Non ST Segment Elevation Acute Coronary SyndromePhase 4TIGER-MNCT02071966
Study of Effects of Ticagrelor on Microparticles and Micro-RNA in NSTE-ACS
A Phase 4 study testing Ticagrelor and Clopidogrel in people with Non ST Segment Elevation Acute Coronary Syndrome, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The aim of the study is to learn more about the pathophysiology of acute coronary syndrome (ACS) and to evaluate the mechanisms responsible of the action and benefits of ticagrelor. Ticagrelor is an oral and reversible inhibitor of P2Y12 receptor. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Non ST Segment Elevation Acute Coronary Syndrome
- What is being tested?
- Ticagrelor and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2012to Nov 2016
- Phase
- Phase 4
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NSTE-ACS
- Male, 50-80 years old
- Female, postmenopausal age
Who cannot join
- Female, premenopausal age
- autoimmune disease
- infectious disease
- neoplasms
- diabetes
- chronic renal failure
Show all 17Show fewer
- moderate or severe liver insufficiency
- GRACE risk score>140
- ACS or cerebrovascular accidents in previous three months
- in-stent restenosis
- surgery or trauma in previous three months
- active bleeding
- fibrinolytic therapy within 24 hours before randomization
- need for oral anticoagulation therapy
- an increased risk of bradycardia
- drugs study hypersensitivity (including aspirin)
- co-administration of ticagrelor or clopidogrel with strong CYP3A4 inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of TIcaGREloR on Circulating Microparticles and Micro-RNAs in Patients With Non ST Elevation Acute Coronary Syndromes
The aim of the study is to learn more about the pathophysiology of acute coronary syndrome (ACS) and to evaluate the mechanisms responsible of the action and benefits of ticagrelor.
Ticagrelor is an oral and reversible inhibitor of P2Y12 receptor. Few information is available about the action of ticagrelor on the molecules involved in thrombogenesis and platelets activation in ACS.
Read more
The aim of this study is to evaluate the mechanisms of ticagrelor action in vivo.
It was observed that patients with myocardial infarction have higher blood levels of microparticles than patients with unstable angina or stable angina.
The investigators assumed that ticagrelor benefits are represented by a reduction of microparticle levels, a marker of endothelial dysfunction in patients with cardiovascular disease, and by a modification in microRNAs pattern, fragments of mRNA that have a regulatory action in various cellular processes (such as proliferation, differentiation, growth and cellular death) and represent new biomarkers in ACS.
Read the detailed description
Ticagrelor is an oral, reversibly binding P2Y12 receptor inhibitor that yields, in a dose-dependent fashion, greater and more consistent inhibition of platelet aggregation than standard regimens of clopidogrel in patients with stable atherosclerotic disease and ACS. However, little information is available regarding its complex effect on thrombogenesis and platelet activation in acute coronary syndromes setting. It has been widely demonstrated the potential role of MP in several biologic processes known to take part to pathophysiology of coronary syndromes, such as inflammation, coagulation and apoptosis. Recent studies focused on miRNAs' regulatory activity of several cellular processes, such as proliferation, differentiation, development, and cell death, and on their role as biomarkers in ACS. The investigators suppose that the observed major efficacy of ticagrelor is related to its actions on MP and microRNAs. Considering the major clinical effectiveness shown by ticagrelor in comparison with clopidogrel, the investigators hypothesize a more pronounced MP levels reduction as a possible mechanism for ticagrelor clinical benefits. Moreover, on the basis of the last evidences of microRNA involvement in the ACS pathophysiology, the investigators aim to assess the effect of ticagrelor on microRNA expression, in order to provide evidences for pleiotropic actions of this drug, which could partially explain its major efficacy in reduction of cardiovascular events in ACS patients.
In summary, principal hypothesis of the study are:
- Considering that ticagrelor is a stronger P2Y12 receptor inhibitor than clopidogrel, the investigators suppose that an increased inhibition of P2Y12 receptor by ticagrelor could reduce circulating levels of platelet and endothelial MP.
- In consideration of the observed role of microRNAs in expression of P2Y12 receptor, the investigators speculate that patient's susceptibility to P2Y12 receptor inhibitors could be influenced by microRNAs levels. Moreover, the investigators suppose that ticagrelor could influence microRNAs levels, considered as marker of cardiovascular risk
Aims of the study are:
- to assess MP levels variation in Non ST-Elevation Acute Coronary Syndromes (NSTE-ACS) patients treated with ticagrelor in addition to low or high acetyl-salicylic acid (ASA), in comparison with clopidogrel+ASA treatment, to demonstrate that major clinical efficacy of ticagrelor could be partially attributed to its influence on release of MP, that have an important role in coronary instability.
- to evaluate microRNAs levels variation in Non ST-Elevation Acute Coronary Syndromes (NSTE-ACS) patients treated with ticagrelor in addition to low or high ASA, in comparison with clopidogrel+ASA treatment, and to study possible correlations between microRNAs and MP levels, supposing that the ability of ticagrelor in reduced MP level could be related with microRNAs expression.
- Being tested
- Ticagrelor, Clopidogrel
- Keywords
- Micro-RNA, Microparticles, Ticagrelor, NSTE-ACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilique
Comparison of Ticagrelor with another anti-platelet drug (Clopidogrel)
ClopidogrelDrug
Also called Plavix
Comparison of Clopidogrel with another anti-platelet drug (Ticagrelor)
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Active comparator | Ticagrelor: oral, 180 mg once for the first dose then 90 mg twice a day Receives: Drug: Ticagrelor |
| Clopidogrel | Active comparator | Clopidogrel: oral, 300 or 600 mg once for the first dose, 75 mg once a day Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Micro-RNA and microparticles
Measured: up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startNov 2012
- Primary completionDec 2015
- Study completionNov 2016 (estimated)
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non ST Segment Elevation Acute Coronary SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, L.M. Biasucci, Catholic University of the Sacred Heart
- Investigators
- Luigi M Biasucci, Professor, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071966
- Sponsor's protocol ID
- D5130L00028
- Acronym
- TIGER-M
- Status last verified
- Jul 2016
- First submitted
- 21 Feb 2014
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of TIcaGREloR on Circulating Microparticles and Micro-RNAs in Patients With Non ST Elevation Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT02071966
- Acronym / sponsor ID
- TIGER-M / D5130L00028
- Keywords
- Micro-RNA, Microparticles, Ticagrelor, NSTE-ACS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Nov 2016 (estimated)
- First posted
- 26 Feb 2014 (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.
The aim of the study is to learn more about the pathophysiology of acute coronary syndrome (ACS) and to evaluate the mechanisms responsible of the action and benefits of ticagrelor.
Ticagrelor is an oral and reversible inhibitor of P2Y12 receptor. Few information is available about the action of ticagrelor on the molecules involved in thrombogenesis and platelets activation in ACS.
The aim of this study is to evaluate the mechanisms of ticagrelor action in vivo.
It was observed that patients with myocardial infarction have higher blood levels of microparticles than patients with unstable angina or stable angina.
The investigators assumed that ticagrelor benefits are represented by a reduction of microparticle levels, a marker of endothelial dysfunction in patients with cardiovascular disease, and by a modification in microRNAs pattern, fragments of mRNA that have a regulatory action in various cellular processes (such as proliferation, differentiation, growth and cellular death) and represent new biomarkers in ACS.
Detailed description
Ticagrelor is an oral, reversibly binding P2Y12 receptor inhibitor that yields, in a dose-dependent fashion, greater and more consistent inhibition of platelet aggregation than standard regimens of clopidogrel in patients with stable atherosclerotic disease and ACS. However, little information is available regarding its complex effect on thrombogenesis and platelet activation in acute coronary syndromes setting. It has been widely demonstrated the potential role of MP in several biologic processes known to take part to pathophysiology of coronary syndromes, such as inflammation, coagulation and apoptosis. Recent studies focused on miRNAs' regulatory activity of several cellular processes, such as proliferation, differentiation, development, and cell death, and on their role as biomarkers in ACS. The investigators suppose that the observed major efficacy of ticagrelor is related to its actions on MP and microRNAs. Considering the major clinical effectiveness shown by ticagrelor in comparison with clopidogrel, the investigators hypothesize a more pronounced MP levels reduction as a possible mechanism for ticagrelor clinical benefits. Moreover, on the basis of the last evidences of microRNA involvement in the ACS pathophysiology, the investigators aim to assess the effect of ticagrelor on microRNA expression, in order to provide evidences for pleiotropic actions of this drug, which could partially explain its major efficacy in reduction of cardiovascular events in ACS patients.
In summary, principal hypothesis of the study are:
- Considering that ticagrelor is a stronger P2Y12 receptor inhibitor than clopidogrel, the investigators suppose that an increased inhibition of P2Y12 receptor by ticagrelor could reduce circulating levels of platelet and endothelial MP.
- In consideration of the observed role of microRNAs in expression of P2Y12 receptor, the investigators speculate that patient's susceptibility to P2Y12 receptor inhibitors could be influenced by microRNAs levels. Moreover, the investigators suppose that ticagrelor could influence microRNAs levels, considered as marker of cardiovascular risk
Aims of the study are:
- to assess MP levels variation in Non ST-Elevation Acute Coronary Syndromes (NSTE-ACS) patients treated with ticagrelor in addition to low or high acetyl-salicylic acid (ASA), in comparison with clopidogrel+ASA treatment, to demonstrate that major clinical efficacy of ticagrelor could be partially attributed to its influence on release of MP, that have an important role in coronary instability.
- to evaluate microRNAs levels variation in Non ST-Elevation Acute Coronary Syndromes (NSTE-ACS) patients treated with ticagrelor in addition to low or high ASA, in comparison with clopidogrel+ASA treatment, and to study possible correlations between microRNAs and MP levels, supposing that the ability of ticagrelor in reduced MP level could be related with microRNAs expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Active comparator | Drug: TicagrelorTicagrelor: oral, 180 mg once for the first dose then 90 mg twice a day |
| Clopidogrel | Active comparator | Drug: ClopidogrelClopidogrel: oral, 300 or 600 mg once for the first dose, 75 mg once a day |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- NSTE-ACS
- Male, 50-80 years old
- Female, postmenopausal age
Key exclusion criteria (17 listed)
- Female, premenopausal age
- autoimmune disease
- infectious disease
- neoplasms
- diabetes
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: BriliqueComparison of Ticagrelor with another anti-platelet drug (Clopidogrel) | Drug | Ticagrelor |
| ClopidogrelAlso: PlavixComparison of Clopidogrel with another anti-platelet drug (Ticagrelor) | Drug | Clopidogrel |
Primary outcome
Micro-RNA and microparticles
Time frame: up to three months
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
Related trials for Non ST Segment Elevation Acute Coronary Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 4
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
RecruitingObservational study
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT)
Active, not recruiting
Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
Acute Chest Pain, NSTEMI - Non-ST Segment Elevation MI
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.
Luigi M Biasucci, Professor principal investigator
Catholic University of the Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor and Clopidogrel in people with Non ST Segment Elevation Acute Coronary Syndrome, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 17 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: stopped early, as of the sponsor's last update on 26 Jul 2016. 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: slow enrollment). Results are not available in the source record.
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?
Micro-RNA and microparticles (time frame: up to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2016.