NCT02422888

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

2.4 years

First QC Date

April 13, 2015

Last Update Submit

April 30, 2018

Conditions

Myocardial Infarction

Keywords

ST elevation myocardial infarctionPercutaneous coronary interventionEndothelial functionTicagrelorPrasugrel

Outcome Measures

Primary Outcomes (1)

  • Index of microcirculatory resistance (IMR)

    measured in the infarct-related artery

    1 month after primary PCI

Secondary Outcomes (7)

  • Delta Index of microcirculatory resistance (IMR)

    Baseline vs. 1 month follow-up

  • The reactive hyperemia index (RHI)

    1 month and 1 year after primary PCI

  • Myocardial salvage

    1 month after primary PCI

  • Left ventricular ejection fraction (LVEF) recovery

    1 month after primary PCI

  • Microvascular obstruction

    3 days after primary PCI

  • +2 more secondary outcomes

Study Arms (2)

Ticagrelor

EXPERIMENTAL

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

Drug: Ticagrelor

Prasugrel

ACTIVE COMPARATOR

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

Drug: Prasugrel

Interventions

TicagrelorDRUG

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.

Also known as: Brilique
Ticagrelor
PrasugrelDRUG

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.

Also known as: Efient
Prasugrel

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%)

You may not qualify if:

  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Related Publications (4)

  • 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.

    PMID: 37204397DERIVED

  • 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.

    PMID: 32122216DERIVED

  • 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.

    PMID: 30586720DERIVED

  • 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.

    PMID: 27102290DERIVED

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial Infarction

Interventions

TicagrelorPrasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study coordinator

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 21, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2019

Last Updated

May 3, 2018

Record last verified: 2018-04

Locations

NL(1)