Clinical Trials/NCT02429271

NCT02429271

Completed

Phase 3

A Multicenter Trial to Assess the MIcrovascular Integrity and Left Ventricular Function Recovery After Clopidogrel or TicagrelOr Administration, in Patients With STEMI Treated With Thrombolysis - The 'MIRTOS' Study

Hellenic Cardiovascular Research Society1 site in 1 country336 target enrollmentAugust 2015

ConditionsMyocardial Infarction ST Segment Elevation Myocardial Infarction (STEMI)

InterventionsTicagrelor Percutaneous Coronary Intervention (PCI)Coronary Angiography Clopidogrel

DrugsTicagrelor Clopidogrel

Overview

Phase: Phase 3
Intervention: Ticagrelor
Conditions: Myocardial Infarction
Sponsor: Hellenic Cardiovascular Research Society
Enrollment: 336
Locations: 1
Primary Endpoint: The difference in Post PCI Corrected TIMI Frame Count (CTFC) between the ticagrelor and clopidogrel treatment arms.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

February 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hellenic Cardiovascular Research Society

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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
•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.

Arms & Interventions

Ticagrelor

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

Intervention: Ticagrelor

Ticagrelor

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

Intervention: Percutaneous Coronary Intervention (PCI)

Ticagrelor

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

Intervention: Coronary Angiography

Clopidogrel

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

Intervention: Clopidogrel

Clopidogrel

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

Intervention: Percutaneous Coronary Intervention (PCI)

Clopidogrel

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

Intervention: Coronary Angiography

Outcomes

Primary Outcomes

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

Time Frame: 15 months after the initiation of the study.

Secondary Outcomes

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.)
The mean Left Ventricular Ejection Fraction (LVEF) 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.)