CRUSHed vs. Uncrushed Prasugrel in STEMI Patients Undergoing PCI

COMPARison of Pre-hospital CRUSHed vs. Uncrushed Prasugrel Tablets in Patients With STEMI Undergoing Primary Percutaneous Coronary Interventions

Sponsors

Lead Sponsor: Maasstad Hospital

Collaborator: MicroPort Orthopedics Inc.
Daiichi Sankyo, Inc.
Research Maatschap Cardiologen Rotterdam Zuid

Source 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.

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

Overall Status Completed
Start Date 2017-11-28
Completion Date 2021-05-01
Primary Completion Date 2021-05-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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 directly post PCI
Secondary Outcome
Measure Time Frame
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
Corrected TIMI frame count (cTFC) at angiography, pre and post PCI. pre PCI, directly post PCI
TIMI myocardial perfusion grade (TMPG) at angiography, pre and post PCI. pre PCI, directly post PCI
Time-relationship (from symptom onset to 1st dose intake) on each co-primary directly post-PCI
Time-relationship (from 1st dose intake to ECG/ angiography) on each co-primary directly post-PCI
TIMI flow grade 3 at end of procedure. directly post PCI
Myocardial Blush at the start and end of the procedure pre PCI, directly post PCI
Maximum CK, and CK-MB levels upto 72 hours after randomisation
Level of platelet inhibition at first medical contact, beginning and end of PCI procedure, as well as at 4 hours after prasugrel administration at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration
Platelet reactivity, at each time point as well as over time at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration
Rates of HPR upto 72 hours after randomisation
Exploratory analyses within each group to evaluate any differences in PD among patients receiving morphine upto 72 hours after randomisation
Enrollment 729
Condition
Intervention

Intervention Type: Drug

Intervention Name: Prasugrel (Crushed tablets)

Description: loading dose of 6 crushed tablets 10mg Prasugrel

Arm Group Label: Crushed

Other Name: 6 Crushed tablets of Prasugrel 10mg

Intervention Type: Drug

Intervention Name: Prasugrel (Integral tablets)

Description: loading dose of 6 integral tablets of 10mg Prasugrel

Arm Group Label: Uncrushed

Other Name: 6 Integral tablets of Prasugrel 10mg

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Location
Facility:
Erasmus Medical Center | Rotterdam, 3015 CE, Netherlands
Maasstadziekenhuis | Rotterdam, 3079 DZ, Netherlands
Location Countries

Netherlands

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Uncrushed

Type: Active Comparator

Description: 6 Integral tablets Prasugrel as loading dose

Label: Crushed

Type: Experimental

Description: 6 Crushed tablets Prasugrel as loading dose

Acronym CompareCrush
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Crushed versus uncrushed tablets Prasugrel loading dose

Primary Purpose: Treatment

Masking: None (Open Label)

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