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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02429271
• Date of registration: 17/04/2015
• Prospective Registration: Yes
• Primary sponsor: Hellenic Cardiovascular Research Society
• Public title: 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 MIRTOS
• Scientific title: 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
• Date of first enrolment: August 2015
• Target sample size: 336
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02429271
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Greece

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures.

2. Male and female subjects, 18-75 years of age (both inclusive).

3. STEMI eligible for thrombolysis

4. Inability to perform primary PCI, because of transport time in centers carrying out
primary PCI lasting more than two hours

5. 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:

1. Inability to give informed consent.

2. Pre-treatment with any inhibitor of the purinergic receptor P2Y, G-protein coupled, 12
(P2Y12) within the 7-day period prior to randomization.

3. Cardiogenic shock - according to Killip classification - class 4.

4. Suspicion or evidence of mechanical complication, including mitral valve dysfunction,
ventricular septal rupture, and rupture of the left ventricle.

5. Current use of warfarin or other anticoagulant drug.

6. Known multivessel coronary artery disease not suitable for revascularization.

7. 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).

8. Other bleeding diathesis, or considered by Investigator to be at high risk for
bleeding.

9. Any kind of stroke in the past year or haemorrhagic stroke ever.

10. Severe uncontrolled hypertension (>180/110 mmHg) prior to randomisation.

11. Prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) in the last 2
weeks.

12. Known thrombocytopenia defined as platelet count of <100,000/mm3.

13. Known anemia (hemoglobin [Hb] <10 gr/dL).

14. 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.

15. Chronic dialysis or known chronic renal failure (glomerular filtration rate (GFR)<30
ml/min/1.73m2).

16. Known moderate or severe hepatic impairment.

17. Severe uncontrolled chronic obstructive pulmonary disease.

18. Concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (atazanavir,
clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir,
ritonavir, saquinavir, telithromycin and voriconazole, grapefruit juice over 1 litre
daily), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or
inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and
rifapentine).

19. Concomitant use of drugs that are metabolized through cytochrome P450, family 2,
subfamily C, polypeptide 19 (CYP2C19) (omeprazole and esomeprazole, fluvoxamine,
fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin,
cimetidine, carbamazepine, oxcarbazepine and chloramphenicol).

20. Increased risk of bradycardic events (e.g. known sick sinus syndrome or third degree
atrioventricular (AV) block or previous documented syncope suspected to be due to
bradycardia unless treated with a pacemaker).

21. Any known contraindication to clopidogrel, Acetylsalicylic Acid (ASA), or ticagrelor.

22. Current pregnancy, active lactation or parturition (childbirth) within the previous 30
days; women of childbearing potential must have a negative urine pregnancy test, or
use a medically accepted method of birth control.

23. Treatment with other investigational agents (including placebo) or devices within 30
days prior to randomization or planned use of investigational agents or devices prior
to the completion of study participation.

24. Any non-cardiac condition with life expectancy less than 1 year.

25. Inability to adhere to the follow-up requirements or any other reason or condition
that the investigator feels would place the patient at increased risk if the
investigational therapy is initiated.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

ST Segment Elevation Myocardial Infarction (STEMI)

Myocardial Infarction

Intervention(s)

Drug: Ticagrelor

Drug: Clopidogrel

Procedure: Percutaneous Coronary Intervention (PCI)

Procedure: Coronary Angiography

Primary Outcome(s)

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 Outcome(s)

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

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

Secondary ID(s)

D5130C00137

Source(s) of Monetary Support

Please refer to primary and secondary sponsors