Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The main goal of this clinical trial is to assess whether direct omission of aspirin after Percutaneous Coronary Intervention (PCI) with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in patients with ST elevation myocardial infarction (STEMI). Furthermore, the two treatment strategies will be compared regarding the incidence and extent of intramyocardial haemorrhage (IMH) and infarct size in the first week after PCI as determined with Cardiac Magnetic Resonance (CMR). The secondary efficacy endpoint consists of clinical bleeding events and all-cause mortality. The main analyses will comprise of clinical outcomes in the first three months after primary PCI and of CMR results. In addition, we will report on clinical outcomes at thirteen months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Clinical and electrocardiographical diagnosis of STEMI

• Successful PCI (according to the treating physician) of the infarct-related vessel with a modern drug-eluting stent (DES)

Locations
Other Locations
Netherlands
Noordwest Ziekenhuisgroep Alkmaar
RECRUITING
Alkmaar
Amsterdam UMC
RECRUITING
Amsterdam
Rijnstate
RECRUITING
Arnhem
Medisch Spectrum Twente
RECRUITING
Enschede
Radboudumc
RECRUITING
Nijmegen
Contact Information
Primary
Peter Damman, MD, PhD, FESC
peter.damman@radboudumc.nl
0031243616785
Time Frame
Start Date: 2023-07-06
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 200
Treatments
Experimental: Treatment arm
Ticagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor)
Active_comparator: Control arm
Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months.
Sponsors
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov