NCT02429271

Brief Summary

This is a prospective randomized study, which investigates the coronary microvascular function as assessed by coronary angiography after administration of ticagrelor compared with clopidogrel in patients with myocardial infarction and ST segment elevation after thrombolysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
336

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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 17, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

3.5 years

First QC Date

April 17, 2015

Last Update Submit

November 21, 2019

Conditions

Myocardial InfarctionST Segment Elevation Myocardial Infarction (STEMI)

Keywords

undergoing thrombolysis

Outcome Measures

Primary Outcomes (1)

  • The difference in Post PCI Corrected TIMI Frame Count (CTFC) between the ticagrelor and clopidogrel treatment arms.

    15 months after the initiation of the study.

Secondary Outcomes (6)

  • The rates of TIMI Myocardial Perfusion Grade (TMPG) and the difference in the incidence of normal TMPG (3) following PCI between the ticagrelor and clopidogrel treatment arms.

    15 months after the initiation of the study.

  • The rates of Pre and Post PCI TIMI Flow Grade (TFG) and the difference in the incidence normal epicardial flow (TFG 3) following PCI between the ticagrelor and clopidogrel treatment arms.

    15 months after the initiation of the study.

  • The rates of full, partial and failed perfusion as assessed by the Angiographic Perfusion Score (APS) and the between treatment difference.

    15 months after the initiation of the study.

  • The rates of Thrombolysis In Myocardial Infarction (TIMI) thrombus grades Pre and Post PCI and the difference in the incidence of thrombus grade '0' following PCI between the ticagrelor and clopidogrel treatment arms.

    15 months after the initiation of the study.

  • The mean Global Longitudinal Strain (GLS) and Regional Longitudinal Strain (RLS) within 48 hours and at 30 and 90 days following PCI in the ticagrelor and clopidogrel treatment arms, and the between treatment difference.

    15 months after the initiation of the study.

  • +1 more secondary outcomes

Study Arms (2)

Ticagrelor

ACTIVE COMPARATOR

1st day 270 mg \& from then onwards 180 mg per day

Drug: TicagrelorProcedure: Percutaneous Coronary Intervention (PCI)Procedure: Coronary Angiography

Clopidogrel

ACTIVE COMPARATOR

1st day 300 mg \& from then onwards 75 mg per day

Drug: ClopidogrelProcedure: Percutaneous Coronary Intervention (PCI)Procedure: Coronary Angiography

Interventions

TicagrelorDRUG
Also known as: Brilique
Ticagrelor
ClopidogrelDRUG
Also known as: Plavix
Clopidogrel
Percutaneous Coronary Intervention (PCI)PROCEDURE
ClopidogrelTicagrelor
Coronary AngiographyPROCEDURE
ClopidogrelTicagrelor

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent prior to any study specific procedures.
  • Male and female subjects, 18-75 years of age (both inclusive).
  • STEMI eligible for thrombolysis
  • Inability to perform primary PCI, because of transport time in centers carrying out primary PCI lasting more than two hours
  • Ability of transportation in 3-24 hours after thrombolysis in order to perform coronary angiography and PCI. This period may be extended for reasons of extreme importance up to 72 hours at the latest.

You may not qualify if:

  • Inability to give informed consent.
  • Pre-treatment with any inhibitor of the purinergic receptor P2Y, G-protein coupled, 12 (P2Y12) within the 7-day period prior to randomization.
  • Cardiogenic shock - according to Killip classification - class 4.
  • Suspicion or evidence of mechanical complication, including mitral valve dysfunction, ventricular septal rupture, and rupture of the left ventricle.
  • Current use of warfarin or other anticoagulant drug.
  • Known multivessel coronary artery disease not suitable for revascularization.
  • Any contraindication to thrombolytic therapy -Central nervous system damage or neoplasms or atrioventricular malformation -Recent major trauma/surgery/head injury (within the preceding 3 weeks) -Gastrointestinal bleeding within the past month -Known bleeding disorder (excluding menses) -Aortic dissection -Non-compressible punctures in the past 24 hours (e.g. liver biopsy, lumbar puncture).
  • Other bleeding diathesis, or considered by Investigator to be at high risk for bleeding.
  • Any kind of stroke in the past year or haemorrhagic stroke ever.
  • Severe uncontrolled hypertension (\>180/110 mmHg) prior to randomisation.
  • Prolonged or traumatic cardiopulmonary resuscitation (\> 10 minutes) in the last 2 weeks.
  • Known thrombocytopenia defined as platelet count of \<100,000/mm3.
  • Known anemia (hemoglobin \[Hb\] \<10 gr/dL).
  • Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
  • Chronic dialysis or known chronic renal failure (glomerular filtration rate (GFR)\<30 ml/min/1.73m2).
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Heraklion Venizeleio-Pananeio

Heraklion, Crete, 71409, Greece

Location

Related Publications (1)

  • Hamilos M, Kanakakis J, Anastasiou I, Karvounis C, Vasilikos V, Goudevenos J, Michalis L, Koutouzis M, Tsiafoutis I, Raisakis K, Stakos D, Hahalis G, Vardas P; Collaborators. Ticagrelor versus clopidogrel in patients with STEMI treated with thrombolysis: the MIRTOS trial. EuroIntervention. 2021 Feb 19;16(14):1163-1169. doi: 10.4244/EIJ-D-20-00268.

    PMID: 32715996DERIVED

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial Infarction

Interventions

TicagrelorClopidogrelPercutaneous Coronary Intervention

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 NucleosidesRibonucleosidesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2015

First Posted

April 29, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations

GR(1)