Coronary Microvascular DiseaseNCT03104062
Effect of Ticagrelor and Clopidogrel on Coronary Microcirculation in Patients With Acute Myocardial Infarction
A study testing Microbubble Contrasted Echocardiography, Platelet Aggregability and Laboratory in people with Coronary Microvascular Disease and Ticagrelor, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Of the patients diagnosed with ST-segment elevation myocardial infarction (STEMI) who underwent reperfusion therapy and have thrombolysis in myocardial infarction (TIMI) 3 flow, about 40% have flow alterations in the coronary microcirculation, which leads to worse remodeling of the left ventricle with a consequent… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Microvascular Disease, Ticagrelor, Thrombolysis
- What is being tested?
- Microbubble Contrasted Echocardiography, Platelet Aggregability and Laboratory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2016to 1 Feb 2018
- Phase
- Interventional
- 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
- age from 18 years old to 75 years old.
- Patients with a ST-segment elevation AMI with up to 24 hours duration, documented by ischemic symptoms due to atherosclerosis> 10 minutes at rest, treated with pharmacological thrombolysis, acetylsalicylic acid (ASA) and Clopidogrel or Ticagrelor.
- Cardiac catheterization performed within 4 (± 2) days of the onset of symptoms, which at the end of coronary angiography showed residual obstruction in the "culprit" artery <50% with TIMI 3 flow regardless of whether or not the percutaneous coronary intervention was performed.
Who cannot join
- Previous infarction known from the same wall as the current one
- Any contraindication to the use of Clopidogrel or Ticagrelor
- Need for oral anticoagulation therapy or aspirin doses greater than 100mg per day.
- Concomitant oral or intravenous therapy with strong inhibitors of Cytochrome P450, family 3, subfamily A (CYP3A), Substrates of CYP3A with narrow therapeutic indices or strong inducers of CYP3A
- High risk of bradyarrhythmias
- Dialysis therapy
Show all 10Show fewer
- Clinically important thrombocytopenia known
- Clinically Significant Anemia
- Pregnancy or lactation
- Contraindications to fibrinolytic therapy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute (InCor) - University of Sao Paulo Medical School
São Paulo, 05403000
About this study
Of the patients diagnosed with ST-segment elevation myocardial infarction (STEMI) who underwent reperfusion therapy and have thrombolysis in myocardial infarction (TIMI) 3 flow, about 40% have flow alterations in the coronary microcirculation, which leads to worse remodeling of the left ventricle with a consequent increase in the mortality of this population. Clopidogrel is the only known antiplatelet medication that brings benefits to the coronary microcirculation. Ticagrelor is significantly superior to clopidogrel in terms of decreasing mortality.
The main objective of this study is to compare the effect of ticagrelor versus clopidogrel on the coronary microcirculation by the Myocardial Perfusion Score Index (MPSI) obtained using Microbubble Contrasted Echocardiography (MCE) in patients who have STEMI and treated with thrombolysis.
Read the detailed description
The present project should prospectively include patients participating in the TREAT study, who are including individuals with Acute Myocardial Infarction (AMI) treated with fibrinolytic and openly randomized to ticagrelor or clopidogrel within 24 hours of the onset of symptoms. Patients will be submitted to coronary angiography within 4 (± 2) days of the onset of symptoms, and those who, at the end of coronary angiography, present residual obstruction in the culprit vessel of less than 50% and have TIMI 3 flow, regardless of have undergone percutaneous coronary intervention will be included.
Following, on day 2 (± 1) days after coronary angiography (therefore 6 ± 3 days from the onset of symptoms), they will be submitted to microcirculation perfusion evaluation by means of MPSI (myocardial perfusion score index) obtained by MCE (Microbubble contrasted echocardiography) - blood collection for evaluation of Platelet aggregability will be performed immediately prior to the start of MCE. Finally, in order to evaluate left ventricular remodeling, patients will undergo a new Echocardiography within 90 (± 10) days after discharge.
- Conditions
- Coronary Microvascular Disease, Ticagrelor, Thrombolysis, Microbubble Contrasted Echocardiography
- Being tested
- Microbubble Contrasted Echocardiography, Platelet Aggregability, Laboratory
- Medical subject headings
- Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbubble Contrasted EchocardiographyDiagnostic test
Myocardial Perfusion Score Index (MPSI) obtained using Microbubble Contrasted Echocardiography
Platelet AggregabilityDiagnostic test
Obtained using Multiplate Analyzer
LaboratoryDiagnostic test
it will be collected at patients arrival, Reative C-Protein, BNP, CK-mass, Troponine, interleukine-6, Creatinine.
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Other | Patients will be randomized to have Ticagrelor 90mg BID Receives: Diagnostic Test: Microbubble Contrasted Echocardiography; Diagnostic Test: Platelet Aggregability; Diagnostic Test: Laboratory |
| Clopidogrel | Other | Patientes will be randomized to have Clopidogrel 75mg once a day Receives: Diagnostic Test: Microbubble Contrasted Echocardiography; Diagnostic Test: Platelet Aggregability; Diagnostic Test: Laboratory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Perfusion Score Index (MPSI)
Obtained using Microbubble Contrasted Echocardiography
Measured: 4 (±3) days after Cardiac catheterization
Secondary outcomes (7)
Left ventricular remodeling 90 days after de AMI, using Echocargiography parameters (End diastolic volume, end systolic volume and ejection Fraction)
To compare the parameters of left ventricular remodeling (End diastolic volume, End Systolic Volume, Ejection Fraction) at after 90 days after discharge from the ticagrelor and clopidogrel groups
Measured: after 90 days after discharge
number of myocardial segments with perfusion deficit in coronary microcirculation
To evaluate the number of myocardial segments with perfusion deficit in coronary microcirculation in the ticagrelor and clopidogrel groups
Measured: 4 (±3) days after Cardiac catheterization
MPSI in patients submitted to angioplasty
To evaluate MPSI in the subgroups of patients submitted to angioplasty and not submitted to angioplasty
Measured: 4 (±3) days after Cardiac catheterization
Patients who used clopidogrel prior to randomization and were randomized to ticagrelor
To evaluate MPSI in subgroups of patients who used clopidogrel prior to randomization and were randomized to ticagrelor
Measured: 4 (±3) days after Cardiac catheterization
Elective versus Urgent Percutaneous Coronary Intervention (PCI)
To compare the ticagrelor and clopidogrel groups in patients who had elective or urgent PCI
Measured: 4 (±3) days after Cardiac catheterization
Platelet aggregability
To evaluate the platelet aggregability in the ticagrelor and clopidogrel groups obtained immediately before Myocardial Contrasted Echocardiography (MCE) by Multiplate
Measured: 4 (±3) days after Cardiac catheterization
Time Ticagrelor or Clopidogrel is administered
Evaluate the main objective of the study in two subgroups: 1) Ticagrelor or Clopidogrel administered less than 12 hours from the symptoms onset. 2) greater than or equal to 12 hours from the symptoms onset
Measured: 4 (±3) days after Cardiac catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start1 Oct 2016
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
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 Coronary Microvascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Antonio Scanavini Filho, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104062
- Sponsor's protocol ID
- 4416
- Status last verified
- May 2018
- First submitted
- 17 Mar 2017
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scanavini-Filho MA, Berwanger O, Matthias W, Aguiar MO, Chiang HP, Azevedo L, Baracioli LM, Lima FG, Furtado RHM, Dalcoquio TF, Menezes FR, Ferrari AG, de Luca F, Giugliano RP, Goodman S, Nicolau JC. Effects of Ticagrelor and Clopidogrel on Coronary Microcirculation in Patients with Acute Myocardial Infarction. Adv Ther. 2022 Apr;39(4):1832-1843. doi: 10.1007/s12325-022-02061-0. Epub 2022 Feb 26.
PubMed 35218519
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ticagrelor and Clopidogrel on Coronary Microcirculation in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03104062
- Acronym / sponsor ID
- 4416
- Conditions
- Coronary Microvascular Disease, Ticagrelor, Thrombolysis, Microbubble Contrasted Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 7 Apr 2017 (actual)
- 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.
Of the patients diagnosed with ST-segment elevation myocardial infarction (STEMI) who underwent reperfusion therapy and have thrombolysis in myocardial infarction (TIMI) 3 flow, about 40% have flow alterations in the coronary microcirculation, which leads to worse remodeling of the left ventricle with a consequent increase in the mortality of this population. Clopidogrel is the only known antiplatelet medication that brings benefits to the coronary microcirculation. Ticagrelor is significantly superior to clopidogrel in terms of decreasing mortality.
The main objective of this study is to compare the effect of ticagrelor versus clopidogrel on the coronary microcirculation by the Myocardial Perfusion Score Index (MPSI) obtained using Microbubble Contrasted Echocardiography (MCE) in patients who have STEMI and treated with thrombolysis.
Detailed description
The present project should prospectively include patients participating in the TREAT study, who are including individuals with Acute Myocardial Infarction (AMI) treated with fibrinolytic and openly randomized to ticagrelor or clopidogrel within 24 hours of the onset of symptoms. Patients will be submitted to coronary angiography within 4 (± 2) days of the onset of symptoms, and those who, at the end of coronary angiography, present residual obstruction in the culprit vessel of less than 50% and have TIMI 3 flow, regardless of have undergone percutaneous coronary intervention will be included.
Following, on day 2 (± 1) days after coronary angiography (therefore 6 ± 3 days from the onset of symptoms), they will be submitted to microcirculation perfusion evaluation by means of MPSI (myocardial perfusion score index) obtained by MCE (Microbubble contrasted echocardiography) - blood collection for evaluation of Platelet aggregability will be performed immediately prior to the start of MCE. Finally, in order to evaluate left ventricular remodeling, patients will undergo a new Echocardiography within 90 (± 10) days after discharge.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Other | Diagnostic Test: Microbubble Contrasted Echocardiography, Diagnostic Test: Platelet Aggregability, Diagnostic Test: LaboratoryPatients will be randomized to have Ticagrelor 90mg BID |
| Clopidogrel | Other | Diagnostic Test: Microbubble Contrasted Echocardiography, Diagnostic Test: Platelet Aggregability, Diagnostic Test: LaboratoryPatientes will be randomized to have Clopidogrel 75mg once a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age from 18 years old to 75 years old.
- Patients with a ST-segment elevation AMI with up to 24 hours duration, documented by ischemic symptoms due to atherosclerosis> 10 minutes at rest, treated with pharmacological thrombolysis, acetylsalicylic acid (ASA) and Clopidogrel or Ticagrelor.
- Cardiac catheterization performed within 4 (± 2) days of the onset of symptoms, which at the end of coronary angiography showed residual obstruction in the "culprit" artery <50% with TIMI 3 flow regardless of whether or not the percutaneous coronary intervention was performed.
Key exclusion criteria (10 listed)
- Previous infarction known from the same wall as the current one
- Any contraindication to the use of Clopidogrel or Ticagrelor
- Need for oral anticoagulation therapy or aspirin doses greater than 100mg per day.
- Concomitant oral or intravenous therapy with strong inhibitors of Cytochrome P450, family 3, subfamily A (CYP3A), Substrates of CYP3A with narrow therapeutic indices or strong inducers of CYP3A
- High risk of bradyarrhythmias
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 |
|---|---|---|
| Microbubble Contrasted EchocardiographyMyocardial Perfusion Score Index (MPSI) obtained using Microbubble Contrasted Echocardiography | Diagnostic test | Clopidogrel, Ticagrelor |
| Platelet AggregabilityObtained using Multiplate Analyzer | Diagnostic test | Clopidogrel, Ticagrelor |
| Laboratoryit will be collected at patients arrival, Reative C-Protein, BNP, CK-mass, Troponine, interleukine-6, Creatinine. | Diagnostic test | Clopidogrel, Ticagrelor |
Primary outcome
Myocardial Perfusion Score Index (MPSI)
Time frame: 4 (±3) days after Cardiac catheterization
Obtained using Microbubble Contrasted Echocardiography
7 secondary outcomes
Left ventricular remodeling 90 days after de AMI, using Echocargiography parameters (End diastolic volume, end systolic volume and ejection Fraction)
Time frame: after 90 days after discharge
number of myocardial segments with perfusion deficit in coronary microcirculation
Time frame: 4 (±3) days after Cardiac catheterization
MPSI in patients submitted to angioplasty
Time frame: 4 (±3) days after Cardiac catheterization
Patients who used clopidogrel prior to randomization and were randomized to ticagrelor
Time frame: 4 (±3) days after Cardiac catheterization
Elective versus Urgent Percutaneous Coronary Intervention (PCI)
Time frame: 4 (±3) days after Cardiac catheterization
Platelet aggregability
Time frame: 4 (±3) days after Cardiac catheterization
Time Ticagrelor or Clopidogrel is administered
Time frame: 4 (±3) days after Cardiac catheterization
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 18 May 2018.
- Derived from this study: PubMed 35218519Scanavini-Filho MA, Berwanger O, Matthias W, Aguiar MO, Chiang HP, Azevedo L, Baracioli LM, Lima FG, Furtado RHM, Dalcoquio TF, Menezes FR, Ferrari AG, de Luca F, Giugliano RP, Goodman S, Nicolau JC. Effects of Ticagrelor and Clopidogrel on Coronary Microcirculation in Patients with Acute Myocardial Infarction. Adv Ther. 2022 Apr;39(4):1832-1843. doi: 10.1007/s12325-022-02061-0. Epub 2022 Feb 26.
- Individual participant dataSharing planned: No
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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 study testing Microbubble Contrasted Echocardiography, Platelet Aggregability and Laboratory in people with Coronary Microvascular Disease and Ticagrelor, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 inclusion and 10 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 18 May 2018. 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 Brazil. 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.
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?
Myocardial Perfusion Score Index (MPSI) (time frame: 4 (±3) days after Cardiac catheterization). 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 NCT03104062, 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 18 May 2018.