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NCT Number: NCT05986968

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

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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Key information

Conditions

ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Noordwest Ziekenhuisgroep Alkmaar, Alkmaar, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ticagrelor

Drug

Ticagrelor monotherapy for 12 months

Aspirin

Drug

Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months

Primary outcomes

  1. Composite of major adverse cardiac and cerebral events (MACCE)

    Time frame: 1, 3 and 13 months after primary PCI

    Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality

  2. Intramyocardial haemorrhage (IMH)

    Time frame: 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 outcomes

  1. Bleeding complications

    Time frame: 1, 3 and 13 months after primary PCI

    Defined as Bleeding Academic Research Consortium (BARC) 2 or greater

  2. All-cause mortality

    Time frame: 1, 3 and 13 months after primary PCI

  3. Platelet reactivity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Damman, MD, PhD, FESC

CONTACT

[email protected]

0031243616785

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: STOP-IMH

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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