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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Ticagrelor Drug: Prasugrel Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Micro Vascular Dysfunction In Revascularized ST-elevation Myocardial Infarction Patients by Off-target Properties of Ticagrelor
Actual Study Start Date : May 2015
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Ticagrelor
Ticagrelor 90 mg twice a day, tablet Duration: 1 year after PCI
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

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




Primary Outcome Measures :
  1. Index of microcirculatory resistance (IMR) [ Time Frame: 1 month after primary PCI ]
    measured in the infarct-related artery


Secondary Outcome Measures :
  1. 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

  2. The reactive hyperemia index (RHI) [ Time Frame: 1 month and 1 year after primary PCI ]
  3. Myocardial salvage [ Time Frame: 1 month after primary PCI ]
    measured with MRI

  4. Left ventricular ejection fraction (LVEF) recovery [ Time Frame: 1 month after primary PCI ]
    measured with MRI

  5. Microvascular obstruction [ Time Frame: 3 days after primary PCI ]
    measured with MRI

  6. Asymmetric Dimethylarginine (ADMA) levels [ Time Frame: 1 month after primary PCI ]
    Blood measurements

  7. Intra-myocardial haemorrhage [ Time Frame: 3 days after primary PCI ]
    measured with MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02422888


Locations
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Netherlands
VU University Medical Center
Amsterdam, Noord-Holland, Netherlands, 1081 HV
Sponsors and Collaborators
VU University Medical Center
Erasmus Medical Center
Hospital San Carlos, Madrid
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Medical Center Nijmegen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maarten van Leeuwen, Study coordinator, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02422888    
Other Study ID Numbers: ESR-14-10048
2014-005363-33 ( EudraCT Number )
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Keywords provided by Maarten van Leeuwen, VU University Medical Center:
ST elevation myocardial infarction
Percutaneous coronary intervention
Endothelial function
Ticagrelor
Prasugrel
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs