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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05986968

Collaborator

(none)

200

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
ST Elevation Myocardial Infarction	Drug: Ticagrelor Drug: Aspirin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 6, 2023

Anticipated Primary Completion Date :

Jul 6, 2025

Anticipated Study Completion Date :

Jul 6, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment arm Ticagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor)	Drug: Ticagrelor Ticagrelor monotherapy for 12 months
Active Comparator: Control arm Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months.	Drug: Ticagrelor Ticagrelor monotherapy for 12 months Drug: Aspirin Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months

Arm

Intervention/Treatment

Experimental: Treatment arm

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

Drug: Ticagrelor

Ticagrelor monotherapy for 12 months

Active Comparator: Control arm

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

Drug: Ticagrelor

Ticagrelor monotherapy for 12 months

Drug: Aspirin

Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Bleeding complications [13 months]
Defined as Bleeding Academic Research Consortium (BARC) 2 or greater
All-cause mortality [13 months]
Platelet reactivity of aspirin measured as Aspirin Reaction Units (ARU) using the VerifyNow test [5-8 days]
Differences in platelet reactivity between ticagrelor monotherapy and ticagrelor + aspirin will be measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	Country
1	Noordwest Ziekenhuisgroep Alkmaar	Alkmaar	Netherlands
2	Amsterdam UMC	Amsterdam	Netherlands
3	Medisch Spectrum Twente	Enschede	Netherlands
4	Medisch Centrum Leeuwarden	Leeuwarden	Netherlands
5	Radboudumc	Nijmegen	Netherlands