhospital, at 30 days and 12 months of study

Percentage of patients in the following: composite of death, MI, or urgent revascularization during inhospital, 30 days and 12 months of study

Time frame: 30 days and 12 months

Individual endpoints during inhospital, at 30 days and 12 months of study

Percentage of patients presenting with any of the individual endpoints during inhospital, 30 days and 12 months of study

Time frame: upto 72 hours after randomisation, at 30 days and 12 months.

Thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI

Percentage of patients receiving thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI

Time frame: directly post PCI

Complete (≥ 70%) ST-segment elevation resolution pre-PCI and 60 min post-PCI

Data from ClinicalTrials.gov

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