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CRUSHed vs. Uncrushed Prasugrel in STEMI Patients Undergoing PCI (CompareCrush)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03296540
Recruitment Status : Completed
First Posted : September 28, 2017
Last Update Posted : May 7, 2021
Sponsor:
Collaborators:
MicroPort Orthopedics Inc.
Daiichi Sankyo, Inc.
Research Maatschap Cardiologen Rotterdam Zuid
Information provided by (Responsible Party):
Maasstad Hospital

Tracking Information
First Submitted Date  ICMJE September 6, 2017
First Posted Date  ICMJE September 28, 2017
Last Update Posted Date May 7, 2021
Actual Study Start Date  ICMJE November 28, 2017
Actual Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2017)
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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2017)
  • Composite of death, MI, stroke, urgent revascularization and acute stent thrombosis in hospital, at 30 days and 12 months [ Time Frame: upto 72 hours after randomisation, 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
  • Composite of death, MI, urgent revascularization during inhospital, at 30 days and 12 months of study [ Time Frame: 30 days and 12 months ]
    Percentage of patients in the following: composite of death, MI, or urgent revascularization during inhospital, 30 days and 12 months of study
  • Individual endpoints during inhospital, at 30 days and 12 months of study [ Time Frame: upto 72 hours after randomisation, at 30 days and 12 months. ]
    Percentage of patients presenting with any of the individual endpoints during inhospital, 30 days and 12 months of study
  • Thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI [ Time Frame: directly post PCI ]
    Percentage of patients receiving thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI
  • Complete (≥ 70%) ST-segment elevation resolution pre-PCI and 60 min post-PCI [ Time Frame: pre-PCI and 60 min post-PCI ]
    Complete (≥ 70%) ST-segment elevation resolution pre-PCI and 60 min post-PCI
  • Corrected TIMI frame count (cTFC) at angiography, pre and post PCI. [ Time Frame: pre PCI, directly post PCI ]
    Corrected TIMI frame count (cTFC) at angiography, pre and post PCI
  • TIMI myocardial perfusion grade (TMPG) at angiography, pre and post PCI. [ Time Frame: pre PCI, directly post PCI ]
    TIMI myocardial perfusion grade (TMPG) at angiography, pre and post PCI.
  • Time-relationship (from symptom onset to 1st dose intake) on each co-primary [ Time Frame: directly post-PCI ]
    Time from symptom onset to 1st dose intake correlated to TIMI flow grade 3 of MI culprit vessel at initial angiography and on ≥70% ST-segment elevation resolution directly post-PCI
  • Time-relationship (from 1st dose intake to ECG/ angiography) on each co-primary [ Time Frame: directly post-PCI ]
    Time from first dose intake to ECG correlated to ≥70% ST-segment elevation resolution directly post-PCI and time from randomization to initial angiography correlated to TIMI flow grade 3 of MI culprit vessel
  • TIMI flow grade 3 at end of procedure. [ Time Frame: directly post PCI ]
    TIMI flow grade 3 at end of procedure.
  • Myocardial Blush at the start and end of the procedure [ Time Frame: pre PCI, directly post PCI ]
    Myocardial Blush at the start and end of the procedure
  • Maximum CK, and CK-MB levels [ Time Frame: upto 72 hours after randomisation ]
    Maximum CK, and CK-MB levels
  • Level of platelet inhibition at first medical contact, beginning and end of PCI procedure, as well as at 4 hours after prasugrel administration [ Time Frame: at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration ]
    Level of platelet inhibition at first medical contact, beginning and end of PCI procedure, as well as at 4 hours after prasugrel administration
  • Platelet reactivity, at each time point as well as over time [ Time Frame: at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration ]
    PRU measurements at first medical contact, beginning and end of PCI, as well as 4hours after drug administration
  • Rates of HPR [ Time Frame: upto 72 hours after randomisation ]
    Percentage of patients with PRU values over HPR threshold
  • Exploratory analyses within each group to evaluate any differences in PD among patients receiving morphine [ Time Frame: upto 72 hours after randomisation ]
    PD of each group among patients stratified for morphine treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CRUSHed vs. Uncrushed Prasugrel in STEMI Patients Undergoing PCI
Official Title  ICMJE COMPARison of Pre-hospital CRUSHed vs. Uncrushed Prasugrel Tablets in Patients With STEMI Undergoing Primary Percutaneous Coronary Interventions
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Crushed versus uncrushed tablets Prasugrel loading dose
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiovascular Diseases
Intervention  ICMJE
  • Drug: Prasugrel (Crushed tablets)
    loading dose of 6 crushed tablets 10mg Prasugrel
    Other Name: 6 Crushed tablets of Prasugrel 10mg
  • Drug: Prasugrel (Integral tablets)
    loading dose of 6 integral tablets of 10mg Prasugrel
    Other Name: 6 Integral tablets of Prasugrel 10mg
Study Arms  ICMJE
  • Active Comparator: Uncrushed
    6 Integral tablets Prasugrel as loading dose
    Intervention: Drug: Prasugrel (Integral tablets)
  • Experimental: Crushed
    6 Crushed tablets Prasugrel as loading dose
    Intervention: Drug: Prasugrel (Crushed tablets)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2020)
729
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2017)
674
Actual Study Completion Date  ICMJE May 1, 2021
Actual Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03296540
Other Study ID Numbers  ICMJE 2017-40
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maasstad Hospital
Study Sponsor  ICMJE Maasstad Hospital
Collaborators  ICMJE
  • MicroPort Orthopedics Inc.
  • Daiichi Sankyo, Inc.
  • Research Maatschap Cardiologen Rotterdam Zuid
Investigators  ICMJE
Principal Investigator: George Vlachojannis, MD, PhD Maasstadziekenhuis
Study Director: Pieter C Smits, MD, PhD Maasstadziekenhuis
Study Chair: Nicolas van Mieghem, MD, PhD Erasmus Medical Center
PRS Account Maasstad Hospital
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP