COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with acute heart infarct undergoing dotter treatment.

Phase 1

• Conditions: ST elevated Myocardial infarction (STEMI); MedDRA version: 20.0Level: LLTClassification code 10064346Term: STEMISystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002419-32-NL
• Lead Sponsor: Research Maatschap Cardiologen Rijnmond Zuid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-29
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 674

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 374

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. Patients on maintenance dose clopidogrel for at least 7 days are included.
- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified