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

Not Applicable

Recruiting

• Conditions: ST Elevation Myocardial Infarction
• Interventions: Drug: Ticagrelor; Drug: Aspirin

• Registration Number: NCT05986968
• Lead Sponsor: Radboud University Medical Center

Brief 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) in the first week after PCI. The secondary efficacy endpoint consists of clinical bleeding events and all-cause mortality.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-06
• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Aspirin	Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months.
Control arm	Ticagrelor	Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months.
Treatment arm	Ticagrelor	Ticagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor)

Primary Outcome Measures

Name	Time	Method
Composite of major adverse cardiac and cerebral events (MACCE)	1, 3 and 13 months after primary PCI	Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality
Intramyocardial haemorrhage (IMH)	day 5-8 post primary PCI	Size of IMH and infarct determined by Cardiac Magnetic Resonance imaging at day 5-8 post primary PCI.

Secondary Outcome Measures

Name	Time	Method
Bleeding complications	1, 3 and 13 months after primary PCI	Defined as Bleeding Academic Research Consortium (BARC) 2 or greater
All-cause mortality	1, 3 and 13 months after primary PCI
Platelet reactivity	5-8 days	Differences in platelet reactivity between ticagrelor monotherapy and ticagrelor + aspirin will be measured as Aspirin Reaction Units (ARU) using the VerifyNow test.

Trial Locations

Locations (5)

Noordwest Ziekenhuisgroep Alkmaar; 🇳🇱 Alkmaar, Netherlands

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

Radboudumc; 🇳🇱 Nijmegen, Netherlands

Rijnstate; 🇳🇱 Arnhem, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands