COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions

Completed

• Conditions: STEMI; ST elevation myocardial infarction; 10011082

• Registration Number: NL-OMON50482
• Lead Sponsor: Research Maatschap Cardiologen Rotterdam Zuid

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-05-15
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 729

Inclusion Criteria

- Consecutive patients with STEMI planned for primary PCI
- Deferred written informed consent within 4 hours after initial treatment
- 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. However, patients on
maintenance dose clopidogrel for at least 7 days are included in the study. See
appendix A (patient on clopidogrel maintenance dose)
- 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 or 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the efficacy of crushed vs. integral tablets of prasugrel loading<br /><br>dose treatment by comparing the percentage of STEMI patients reaching the<br /><br>independent co-primary endpoint of TIMI flow grade 3 of MI culprit vessel at<br /><br>initial angiography or a >=70% ST-segment elevation resolution 60min post-PCI. </p><br>