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

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ClinicalTrials.gov Identifier: NCT05986968
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
Radboud University Medical Center

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 6, 2023
Estimated Primary Completion Date : July 6, 2025
Estimated Study Completion Date : July 6, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Composite of major adverse cardiac and cerebral events (MACCE) [ Time Frame: 13 months ]
    Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality

  2. Intramyocardial haemorrhage (IMH) [ Time Frame: 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 :
  1. Bleeding complications [ Time Frame: 13 months ]
    Defined as Bleeding Academic Research Consortium (BARC) 2 or greater

  2. All-cause mortality [ Time Frame: 13 months ]
  3. Platelet reactivity of aspirin measured as Aspirin Reaction Units (ARU) using the VerifyNow test [ Time Frame: 5-8 days ]
    Differences in platelet reactivity between ticagrelor monotherapy and ticagrelor + aspirin will be measured


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05986968


Contacts
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Contact: Peter Damman, MD, PhD, FESC 0031243616785 peter.damman@radboudumc.nl

Locations
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Netherlands
Noordwest Ziekenhuisgroep Alkmaar Not yet recruiting
Alkmaar, Netherlands
Contact: Maurits Dirksen, MD, PhD         
Amsterdam UMC Not yet recruiting
Amsterdam, Netherlands
Contact: Bimmer Claessen, MD, PhD         
Medisch Spectrum Twente Not yet recruiting
Enschede, Netherlands
Contact: Clemens Von Birgelen, MD, Prof         
Medisch Centrum Leeuwarden Not yet recruiting
Leeuwarden, Netherlands
Contact: Pier Woudstra, MD, PhD         
Radboudumc Recruiting
Nijmegen, Netherlands
Contact: Peter Damman, MD, PhD, FESC         
Sponsors and Collaborators
Radboud University Medical Center
More Information
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT05986968    
Other Study ID Numbers: NL82646.091.22
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Hemorrhage
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aspirin
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists