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

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

Tracking Information

• First Submitted Date: July 10, 2023
• First Posted Date: August 14, 2023
• Last Update Posted Date: August 14, 2023
• Actual Study Start Date: July 6, 2023
• Estimated Primary Completion Date: July 6, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 3, 2023)

• 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
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 3, 2023)

• Bleeding complications [ Time Frame: 13 months ]
  Defined as Bleeding Academic Research Consortium (BARC) 2 or greater
• All-cause mortality [ Time Frame: 13 months ]
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: ST Elevation Myocardial Infarction

Intervention

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

Study Arms

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

  • Drug: Ticagrelor
  • Drug: Aspirin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 3, 2023): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 6, 2025
• Estimated Primary Completion Date: July 6, 2025 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT05986968
• Other Study ID Numbers: NL82646.091.22
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Radboud University Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Radboud University Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Radboud University Medical Center
• Verification Date: July 2023