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

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ClinicalTrials.gov Identifier: NCT02422888
Recruitment Status : Unknown
Verified April 2018 by Maarten van Leeuwen, VU University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : April 21, 2015
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
Erasmus Medical Center
Hospital San Carlos, Madrid
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Medical Center Nijmegen
Information provided by (Responsible Party):
Maarten van Leeuwen, VU University Medical Center

Tracking Information
First Submitted Date  ICMJE April 13, 2015
First Posted Date  ICMJE April 21, 2015
Last Update Posted Date May 3, 2018
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2015)
Index of microcirculatory resistance (IMR) [ Time Frame: 1 month after primary PCI ]
measured in the infarct-related artery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2015)
  • Delta Index of microcirculatory resistance (IMR) [ Time Frame: Baseline vs. 1 month follow-up ]
    measured in the infarct-related artery and non-infarct related artery
  • The reactive hyperemia index (RHI) [ Time Frame: 1 month and 1 year after primary PCI ]
  • Myocardial salvage [ Time Frame: 1 month after primary PCI ]
    measured with MRI
  • Left ventricular ejection fraction (LVEF) recovery [ Time Frame: 1 month after primary PCI ]
    measured with MRI
  • Microvascular obstruction [ Time Frame: 3 days after primary PCI ]
    measured with MRI
  • Asymmetric Dimethylarginine (ADMA) levels [ Time Frame: 1 month after primary PCI ]
    Blood measurements
  • Intra-myocardial haemorrhage [ Time Frame: 3 days after primary PCI ]
    measured with MRI
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2015)
  • Delta Index of microcirculatory resistance (IMR) [ Time Frame: Baseline vs. 1 month follow-up ]
    measured in the infarct-related artery and non-infarct related artery
  • The reactive hyperemia index (RHI) [ Time Frame: 1 month and 1 year after primary PCI ]
    measured with EndoPat
  • Myocardial salvage [ Time Frame: 1 month after primary PCI ]
    measured with MRI
  • LVEF recovery [ Time Frame: 1 month after primary PCI ]
    measured with MRI
  • Microvascular obstruction [ Time Frame: 3 days after primary PCI ]
    measured with MRI
  • ADMA [ Time Frame: 1 month after primary PCI ]
    Blood measurements
  • Intra-myocardial haemorrhage [ Time Frame: 3 days after primary PCI ]
    measured with MRI
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Micro Vascular Dysfunction in Acute Myocardial Infarction by Ticagrelor
Official Title  ICMJE Reducing Micro Vascular Dysfunction In Revascularized ST-elevation Myocardial Infarction Patients by Off-target Properties of Ticagrelor
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • Drug: 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.
    Other Name: Brilique
  • Drug: 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 Name: Efient
Study Arms  ICMJE
  • Experimental: Ticagrelor
    Ticagrelor 90 mg twice a day, tablet Duration: 1 year after PCI
    Intervention: Drug: Ticagrelor
  • Active Comparator: Prasugrel
    Prasugrel 10 mg once a day, tablet Duration: 1 year after PCI
    Intervention: Drug: Prasugrel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: April 16, 2015)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02422888
Other Study ID Numbers  ICMJE ESR-14-10048
2014-005363-33 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maarten van Leeuwen, VU University Medical Center
Study Sponsor  ICMJE VU University Medical Center
Collaborators  ICMJE
  • Erasmus Medical Center
  • Hospital San Carlos, Madrid
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • University Medical Center Nijmegen
Investigators  ICMJE Not Provided
PRS Account VU University Medical Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP