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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005363-33 | EudraCT Number |
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| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
| Hospital San Carlos, Madrid | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| University Medical Center Nijmegen |
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The current trial will compare the protective effect of ticagrelor and prasugrel on microvascular dysfunction in patients with revascularized ST elevation myocardial infarction.
Coronary microvascular dysfunction is highly prevalent in revascularized ST-elevation myocardial infarction and has important prognostic implications. Current data suggest that ticagrelor might be superior to prasugrel in the reduction of coronary microvasculature dysfunction. Thus, we have designed a clinical trial that will compare microvascular function in revascularized ST-elevation myocardial infarction patients at treatment steady state with ticagrelor or prasugrel. Coronary microvascular dysfunction will be assessed with the index of microcirculatory resistance after primary percutaneous coronary intervention and at 1 month follow-up in the infarct-related vessel and non-infarct related vessel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental | Ticagrelor 90 mg twice a day, tablet Duration: 1 year after PCI |
|
| Prasugrel | Active Comparator | Prasugrel 10 mg once a day, tablet Duration: 1 year after PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | After a standard loading dose of 180 mg ticagrelor in the ambulance (before primary PCI), patients will receive a maintenance dose of ticagrelor 90 mg twice a day for 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Index of microcirculatory resistance (IMR) | measured in the infarct-related artery | 1 month after primary PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Delta Index of microcirculatory resistance (IMR) | measured in the infarct-related artery and non-infarct related artery | Baseline vs. 1 month follow-up |
| The reactive hyperemia index (RHI) | 1 month and 1 year after primary PCI |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU University Medical Center | Amsterdam | North Holland | 1081 HV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37204397 | Derived | Wang L, Travieso A, van der Hoeven N, van Leeuwen MAH, Janssens G, Mejia-Renteria H, Jeronimo A, Gonzalo N, Nijveldt R, van Royen N, Escaned J. Improved Nonculprit Stenosis Assessment in Patients With ST-Segment Elevation Myocardial Infarction Using Quantitative Flow Ratio. JACC Cardiovasc Interv. 2023 Jul 24;16(14):1828-1830. doi: 10.1016/j.jcin.2023.04.045. Epub 2023 May 19. No abstract available. | |
| 32122216 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| OTHER |
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|
| Prasugrel | Drug | After a standard loading dose of 180 mg ticagrelor in the ambulance (before primary PCI), patients will receive a single loading dose of prasugrel 60 mg (1 day after standard loading dose ticagrelor),followed by a maintenance dose of prasugrel 10 mg once a day for 1 year. |
|
|
| Myocardial salvage | measured with MRI | 1 month after primary PCI |
| Left ventricular ejection fraction (LVEF) recovery | measured with MRI | 1 month after primary PCI |
| Microvascular obstruction | measured with MRI | 3 days after primary PCI |
| Asymmetric Dimethylarginine (ADMA) levels | Blood measurements | 1 month after primary PCI |
| Intra-myocardial haemorrhage | measured with MRI | 3 days after primary PCI |
| Derived |
| van der Hoeven NW, Janssens GN, Everaars H, Nap A, Lemkes JS, de Waard GA, van de Ven PM, van Rossum AC, Escaned J, Mejia-Renteria H, Ten Cate TJF, Piek JJ, von Birgelen C, Valgimigli M, Diletti R, Riksen NP, Van Mieghem NM, Nijveldt R, van Leeuwen MAH, van Royen N. Platelet Inhibition, Endothelial Function, and Clinical Outcome in Patients Presenting With ST-Segment-Elevation Myocardial Infarction Randomized to Ticagrelor Versus Prasugrel Maintenance Therapy: Long-Term Follow-Up of the REDUCE-MVI Trial. J Am Heart Assoc. 2020 Mar 3;9(5):e014411. doi: 10.1161/JAHA.119.014411. Epub 2020 Mar 3. |
| 30586720 | Derived | van Leeuwen MAH, van der Hoeven NW, Janssens GN, Everaars H, Nap A, Lemkes JS, de Waard GA, van de Ven PM, van Rossum AC, Ten Cate TJF, Piek JJ, von Birgelen C, Escaned J, Valgimigli M, Diletti R, Riksen NP, van Mieghem NM, Nijveldt R, van Royen N. Evaluation of Microvascular Injury in Revascularized Patients With ST-Segment-Elevation Myocardial Infarction Treated With Ticagrelor Versus Prasugrel. Circulation. 2019 Jan 29;139(5):636-646. doi: 10.1161/CIRCULATIONAHA.118.035931. |
| 27102290 | Derived | Janssens GN, van Leeuwen MAH, van der Hoeven NW, de Waard GA, Nijveldt R, Diletti R, Zijlstra F, von Birgelen C, Escaned J, Valgimigli M, van Royen N. Reducing Microvascular Dysfunction in Revascularized Patients with ST-Elevation Myocardial Infarction by Off-Target Properties of Ticagrelor versus Prasugrel. Rationale and Design of the REDUCE-MVI Study. J Cardiovasc Transl Res. 2016 Jun;9(3):249-256. doi: 10.1007/s12265-016-9691-3. Epub 2016 Apr 21. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |