NCT03296540

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 729 (actual)
• Sponsor: Maasstad Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	Prasugrel (Crushed tablets)	loading dose of 6 crushed tablets 10mg Prasugrel
DRUG	Prasugrel (Integral tablets)	loading dose of 6 integral tablets of 10mg Prasugrel

Timeline

• Start date: 2017-11-28
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2017-09-28
• Last updated: 2021-05-07

Locations

2 sites across 1 country: Netherlands