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Reducing Micro Vascular Dysfunction in Acute Myocardial Infarction by Ticagrelor (REDUCE-MVI)

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Ticagrelor
Prasugrel
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring ST elevation myocardial infarction, Percutaneous coronary intervention, Endothelial function, Ticagrelor, Prasugrel

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision of informed consent
  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:

  1. history of myocardial infarction
  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

Sites / Locations

  • VU University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor

Prasugrel

Arm Description

Ticagrelor 90 mg twice a day, tablet Duration: 1 year after PCI

Prasugrel 10 mg once a day, tablet Duration: 1 year after PCI

Outcomes

Primary Outcome Measures

Index of microcirculatory resistance (IMR)
measured in the infarct-related artery

Secondary Outcome Measures

Delta Index of microcirculatory resistance (IMR)
measured in the infarct-related artery and non-infarct related artery
The reactive hyperemia index (RHI)
Myocardial salvage
measured with MRI
Left ventricular ejection fraction (LVEF) recovery
measured with MRI
Microvascular obstruction
measured with MRI
Asymmetric Dimethylarginine (ADMA) levels
Blood measurements
Intra-myocardial haemorrhage
measured with MRI

Full Information

First Posted
April 13, 2015
Last Updated
April 30, 2018
Sponsor
Amsterdam UMC, location VUmc
Collaborators
Erasmus Medical Center, Hospital San Carlos, Madrid, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University Medical Center Nijmegen
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1. Study Identification

Unique Protocol Identification Number
NCT02422888
Brief Title
Reducing Micro Vascular Dysfunction in Acute Myocardial Infarction by Ticagrelor
Acronym
REDUCE-MVI
Official Title
Reducing Micro Vascular Dysfunction In Revascularized ST-elevation Myocardial Infarction Patients by Off-target Properties of Ticagrelor
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
Erasmus Medical Center, Hospital San Carlos, Madrid, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University Medical Center Nijmegen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The current trial will compare the protective effect of ticagrelor and prasugrel on microvascular dysfunction in patients with revascularized ST elevation myocardial infarction.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
ST elevation myocardial infarction, Percutaneous coronary intervention, Endothelial function, Ticagrelor, Prasugrel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
Ticagrelor 90 mg twice a day, tablet Duration: 1 year after PCI
Arm Title
Prasugrel
Arm Type
Active Comparator
Arm Description
Prasugrel 10 mg once a day, tablet Duration: 1 year after PCI
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brilique
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Other Intervention Name(s)
Efient
Intervention Description
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.
Primary Outcome Measure Information:
Title
Index of microcirculatory resistance (IMR)
Description
measured in the infarct-related artery
Time Frame
1 month after primary PCI
Secondary Outcome Measure Information:
Title
Delta Index of microcirculatory resistance (IMR)
Description
measured in the infarct-related artery and non-infarct related artery
Time Frame
Baseline vs. 1 month follow-up
Title
The reactive hyperemia index (RHI)
Time Frame
1 month and 1 year after primary PCI
Title
Myocardial salvage
Description
measured with MRI
Time Frame
1 month after primary PCI
Title
Left ventricular ejection fraction (LVEF) recovery
Description
measured with MRI
Time Frame
1 month after primary PCI
Title
Microvascular obstruction
Description
measured with MRI
Time Frame
3 days after primary PCI
Title
Asymmetric Dimethylarginine (ADMA) levels
Description
Blood measurements
Time Frame
1 month after primary PCI
Title
Intra-myocardial haemorrhage
Description
measured with MRI
Time Frame
3 days after primary PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of informed consent Patients presenting with ST-elevation myocardial infarction <12 hours after symptom onset Successful percutaneous coronary intervention of the infarct-related vessel with a modern drug-eluting stent Intermediate stenosis in non-infarct-related vessel (50-90%) Exclusion Criteria: history of myocardial infarction Participation in another clinical study with an investigational product during the preceding 30 days history of cerebrovascular accident (CVA) or 'transient ischaemic attack' (TIA) History of intracranial haemorrhage indication or use of oral anticoagulant therapy (i.e. acenocoumarol) severe liver dysfunction (Child-Pugh score 10-15) congestive heart failure cardiogenic shock left ventricular ejection fraction < 35% bleeding diathesis age ≥ 75 or < 18 body weight < 60 kg gout coagulation disorders severe pulmonary disease pregnancy and breast feeding limited life expectancy platelet count < 100 000/mm3 history of drug addiction or alcohol abuse in the past 2 years need for chronic nonsteroidal anti-inflammatory drug creatinine clearance <30 mL/min or dialysis chronic total occlusion (CTO) Left main disease allergy or contra-indication for ticagrelor or prasugrel Contra-indication for adenosine Patients unable to be followed on-site Unable to undergo or contra-indications for MRI Contra-indication for drug-eluting stent Inability to obtain informed consent Coronary artery bypass grafting in medical history
Facility Information:
Facility Name
VU University Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
32122216
Citation
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.
Results Reference
derived
PubMed Identifier
30586720
Citation
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.
Results Reference
derived
PubMed Identifier
27102290
Citation
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.
Results Reference
derived

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Reducing Micro Vascular Dysfunction in Acute Myocardial Infarction by Ticagrelor

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