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

NCT05986968 | Recruiting DMC

• 1 other identifier: NL82646.091.22
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

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) 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.

Conditions

ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• Composite of major adverse cardiac and cerebral events (MACCE)

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

  1, 3 and 13 months after primary PCI

• Intramyocardial haemorrhage (IMH)

  Size of IMH and infarct determined by Cardiac Magnetic Resonance imaging at day 5-8 post primary PCI.

  day 5-8 post primary PCI

Secondary Outcomes (3)

• Bleeding complications

  1, 3 and 13 months after primary PCI

• All-cause mortality

  1, 3 and 13 months after primary PCI

• Platelet reactivity

  5-8 days

Study Arms (2)

Treatment arm

EXPERIMENTAL

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

Drug: Ticagrelor

Control arm

ACTIVE COMPARATOR

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

Drug: Ticagrelor; Drug: Aspirin

Interventions

Ticagrelor DRUG

Ticagrelor monotherapy for 12 months

Control arm; Treatment arm

Aspirin DRUG

Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (5)

Noordwest Ziekenhuisgroep Alkmaar

Alkmaar, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Rijnstate

Arnhem, Netherlands

RECRUITING

Medisch Spectrum Twente

Enschede, Netherlands

RECRUITING

Radboudumc

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Ticagrelor; Aspirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Peter Damman, MD, PhD, FESC

CONTACT

0031243616785; peter.damman@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 14, 2023
• Study Start: July 6, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (5)