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

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ClinicalTrials.gov Identifier: NCT03296540
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : February 28, 2018
Sponsor:
Collaborators:
MicroPort Orthopedics Inc.
Daiichi Sankyo, Inc.
Research Maatschap Cardiologen Rotterdam Zuid
Information provided by (Responsible Party):
Maasstad Hospital

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: Prasugrel (Crushed tablets) Drug: Prasugrel (Integral tablets) Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 674 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Crushed versus uncrushed tablets Prasugrel loading dose
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COMPARison of Pre-hospital CRUSHed vs. Uncrushed Prasugrel Tablets in Patients With STEMI Undergoing Primary Percutaneous Coronary Interventions
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Prasugrel

Arm Intervention/treatment
Active Comparator: Uncrushed
6 Integral tablets Prasugrel as loading dose
Drug: Prasugrel (Integral tablets)
loading dose of 6 integral tablets of 10mg Prasugrel
Other Name: 6 Integral tablets of Prasugrel 10mg

Experimental: Crushed
6 Crushed tablets Prasugrel as loading dose
Drug: Prasugrel (Crushed tablets)
loading dose of 6 crushed tablets 10mg Prasugrel
Other Name: 6 Crushed tablets of Prasugrel 10mg




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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

  10. TIMI flow grade 3 at end of procedure. [ Time Frame: directly post PCI ]
    TIMI flow grade 3 at end of procedure.

  11. 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

  12. Maximum CK, and CK-MB levels [ Time Frame: upto 72 hours after randomisation ]
    Maximum CK, and CK-MB levels

  13. 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

  14. 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

  15. Rates of HPR [ Time Frame: upto 72 hours after randomisation ]
    Percentage of patients with PRU values over HPR threshold

  16. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296540


Contacts
Contact: Ria van Vliet +31644162844 VlietM@maastadziekenhuis.nl
Contact: George Vlachojannis, MD, PhD +31685271550 VlachojannisG@maasstadziekenhuis.nl

Locations
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Roberto Diletti, MD, PhD       r.diletti@erasmusmc.nl   
Maasstadziekenhuis Recruiting
Rotterdam, Netherlands, 3079 DZ
Contact: George Vlachojannis, MD, PhD    +31685271550    VlachojannisG@maasstadziekenhuis.nl   
Sponsors and Collaborators
Maasstad Hospital
MicroPort Orthopedics Inc.
Daiichi Sankyo, Inc.
Research Maatschap Cardiologen Rotterdam Zuid
Investigators
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

Responsible Party: Maasstad Hospital
ClinicalTrials.gov Identifier: NCT03296540     History of Changes
Other Study ID Numbers: 2017-40
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maasstad Hospital:
STEMI

Additional relevant MeSH terms:
Cardiovascular Diseases
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors