Reducing Micro Vascular Dysfunction in Acute Myocardial Infarction by Ticagrelor
NCT ID: NCT02422888
Last Updated: 2018-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
110 participants
INTERVENTIONAL
2015-05-31
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ticagrelor
Ticagrelor 90 mg twice a day, tablet Duration: 1 year after PCI
Ticagrelor
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.
Prasugrel
Prasugrel 10 mg once a day, tablet Duration: 1 year after PCI
Prasugrel
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.
Interventions
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Ticagrelor
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.
Prasugrel
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients presenting with ST-elevation myocardial infarction \<12 hours after symptom onset
3. Successful percutaneous coronary intervention of the infarct-related vessel with a modern drug-eluting stent
4. Intermediate stenosis in non-infarct-related vessel (50-90%)
Exclusion Criteria
2. Participation in another clinical study with an investigational product during the preceding 30 days
3. history of cerebrovascular accident (CVA) or 'transient ischaemic attack' (TIA)
4. History of intracranial haemorrhage
5. indication or use of oral anticoagulant therapy (i.e. acenocoumarol)
6. severe liver dysfunction (Child-Pugh score 10-15)
7. congestive heart failure
8. cardiogenic shock
9. left ventricular ejection fraction \< 35%
10. bleeding diathesis
11. age ≥ 75 or \< 18
12. body weight \< 60 kg
13. gout
14. coagulation disorders
15. severe pulmonary disease
16. pregnancy and breast feeding
17. limited life expectancy
18. platelet count \< 100 000/mm3
19. history of drug addiction or alcohol abuse in the past 2 years
20. need for chronic nonsteroidal anti-inflammatory drug
21. creatinine clearance \<30 mL/min or dialysis
22. chronic total occlusion (CTO)
23. Left main disease
24. allergy or contra-indication for ticagrelor or prasugrel
25. Contra-indication for adenosine
26. Patients unable to be followed on-site
27. Unable to undergo or contra-indications for MRI
28. Contra-indication for drug-eluting stent
29. Inability to obtain informed consent
30. Coronary artery bypass grafting in medical history
18 Years
74 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Hospital San Carlos, Madrid
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
University Medical Center Nijmegen
OTHER
Amsterdam UMC, location VUmc
OTHER
Responsible Party
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Maarten van Leeuwen
Study coordinator
Locations
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VU University Medical Center
Amsterdam, North Holland, Netherlands
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2014-005363-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ESR-14-10048
Identifier Type: -
Identifier Source: org_study_id
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