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

April 30, 2018 updated by: Maarten van Leeuwen, Amsterdam UMC, location VUmc

Reducing Micro Vascular Dysfunction In Revascularized ST-elevation Myocardial Infarction Patients by Off-target Properties of Ticagrelor

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • VU University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Efient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Index of microcirculatory resistance (IMR)
Time Frame: 1 month after primary PCI
measured in the infarct-related artery
1 month after primary PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline vs. 1 month follow-up
The reactive hyperemia index (RHI)
Time Frame: 1 month and 1 year after primary PCI
1 month and 1 year after primary PCI
Myocardial salvage
Time Frame: 1 month after primary PCI
measured with MRI
1 month after primary PCI
Left ventricular ejection fraction (LVEF) recovery
Time Frame: 1 month after primary PCI
measured with MRI
1 month after primary PCI
Microvascular obstruction
Time Frame: 3 days after primary PCI
measured with MRI
3 days after primary PCI
Asymmetric Dimethylarginine (ADMA) levels
Time Frame: 1 month after primary PCI
Blood measurements
1 month after primary PCI
Intra-myocardial haemorrhage
Time Frame: 3 days after primary PCI
measured with MRI
3 days after primary PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Collaborators

Erasmus Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Hospital San Carlos, Madrid
University Medical Center Nijmegen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-14-10048
  • 2014-005363-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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