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

ST Elevation Myocardial Infarction Clinical Trial

— STOP-IMH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986968
• Other study ID #: NL82646.091.22
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2023
• Est. completion date: July 6, 2025

Study information

• Verified date: July 2023
• Source: Radboud University Medical Center
• Contact: Peter Damman, MD, PhD, FESC
• Phone: 0031243616785
• Email: peter.damman[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main goal of this clinical trial is to assess the safety of direct omission of aspirin after Percutaneous Coronary Intervention (PCI) in patients with ST elevation myocardial infarction (STEMI). The secondary objectives are to demonstrate the reduction of intramyocardial haemorrhage and infarct size, which will be measured after 1 week; to compare clinical bleeding outcomes and to compare platelet reactivity and inflammatory response in STEMI patients receiving ticagrelor monotherapy versus dual antiplatelet therapy. Patients will be treated with either ticagrelor monotherapy or dual antiplatelet therapy (aspirin plus ticagrelor) after PCI. They will be compared to see if the omission of aspirin is safe in terms of major adverse cardiac and cerebral events at 13 months follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 6, 2025
• Est. primary completion date: July 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical and electrocardiographical diagnosis of STEMI
• Successful PCI (according to the treating physician) of the infarct-related vessel with a modern 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.
• 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.
• Contra-indications for MRI or unable to undergo MRI (only applicable for the CMR subgroup population).

Related Conditions & MeSH terms

• Hemorrhage
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Netherlands	Noordwest Ziekenhuisgroep Alkmaar	Alkmaar
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	Radboudumc	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of major adverse cardiac and cerebral events (MACCE)	Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality	13 months
Primary	Intramyocardial haemorrhage (IMH)	Size of IMH and infarct determined by Cardiac Magnetic Resonance imaging at day 5-8 post-PCI.	day 5-8 post PCI
Secondary	Bleeding complications	Defined as Bleeding Academic Research Consortium (BARC) 2 or greater	13 months
Secondary	All-cause mortality		13 months
Secondary	Platelet reactivity of aspirin measured as Aspirin Reaction Units (ARU) using the VerifyNow test	Differences in platelet reactivity between ticagrelor monotherapy and ticagrelor + aspirin will be measured	5-8 days