Assessing Ticagrelor Alone After Heart Attack Treatment
Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage
This study is testing if taking ticagrelor alone for a year after a heart attack is safe and effective compared to taking it with aspirin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 5 sites (Alkmaar and 4 other locations) |
| Trial ID | NCT05986968 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety of using ticagrelor alone for 12 months after a primary Percutaneous Coronary Intervention (PCI) in patients with ST elevation myocardial infarction (STEMI), compared to a combination of ticagrelor and aspirin. The study will monitor the incidence of ischemic events and the extent of intramyocardial hemorrhage (IMH) using Cardiac Magnetic Resonance imaging in the first week post-PCI. Additionally, clinical outcomes such as bleeding events and all-cause mortality will be assessed over a period of thirteen months. The primary focus is on the first three months following the intervention.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with STEMI who have successfully undergone PCI with a drug-eluting stent.
Not a fit: Patients with known allergies to the study medications, recent cardiac events, or those requiring concurrent anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer alternative treatment regimen for patients recovering from STEMI.
How similar studies have performed: Other studies have explored similar antiplatelet strategies, but this specific approach of omitting aspirin post-PCI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Known allergy or contraindication for aspirin, ticagrelor or prasugrel. * Previous PCI or MI less than 12 months ago * Previous cardiac surgery * Participation in another clinical cardiology study or study concerning platelet aggregation/ thrombosis. (unless the antithrombotic therapy prescribed in this other study will end due to clinical reasons (e.g. the STEMI)) * Pregnancy and breast feeding * Concurrent use of oral anticoagulants (OAC) * The periprocedural use of GPIIb/IIIa inhibitors * Planned surgical intervention within 12 months of PCI * Creatinine clearance \<30mL/min or dialysis * PCI of stent thrombosis * Suboptimal stent result as judged by the interventional cardiologist. * Life expectancy shorter than 13 months. * Contra-indications for MRI or unable to undergo MRI (only applicable for the CMR subgroup population).
Where this trial is running
Alkmaar and 4 other locations
- Noordwest Ziekenhuisgroep Alkmaar — Alkmaar, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Rijnstate — Arnhem, Netherlands (Recruiting)
- Medisch Spectrum Twente — Enschede, Netherlands (Recruiting)
- Radboudumc — Nijmegen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Peter Damman, MD, PhD, FESC
- Email: peter.damman@radboudumc.nl
- Phone: 0031243616785
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.