Myocardial InfarctionPhase 3MIRTOSNCT02429271
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
A Phase 3 study testing Ticagrelor, Clopidogrel and Percutaneous Coronary Intervention (PCI) in people with Myocardial Infarction and ST Segment Elevation Myocardial Infarction (STEMI), run by Hellenic Cardiovascular Research Society at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction, ST Segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Ticagrelor, Clopidogrel and Percutaneous Coronary Intervention (PCI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteGreece
- Study dates
- Aug 2015to Feb 2019
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
- Known moderate or severe hepatic impairment.
- Severe uncontrolled chronic obstructive pulmonary disease.
- 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).
- 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).
- 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).
- Any known contraindication to clopidogrel, Acetylsalicylic Acid (ASA), or ticagrelor.
- 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.
- 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.
- Any non-cardiac condition with life expectancy less than 1 year.
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
General Hospital of Heraklion Venizeleio-Pananeio
Heraklion, Crete, 71409
About this study
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.
- Being tested
- Ticagrelor, Clopidogrel, Percutaneous Coronary Intervention (PCI), Coronary Angiography
- Keywords
- undergoing thrombolysis
- 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
ClopidogrelDrug
Also called Plavix
Percutaneous Coronary Intervention (PCI)Procedure or surgery
Coronary AngiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Active comparator | 1st day 270 mg \& from then onwards 180 mg per day Receives: Drug: Ticagrelor; Procedure: Percutaneous Coronary Intervention (PCI); Procedure: Coronary Angiography |
| Clopidogrel | Active comparator | 1st day 300 mg \& from then onwards 75 mg per day Receives: Drug: Clopidogrel; Procedure: Percutaneous Coronary Intervention (PCI); Procedure: Coronary Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in Post PCI Corrected TIMI Frame Count (CTFC) between the ticagrelor and clopidogrel treatment arms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 months after the initiation of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cardiovascular Research Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429271
- Sponsor's protocol ID
- D5130C00137
- Acronym
- MIRTOS
- Status last verified
- Nov 2019
- First submitted
- 17 Apr 2015
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32715996
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02429271
- Acronym / sponsor ID
- MIRTOS / D5130C00137
- Keywords
- undergoing thrombolysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Hellenic Cardiovascular Research SocietyUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Active comparator | Drug: Ticagrelor, Procedure: Percutaneous Coronary Intervention (PCI), Procedure: Coronary Angiography1st day 270 mg \& from then onwards 180 mg per day |
| Clopidogrel | Active comparator | Drug: Clopidogrel, Procedure: Percutaneous Coronary Intervention (PCI), Procedure: Coronary Angiography1st day 300 mg \& from then onwards 75 mg per day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorAlso: Brilique | Drug | Ticagrelor |
| ClopidogrelAlso: Plavix | Drug | Clopidogrel |
| Percutaneous Coronary Intervention (PCI) | Procedure or surgery | Clopidogrel, Ticagrelor |
| Coronary Angiography | Procedure or surgery | Clopidogrel, Ticagrelor |
Primary outcome
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.
6 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.
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 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.
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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Derived from this study: PubMed 32715996Hamilos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ticagrelor, Clopidogrel and Percutaneous Coronary Intervention (PCI) in people with Myocardial Infarction and ST Segment Elevation Myocardial Infarction (STEMI), run by Hellenic Cardiovascular Research Society at 1 site in Greece.
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 5 inclusion and 25 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: finished, as of the sponsor's last update on 22 Nov 2019. 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 Greece. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.). 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 NCT02429271, which also lists 1 linked publication.
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 22 Nov 2019.