Myocardial InfarctionPhase 4AFFECT EVNCT02931045
Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction
A Phase 4 study testing Ticagrelor and Clopidogrel in people with Myocardial Infarction, run by Medical University of Warsaw at 2 sites in 2 countries.
Trial summary
Platelet activation and aggregation leads to myocardial infarction. Platelet P2Y12 receptors are essential for platelet activation. Antagonists against the P2Y12 receptor, which are established in secondary prevention of myocardial infarction, have unexplained anti-inflammatory effects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- 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
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Dec 2017to 30 Dec 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Informed consent to participate in the study
- Percutaneous coronary intervention with stent implantation due to first S T elevation myocardial infarction, or first non S T -elevation myocardial infarction
- Administration of a loading dose of clopidogrel
Who cannot join
- Known coagulopathy
- Known history of bleeding disorder
- Suspicion of intracranial haemorrhage
- Need for oral anticoagulation therapy
- Administration of glycoprotein (GP) II b - III a antagonists
- Cardiogenic shock
Show all 17Show fewer
- Severe chronic renal failure (estimated glomerular filtration rate < 30 mL/min)
- Severe liver insufficiency
- Chronic dyspnea
- Increased risk of bradycardia
- Autoimmune disease
- Infectious disease
- Neoplasms
- Pregnancy
- Study drug intolerance
- Co-administration of ticagrelor or clopidogrel with strong CYP3A4 inhibitors
- Participation in any previous study with ticagrelor or clopidogrel
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Laboratory of Experimental Clinical Chemistry, Academic Medical Centre of the University of Amsterdam
Amsterdam
Poland1 site
1st Chair and Department of Cardiology, Medical University of Warsaw
Warsaw
About this study
Official title: Antiplatelet Therapy Effect on Platelet Extracellular Vesicles in Acute Myocardial Infarction
Platelet activation and aggregation leads to myocardial infarction. Platelet P2Y12 receptors are essential for platelet activation. Antagonists against the P2Y12 receptor, which are established in secondary prevention of myocardial infarction, have unexplained anti-inflammatory effects. A novel P2Y12 receptor antagonist ticagrelor reduced infection-related mortality compared to clopidogrel, previous standard treatment for patients with myocardial infarction. Activated platelets release pro-inflammatory and procoagulant platelet extracellular vesicles. The investigators assume that decrease in infection-related mortality in patients treated with ticagrelor may be explained by greater inhibition of the release of platelet vesicles by ticagrelor, compared to clopidogrel. This study is expected to identify an additional mechanism of action of ticagrelor, which might contribute to the observed clinical benefits in patients treated with ticagrelor.
- Conditions
- Myocardial Infarction
- Being tested
- Ticagrelor, Clopidogrel
- Keywords
- extracellular vesicles, inflammation, thrombosis, antiplatelet drugs
- Medical subject headings
- Myocardial Infarction, Inflammation, Thrombosis
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 antiplatelet drug (clopidogrel)
ClopidogrelDrug
Also called Plavix
Comparison of clopidogrel with another antiplatelet drug (ticagrelor)
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Active comparator | Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose) Receives: Drug: Ticagrelor |
| Clopidogrel | Active comparator | Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose) Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Platelet Extracellular Vesicles/ml
Concentration of platelet extracellular vesicles/ml measured with flow cytometry
Measured: 6 months following the beginning of antiplatelet therapy
Secondary outcomes (4)
Concentration of Extracellular Vesicles Exposing Fibrinogen
Concentration of extracellular vesicles exposing fibrinogen/ ml measured with flow cytometry
Measured: 6 months
Concentration of Extracellular Vesicles Exposing Phosphatidylserine
Concentration of extracellular vesicles exposing phosphatidylserine/ml measured with flow cytometry
Measured: 6 months
Concentration of Extracellular Vesicles From Endothelial Cells
The concentrations of extracellular vesicles from endothelial cells/ ml measured with flow cytometry
Measured: 6 months
Concentration of Extracellular Vesicles From Leukocytes
Concentration of extracellular vesicles from leukocytes/ ml measured with flow cytometry
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study start30 Dec 2017
- Primary completion30 Dec 2018
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Gasecka, Medical University of Warsaw
- Investigators
- Aleksandra Gasecka, MD, Principal investigator, 1st Chair and Department of Cardiology, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931045
- Sponsor's protocol ID
- KB/112/2016
- Acronym
- AFFECT EV
- Status last verified
- Nov 2020
- First submitted
- 10 Oct 2016
- Last updated
- 23 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be presented in a collective form. If a particular study participant presents with an especially high or low concentration of the studied biomarker , the participant's characteristics may be described separately in a way which does not allow to identify the participant's personal data.
Publications
Gasecka A, Nieuwland R, van der Pol E, Hajji N, Cwiek A, Pluta K, Konwerski M, Filipiak KJ. P2Y12 antagonist ticagrelor inhibits the release of procoagulant extracellular vesicles from activated platelets. Cardiol J. 2019;26(6):782-789. doi: 10.5603/CJ.a2018.0045. Epub 2018 Apr 19.
PubMed 29671861
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiplatelet Therapy Effect on Platelet Extracellular Vesicles in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02931045
- Acronym / sponsor ID
- AFFECT EV / KB/112/2016
- Conditions
- Myocardial Infarction
- Keywords
- extracellular vesicles, inflammation, thrombosis, antiplatelet drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 30 Dec 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Posted 23 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Platelet activation and aggregation leads to myocardial infarction. Platelet P2Y12 receptors are essential for platelet activation. Antagonists against the P2Y12 receptor, which are established in secondary prevention of myocardial infarction, have unexplained anti-inflammatory effects. A novel P2Y12 receptor antagonist ticagrelor reduced infection-related mortality compared to clopidogrel, previous standard treatment for patients with myocardial infarction. Activated platelets release pro-inflammatory and procoagulant platelet extracellular vesicles. The investigators assume that decrease in infection-related mortality in patients treated with ticagrelor may be explained by greater inhibition of the release of platelet vesicles by ticagrelor, compared to clopidogrel. This study is expected to identify an additional mechanism of action of ticagrelor, which might contribute to the observed clinical benefits in patients treated with ticagrelor.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Active comparator | Drug: TicagrelorTicagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose) |
| Clopidogrel | Active comparator | Drug: ClopidogrelClopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Informed consent to participate in the study
- Percutaneous coronary intervention with stent implantation due to first S T elevation myocardial infarction, or first non S T -elevation myocardial infarction
- Administration of a loading dose of clopidogrel
Key exclusion criteria (17 listed)
- Known coagulopathy
- Known history of bleeding disorder
- Suspicion of intracranial haemorrhage
- Need for oral anticoagulation therapy
- Administration of glycoprotein (GP) II b - III a antagonists
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 antiplatelet drug (clopidogrel) | Drug | Ticagrelor |
| ClopidogrelAlso: PlavixComparison of clopidogrel with another antiplatelet drug (ticagrelor) | Drug | Clopidogrel |
Primary outcome
Concentration of Platelet Extracellular Vesicles/ml
Time frame: 6 months following the beginning of antiplatelet therapy
Concentration of platelet extracellular vesicles/ml measured with flow cytometry
4 secondary outcomes
Concentration of Extracellular Vesicles Exposing Fibrinogen
Time frame: 6 months
Concentration of Extracellular Vesicles Exposing Phosphatidylserine
Time frame: 6 months
Concentration of Extracellular Vesicles From Endothelial Cells
Time frame: 6 months
Concentration of Extracellular Vesicles From Leukocytes
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29671861Gasecka A, Nieuwland R, van der Pol E, Hajji N, Cwiek A, Pluta K, Konwerski M, Filipiak KJ. P2Y12 antagonist ticagrelor inhibits the release of procoagulant extracellular vesicles from activated platelets. Cardiol J. 2019;26(6):782-789. doi: 10.5603/CJ.a2018.0045. Epub 2018 Apr 19.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. The data will be presented in a collective form. If a particular study participant presents with an especially high or low concentration of the studied biomarker , the participant's characteristics may be described separately in a way which does not allow to identify the participant's personal data.
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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.
Aleksandra Gasecka, MD principal investigator
1st Chair and Department of Cardiology, Medical University of Warsaw
2 sites in 2 countries: 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 Myocardial Infarction, run by Medical University of Warsaw at 2 sites in 2 countries.
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 4 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: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Poland. 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?
Yes. Results are posted in the registry (first posted 23 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Concentration of Platelet Extracellular Vesicles/ml (time frame: 6 months following the beginning of antiplatelet therapy). 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 NCT02931045, 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 23 Dec 2020.