Acute Myocardial InfarctionPhase 2/3ECCLIPSE-STEMINCT02929888
Study of Platelet Function After Administration of Aspirin Versus Lysine Acetylsalicylate in STEMI Patients
A Phase 2/3 study testing Lysine Acetilsalicilate and Aspirin in people with Acute Myocardial Infarction, run by Fundacion Investigacion Interhospitalaria Cardiovascular at 1 site in Spain.
Trial summary
Prasugrel and ticagrelor, new P2Y12-ADP receptor antagonists, are associated with greater pharmacodynamic inhibition and reduction of cardiovascular events in patients with an acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Lysine Acetilsalicilate and Aspirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2016to Jul 2017
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged > 18.
- Patients with ST-segment myocardial infarction.
- Signed written informed consent.
Who cannot join
- Known allergies to aspirin, clopidogrel, prasugrel or ticagrelor.
- Cardiogenic shock or hemodinamic instability.
- Recent antiplatelet therapy (<14 days).
- Oral anticoagulation with a coumarin derivative.
- Any active bleeding or blood dyscrasia.
- Recent gastrointestinal bleeding (<6 months prior to inclusion).
Show all 10Show fewer
- Recent history of stroke, TIA or intracranial bleeding (<6 months prior to inclusion).
- Known anemia, trombopenia or severe chronic kidney/liver disease
- Any known active neoplasm.
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fundacion
Madrid, Madrid, 28040
David Vivas, MD, PhD, 0034913303149 ext. 3149, dvivas@secardiologia.es
About this study
Official title: Effects of Intravenous Lysine Acetylsalicylate Versus Oral Aspirin on Platelet Responsiveness in Patients With ST-segment Elevation Myocardial Infarction: a Pharmacodynamic Study (ECCLIPSE-STEMI Trial)
Prasugrel and ticagrelor, new P2Y12-ADP receptor antagonists, are associated with greater pharmacodynamic inhibition and reduction of cardiovascular events in patients with an acute coronary syndrome. However, evidence is lacked about the effects of achieving faster and stronger cyclooxygenase inhibition with intravenous lysine acetylsalicylate (LA) compared to oral aspirin on prasugrel inhibited platelets. Recently, we demonstrated in healthy volunteers that the administration of intravenous LA resulted in a significantly reduction of platelet reactivity compared to oral aspirin on prasugrel inhibited platelets. Loading dose of LA achieves platelet inhibition faster, greater and with less variability than aspirin. However, there are no data of this issue in patients with an ST-segment elevation myocardial infarction (STEMI). The ECCLIPSE-STEMI trial will study the effect of LA versus aspirin in platelet reactivity in patients with STEMI
Read the detailed description
This is a prospective, randomized, single-center, open platelet function study conducted in 60 STEMI patients. Subjects were randomly assigned to receive a loading dose (LD) of intravenous LA 450mg plus oral prasugrel 60mg/ticagrelor 180mg, or LD of aspirin 300mg plus prasugrel 60mg/ticagrelor 180mg orally. Platelet function was evaluated at baseline, 30 min, 1h, 4h, and 24h using multiple electrode aggregometry and vasodilator-stimulated phosphoprotein phosphorylation (VASP). The primary endpoint of the study is the inhibition of platelet aggregation after arachidonic acid (AA) 1.5mM at 30 min. Secondary endopoints are the inhibition of platelet aggregation after AA baseline and at 1h, 4h and 24h, and measurement of aggregation with other platelet test (ADP, collagen and VASP).
- Conditions
- Acute Myocardial Infarction
- Being tested
- Lysine Acetilsalicilate, Aspirin
- Keywords
- ST-segment elevacion myocardial infarction, platelets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lysine AcetilsalicilateDrug
AspirinDrug
| Study group | Role | What they receive |
|---|---|---|
| Lysine Acetilsalicilate (LA) | Experimental | Loading dose (LD) of intravenous LA 450mg plus oral prasugrel 60mg/ticagrelor 180mg in patients with ST-segment elevation myocardial infarction Receives: Drug: Lysine Acetilsalicilate |
| Aspirin | Active comparator | Loading dose (LD) of oral aspirin 300mg plus oral prasugrel 60mg/ticagrelor 180mg in patients with ST-segment elevation myocardial infarction Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition of platelet aggregation
The primary endpoint of the study, inhibition of platelet aggregation after arachidonic acid (AA) 1.5mM at 30 min
Measured: 30 min
Secondary outcomes (1)
Inhibition of platelet aggregation
Inhibition of platelet aggregation using different platelet function test (ADP, collagen, VASP)
Measured: 30 min, 1h, 4h, 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2017 (estimated)
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 Acute 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Investigacion Interhospitalaria Cardiovascular
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Vivas, Fundacion Investigacion Interhospitalaria Cardiovascular
- Investigators
- David Vivas, MD, PhD, Principal investigator, San Carlos University Hospital, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929888
- Sponsor's protocol ID
- 2016-ECCLIPSESTEMI-01
- Acronym
- ECCLIPSE-STEMI
- Status last verified
- Oct 2016
- First submitted
- 8 Oct 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
Publications
Vivas D, Jimenez JJ, Martin-Asenjo R, Bernardo E, Ortega-Pozzi MA, Gomez-Polo JC, Moreno G, Vilacosta I, Perez-Villacastin J, Fernandez-Ortiz A. Effects of intravenous lysine acetylsalicylate versus oral aspirin on platelet responsiveness in patients with ST-segment elevation myocardial infarction: the ECCLIPSE-STEMI trial. J Thromb Thrombolysis. 2023 Feb;55(2):203-210. doi: 10.1007/s11239-022-02737-y. Epub 2022 Dec 8.
PubMed 36480147
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Lysine Acetylsalicylate Versus Oral Aspirin on Platelet Responsiveness in Patients With ST-segment Elevation Myocardial Infarction: a Pharmacodynamic Study (ECCLIPSE-STEMI Trial)
- ClinicalTrials.gov ID
- NCT02929888
- Acronym / sponsor ID
- ECCLIPSE-STEMI / 2016-ECCLIPSESTEMI-01
- Conditions
- Acute Myocardial Infarction
- Keywords
- ST-segment elevacion myocardial infarction, platelets
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundacion Investigacion Interhospitalaria CardiovascularUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jul 2017 (estimated)
- First posted
- 11 Oct 2016 (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.
Prasugrel and ticagrelor, new P2Y12-ADP receptor antagonists, are associated with greater pharmacodynamic inhibition and reduction of cardiovascular events in patients with an acute coronary syndrome. However, evidence is lacked about the effects of achieving faster and stronger cyclooxygenase inhibition with intravenous lysine acetylsalicylate (LA) compared to oral aspirin on prasugrel inhibited platelets. Recently, we demonstrated in healthy volunteers that the administration of intravenous LA resulted in a significantly reduction of platelet reactivity compared to oral aspirin on prasugrel inhibited platelets. Loading dose of LA achieves platelet inhibition faster, greater and with less variability than aspirin. However, there are no data of this issue in patients with an ST-segment elevation myocardial infarction (STEMI). The ECCLIPSE-STEMI trial will study the effect of LA versus aspirin in platelet reactivity in patients with STEMI
Detailed description
This is a prospective, randomized, single-center, open platelet function study conducted in 60 STEMI patients. Subjects were randomly assigned to receive a loading dose (LD) of intravenous LA 450mg plus oral prasugrel 60mg/ticagrelor 180mg, or LD of aspirin 300mg plus prasugrel 60mg/ticagrelor 180mg orally. Platelet function was evaluated at baseline, 30 min, 1h, 4h, and 24h using multiple electrode aggregometry and vasodilator-stimulated phosphoprotein phosphorylation (VASP). The primary endpoint of the study is the inhibition of platelet aggregation after arachidonic acid (AA) 1.5mM at 30 min. Secondary endopoints are the inhibition of platelet aggregation after AA baseline and at 1h, 4h and 24h, and measurement of aggregation with other platelet test (ADP, collagen and VASP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lysine Acetilsalicilate (LA) | Experimental | Drug: Lysine AcetilsalicilateLoading dose (LD) of intravenous LA 450mg plus oral prasugrel 60mg/ticagrelor 180mg in patients with ST-segment elevation myocardial infarction |
| Aspirin | Active comparator | Drug: AspirinLoading dose (LD) of oral aspirin 300mg plus oral prasugrel 60mg/ticagrelor 180mg in patients with ST-segment elevation myocardial infarction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged > 18.
- Patients with ST-segment myocardial infarction.
- Signed written informed consent.
Key exclusion criteria (10 listed)
- Known allergies to aspirin, clopidogrel, prasugrel or ticagrelor.
- Cardiogenic shock or hemodinamic instability.
- Recent antiplatelet therapy (<14 days).
- Oral anticoagulation with a coumarin derivative.
- Any active bleeding or blood dyscrasia.
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 |
|---|---|---|
| Lysine Acetilsalicilate | Drug | Lysine Acetilsalicilate (LA) |
| Aspirin | Drug | Aspirin |
Primary outcome
Inhibition of platelet aggregation
Time frame: 30 min
The primary endpoint of the study, inhibition of platelet aggregation after arachidonic acid (AA) 1.5mM at 30 min
1 secondary outcome
Inhibition of platelet aggregation
Time frame: 30 min, 1h, 4h, 24h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Derived from this study: PubMed 36480147Vivas D, Jimenez JJ, Martin-Asenjo R, Bernardo E, Ortega-Pozzi MA, Gomez-Polo JC, Moreno G, Vilacosta I, Perez-Villacastin J, Fernandez-Ortiz A. Effects of intravenous lysine acetylsalicylate versus oral aspirin on platelet responsiveness in patients with ST-segment elevation myocardial infarction: the ECCLIPSE-STEMI trial. J Thromb Thrombolysis. 2023 Feb;55(2):203-210. doi: 10.1007/s11239-022-02737-y. Epub 2022 Dec 8.
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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.
David Vivas, MD, PhD principal investigator
San Carlos University Hospital, Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lysine Acetilsalicilate and Aspirin in people with Acute Myocardial Infarction, run by Fundacion Investigacion Interhospitalaria Cardiovascular at 1 site in Spain.
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: status not confirmed, as of the sponsor's last update on 11 Oct 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 Spain. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Vivas, MD, PhD (0034 913303149 ext. 3149, dvivas@secardiologia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibition of platelet aggregation (time frame: 30 min). 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 NCT02929888, 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 11 Oct 2016.