NCT05986968Active, not recruiting
Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 10 Jul 2023
- Start date
- 6 Jul 2023
- Primary completion date
- 3 Jan 2026
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT05986968
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 6 Jul 2023 to the primary completion date, 3 Jan 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous PCI or MI less than 12 months ago
- Previous cardiac surgery
- Concurrent use of oral anticoagulants (OAC)
- The periprocedural use of GPIIb/IIIa inhibitors
- Planned surgical intervention within 12 months of PCI
Other illness
- Known allergy or contraindication for aspirin, ticagrelor or prasugrel.
- PCI of stent thrombosis
Lab values
- 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))
- Creatinine clearance \<30mL/min or dialysis
Other
- Pregnancy and breast feeding
- 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).
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Noordwest Ziekenhuisgroep Alkmaar Coordinator of this site? Confirm its status | Alkmaar | Netherlands | Unknown status |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Rijnstate Coordinator of this site? Confirm its status | Arnhem | Netherlands | Unknown status |
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Unknown status |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.