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
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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 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 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment arm
Ticagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor)
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Drug: Ticagrelor
Ticagrelor monotherapy for 12 months |
Active Comparator: Control arm
Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months.
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Drug: Ticagrelor
Ticagrelor monotherapy for 12 months Drug: Aspirin Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months |
- 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.
- 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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).
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
Contact: Peter Damman, MD, PhD, FESC | 0031243616785 | peter.damman@radboudumc.nl |
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 |
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 |
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 |
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 |