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

Overview

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.

Interventions

• Drug Ticagrelor
  Ticagrelor monotherapy for 12 months
• Drug Aspirin
  Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months

Primary outcome measures

• Composite of major adverse cardiac and cerebral events (MACCE) [Time frame: 1, 3 and 13 months after primary PCI]
• Intramyocardial haemorrhage (IMH) [Time frame: day 5-8 post primary PCI]

Secondary outcome measures (3)

• Bleeding complications [Time frame: 1, 3 and 13 months after primary PCI]
• All-cause mortality [Time frame: 1, 3 and 13 months after primary PCI]
• Platelet reactivity [Time frame: 5-8 days]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Netherlands · 5 centers

• Noordwest Ziekenhuisgroep Alkmaar — Alkmaar
• Amsterdam UMC — Amsterdam
• Rijnstate — Arnhem
• Medisch Spectrum Twente — Enschede
• Radboudumc — Nijmegen

Publications

• Yosofi B, Woelders ECI, Peeters DAM, von Birgelen C, van Rees JB, Heestermans AACM, Claessen BEPM, van den Oord SCH, Dirksen MT, van Vliet D, Konijnenberg LSF, Cetinyurek-Yavuz A, van Royen N, van Geuns RM, Nijveldt R, Damman P. Ticagrelor monotherapy versus dual antiplatelet therapy after primary percutaneous coronary intervention: one-year outcomes of the pilot STOP-IMH randomised trial. EuroInt PMID 42200636

Identifiers

NCT: NCT05986968 · NL82646.091.22

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗