CRUSHed vs. Uncrushed Prasugrel in STEMI Patients Undergoing PCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

729 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2021-05-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Crushed versus uncrushed tablets Prasugrel loading dose

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Uncrushed

6 Integral tablets Prasugrel as loading dose

Group Type ACTIVE_COMPARATOR

Prasugrel (Integral tablets)

Intervention Type DRUG

loading dose of 6 integral tablets of 10mg Prasugrel

Crushed

6 Crushed tablets Prasugrel as loading dose

Group Type EXPERIMENTAL

Prasugrel (Crushed tablets)

Intervention Type DRUG

loading dose of 6 crushed tablets 10mg Prasugrel

Interventions

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Prasugrel (Crushed tablets)

loading dose of 6 crushed tablets 10mg Prasugrel

Intervention Type DRUG

Prasugrel (Integral tablets)

loading dose of 6 integral tablets of 10mg Prasugrel

Intervention Type DRUG

Other Intervention Names

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6 Crushed tablets of Prasugrel 10mg 6 Integral tablets of Prasugrel 10mg

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No