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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-06

Study Completion Date

2025-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm

Ticagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor)

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Ticagrelor monotherapy for 12 months

Control arm

Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months.

Group Type ACTIVE_COMPARATOR

Ticagrelor

Intervention Type DRUG

Ticagrelor monotherapy for 12 months

Aspirin

Intervention Type DRUG

Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months

Interventions

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Ticagrelor

Ticagrelor monotherapy for 12 months

Intervention Type DRUG

Aspirin

Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No