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Myocardial InfarctionPhase 4REDUCE-MVINCT02422888

Reducing Micro Vascular Dysfunction in Acute Myocardial Infarction by Ticagrelor

A Phase 4 study testing Ticagrelor and Prasugrel in people with Myocardial Infarction, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Ticagrelor and Prasugrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteNetherlands
Study dates
May 2015to Oct 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%)

Who cannot join

  • 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)
Show all 30Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • VU University Medical Center

    Amsterdam, North Holland, 1081 HV

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Ticagrelor, Prasugrel
Keywords
ST elevation myocardial infarction, Percutaneous coronary intervention, Endothelial function, Ticagrelor, Prasugrel
Medical subject headings
Myocardial Infarction, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TicagrelorDrug

    Also called Brilique

    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.

  • PrasugrelDrug

    Also called Efient

    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.

Study groups in NCT02422888
Study groupRoleWhat they receive
TicagrelorExperimentalTicagrelor 90 mg twice a day, tablet Duration: 1 year after PCI
Receives: Drug: Ticagrelor
PrasugrelActive comparatorPrasugrel 10 mg once a day, tablet Duration: 1 year after PCI
Receives: Drug: Prasugrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Index of microcirculatory resistance (IMR)

    measured in the infarct-related artery

    Measured: 1 month after primary PCI

Secondary outcomes (7)

  1. Delta Index of microcirculatory resistance (IMR)

    measured in the infarct-related artery and non-infarct related artery

    Measured: Baseline vs. 1 month follow-up

  2. The reactive hyperemia index (RHI)

    Measured: 1 month and 1 year after primary PCI

  3. Myocardial salvage

    measured with MRI

    Measured: 1 month after primary PCI

  4. Left ventricular ejection fraction (LVEF) recovery

    measured with MRI

    Measured: 1 month after primary PCI

  5. Microvascular obstruction

    measured with MRI

    Measured: 3 days after primary PCI

  6. Asymmetric Dimethylarginine (ADMA) levels

    Blood measurements

    Measured: 1 month after primary PCI

  7. Intra-myocardial haemorrhage

    measured with MRI

    Measured: 3 days after primary PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionOct 2017
  4. Study completionOct 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02422888
Sponsor's protocol ID
ESR-14-10048
Other IDs
2014-005363-33, 2014
Acronym
REDUCE-MVI
Status last verified
Apr 2018
First submitted
13 Apr 2015
Last updated
3 May 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37204397

  • 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.

    PubMed 32122216

  • 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.

    PubMed 30586720

  • 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.

    PubMed 27102290

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ticagrelor and Prasugrel in people with Myocardial Infarction, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Index of microcirculatory resistance (IMR) (time frame: 1 month after primary PCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02422888, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018; AzTrials last refreshed its copy on 30 Oct 2026.

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