NCT03296540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
729

participants targeted

Target at P75+ for phase_4 cardiovascular-diseases

Timeline
Completed

Started Nov 2017

Typical duration for phase_4 cardiovascular-diseases

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 28, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

3.4 years

First QC Date

September 6, 2017

Last Update Submit

May 6, 2021

Conditions

Cardiovascular Diseases

Keywords

STEMI

Outcome Measures

Primary Outcomes (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

    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.

    directly post PCI

Secondary Outcomes (16)

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

    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

    30 days and 12 months

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

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

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

    directly post PCI

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

    pre-PCI and 60 min post-PCI

  • +11 more secondary outcomes

Study Arms (2)

Uncrushed

ACTIVE COMPARATOR

6 Integral tablets Prasugrel as loading dose

Drug: Prasugrel (Integral tablets)

Crushed

EXPERIMENTAL

6 Crushed tablets Prasugrel as loading dose

Drug: Prasugrel (Crushed tablets)

Interventions

Prasugrel (Crushed tablets)DRUG

loading dose of 6 crushed tablets 10mg Prasugrel

Also known as: 6 Crushed tablets of Prasugrel 10mg
Crushed
Prasugrel (Integral tablets)DRUG

loading dose of 6 integral tablets of 10mg Prasugrel

Also known as: 6 Integral tablets of Prasugrel 10mg
Uncrushed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Erasmus Medical Center

Rotterdam, 3015 CE, Netherlands

Location

Maasstadziekenhuis

Rotterdam, 3079 DZ, Netherlands

Location

Related Publications (2)

  • Vlachojannis GJ, Wilschut JM, Vogel RF, Lemmert ME, Delewi R, Diletti R, van der Waarden NWPL, Nuis RJ, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Van Mieghem NM, Smits PC. Effect of Prehospital Crushed Prasugrel Tablets in Patients With ST-Segment-Elevation Myocardial Infarction Planned for Primary Percutaneous Coronary Intervention: The Randomized COMPARE CRUSH Trial. Circulation. 2020 Dec 15;142(24):2316-2328. doi: 10.1161/CIRCULATIONAHA.120.051532. Epub 2020 Oct 14.

    PMID: 33315489DERIVED

  • Vlachojannis GJ, Vogel RF, Wilschut JM, Lemmert ME, Delewi R, Diletti R, van Vliet R, van der Waarden N, Nuis RJ, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Van Mieghem NM, Smits PC. COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial. Am Heart J. 2020 Jun;224:10-16. doi: 10.1016/j.ahj.2020.03.005. Epub 2020 Mar 11.

    PMID: 32272255DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesST Elevation Myocardial Infarction

Interventions

Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • George Vlachojannis, MD, PhD

    Maasstadziekenhuis

    PRINCIPAL INVESTIGATOR

  • Pieter C Smits, MD, PhD

    Maasstadziekenhuis

    STUDY DIRECTOR

  • Nicolas van Mieghem, MD, PhD

    Erasmus Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Crushed versus uncrushed tablets Prasugrel loading dose
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 28, 2017

Study Start

November 28, 2017

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

May 7, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)