Adverse Effect of Antithrombotic DrugsPhase 1ECCLIPSENCT02243137
Study of Platelet Function After Administration of Aspirin Versus Lysine Acetylsalicylate
A Phase 1 study testing acetylsalicylic acid, prasugrel and lysine acetylsalicylate in people with Adverse Effect of Antithrombotic Drugs, run by David Vivas at 1 site in Spain.
Trial summary
This is a phase I clinical trial in healthy volunteers comparing the effect of lysine acetylsalicylate or aspirin on platelet function. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Effect of Antithrombotic Drugs
- What is being tested?
- acetylsalicylic acid, prasugrel and lysine acetylsalicylate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- May 2013to Jun 2014
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years.
- BMI> 19kg/m2 and <29kg/m2.
- Women of childbearing potential who are committed to use a medically effective contraception during their participation in the study, except hormonal contraceptives.
- Percentage of inhibition of platelet aggregation after stimulation with high basal 20 mM ADP and arachidonic acid 1.5 mM> 70%.
- No clinically significant deviation on physical examination, ECG or laboratory values in laboratory tests.
- Signed informed consent
Who cannot join
- Smoking
- Drug abuse
- Pregnant or lactating
- Infection with Hepatitis B or C, or HIV
- Known drug allergies
- Family history of blood disorders or coagulation.
Show all 12Show fewer
- History of disease that alters the absorption, metabolism or excretion of drugs, including jaundice.
- Personal history of bleeding and / or blood dyscrasias (especially hemophilia, hypoprothrombinemia), including vascular malformations reasonable suspicion.
- History of any medically relevant condition
- Background of major surgery in the last 3 months
- Prescription of chronic medication in the 14 days prior to study participation.
- Participation in another study involving the administration of an investigational product in the last 4 months or a product already on the market in the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Combinated Administration of Lysine Acetylsalicylate Versus Prasugrel and Aspirin on Platelet Aggregation in Healthy Volunteers
This is a phase I clinical trial in healthy volunteers comparing the effect of lysine acetylsalicylate or aspirin on platelet function.
Read the detailed description
- SUMMARY 1.1. Type of trial Phase I clinical trial in healthy volunteers and marketed drugs 1.2. Identification of the promoter (correspondence to) Dr. David Vivas Balcones Cardiology Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Phone: +34 91 330 31 49 Fax: +34 913303142 Email: dvivas@secardiologia.es 1.3. Clinical trial title Effect of combined administration of prasugrel and lysine acetylsalicylate intravenously versus prasugrel and aspirin on platelet aggregation in healthy volunteers (ECCLIPSE trial).
1.4. Protocol code Nº EudraCT: 2012-001702-20 Code: 2012-ECCLIPSE-01 Version: V3 Date: 13/04/2012
1.5. Project principal investigator Dr. David Vivas Balcones Cardiology Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Phone: +34 91 330 31 49 Fax: +34 913303142 Email: dvivas@secardiologia.es 1.6. Centers Investigators
San Carlos University Hospital (Madrid). Within the following services and researchers are involved:
Cardiology Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Teléfono: +34 91 330 31 49 Fax: +34 913303142 Project principal investigator and Promoter: Dr. David Vivas Balcones Co-Investigators: Dr. Agustín Martín, Dr. Isidre Vilacosta, Dr. Iván Núñez-Gil y Dr. Carlos Macaya
Platelet function laboratory Cardiology Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Phone: +34 913307260 Fax: +34 913303142 Co-Investigators: Dr. Antonio Fernández-Ortiz, Esther Bernardo y María Aranzazu Ortega Pozzi
Clinical Trials Unit (CEIC) Biomedical Research Foundation Hospital Clínico San Carlos C/ Prof. Martín Lagos S/N 28040 Madrid Phone: + 34 913303793 Fax: +34 913303515 Co-Investigator: Dra. Saioa Alonso
Clinical Research Ethics Committee The Clinical Research Ethics Committee (CEIC) charged with assessing the project will be the CEIC of the San Carlos University Hospital.
1.7. Responsible for Monitoring: MEDITRIALS 1.8. Experimental and control drug • Experimental group: Loading dose (LD) of intravenous lysine acetylsalicylate 450 mg and prasugrel 60 mg orally.
- Control group: Loading dose (LD) of aspirin 300 mg orally and prasugrel 60 mg orally. Being a crossover study, subjects will receive both treatment arms in the two treatment periods with a gap of 15 days (washout period) between the two administrations.
1.9. Study endpoints Primary endpoint To compare the inhibition of platelet aggregation (IPA) at 30 minutes after administration of prasugrel loading dose in association with intravenous lysine acetylsalicylate versus prasugrel plus aspirin.
Secundary endpoints To compare the inhibition of platelet aggregation (IPA) at 0 (baseline), 1, 4 and 24 hours after the administration of both treatment groups.
To compare the inhibition of platelet reactivity (IPR) throughout the time period in both treatment groups.
To evaluate the safety of the treatment administered.
1.10. Study design The ECCLIPSE study is a phase I, randomized, single center, open, two-period crossover trial in each of which subjects receive a single dose of certain drugs in each treatment group.
1.11. Pathology study None. 1.12. Population and sample size The study population will be healthy volunteers (total 30 subjects). This is a pharmacodynamic study, with subsequent extrapolation of findings to patients with acute coronary syndrome 1.13. Duration of treatment In each period of treatment, subjects will received a single dose of drugs determined in each treatment arm and the analysis of the parameters under study will be processed over the next 24 hours. After the two weeks washout period, subjects will receive the other study drug regimen in a single dose and it will take place the analysis within 24 hours of the parameters studied.
1.14. Primary variable Inhibition of platelet aggregation measured by light transmission aggregometry at 30 minutes.
- Conditions
- Adverse Effect of Antithrombotic Drugs
- Being tested
- acetylsalicylic acid, prasugrel, lysine acetylsalicylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicylic acidDrug
Also called Adiro
Administration: one dose of Acetylsalicylic Acid (300mg)
prasugrelDrug
Also called Effient
Administration: one loading dose (60mg)
lysine acetylsalicylateDrug
Also called Inyesprin
Administration: one dose (450mg iv)
| Study group | Role | What they receive |
|---|---|---|
| prasugrel and acetylsalicylic | Active comparator | single dose of prasugrel 60 mg orally and 300 mg acetylsalicylic acid orally Receives: Drug: acetylsalicylic acid; Drug: prasugrel |
| lysine acetylsalicylate and prasugrel | Experimental | single dose of prasugrel 60 mg oral and lysine acetylsalicylate 450 mg intravenous Receives: Drug: prasugrel; Drug: lysine acetylsalicylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition of platelet aggregation
measured by light transmission aggregometry
Measured: at 30 minutes
Secondary outcomes (3)
Inhibition of platelet aggregation
measured by light transmission aggregometry
Measured: baseline, 1 h, 4 h and 34 h
Inhibition of platelet reactivity
by the platelet reactivity index (PRI)
Measured: baseline, 1 h, 4 h and 34 h
Incidence of adverse events
Measured: baseline, 30 min, 1 h, 4 h, and 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startMay 2013
- Primary completionJun 2014
- Study completionJun 2014
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 Adverse Effect of Antithrombotic DrugsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Vivas
- Sponsor type
- University, hospital or other
- Collaborators
- St Carlos Hospital, Madrid, Spain
- Responsible party
- Sponsor-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
- NCT02243137
- Sponsor's protocol ID
- 2012-ECCLIPSE-01
- Other IDs
- 2012-001702-20
- Acronym
- ECCLIPSE
- Status last verified
- Sep 2014
- First submitted
- 24 Jun 2013
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Vivas D, Martin A, Bernardo E, Ortega-Pozzi MA, Tirado G, Fernandez C, Vilacosta I, Nunez-Gil I, Macaya C, Fernandez-Ortiz A. Impact of Intravenous Lysine Acetylsalicylate Versus Oral Aspirin on Prasugrel-Inhibited Platelets: Results of a Prospective, Randomized, Crossover Study (the ECCLIPSE Trial). Circ Cardiovasc Interv. 2015 May;8(5):e002281. doi: 10.1161/CIRCINTERVENTIONS.114.002281.
PubMed 25957056
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combinated Administration of Lysine Acetylsalicylate Versus Prasugrel and Aspirin on Platelet Aggregation in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02243137
- Acronym / sponsor ID
- ECCLIPSE / 2012-ECCLIPSE-01
- Conditions
- Adverse Effect of Antithrombotic Drugs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- David VivasUniversity, hospital or other
- Collaborators
- St Carlos Hospital, Madrid, Spain
- Study start
- May 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Sep 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.
This is a phase I clinical trial in healthy volunteers comparing the effect of lysine acetylsalicylate or aspirin on platelet function.
Detailed description
- SUMMARY 1.1. Type of trial Phase I clinical trial in healthy volunteers and marketed drugs 1.2. Identification of the promoter (correspondence to) Dr. David Vivas Balcones Cardiology Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Phone: +34 91 330 31 49 Fax: +34 913303142 Email: dvivas@secardiologia.es 1.3. Clinical trial title Effect of combined administration of prasugrel and lysine acetylsalicylate intravenously versus prasugrel and aspirin on platelet aggregation in healthy volunteers (ECCLIPSE trial).
1.4. Protocol code Nº EudraCT: 2012-001702-20 Code: 2012-ECCLIPSE-01 Version: V3 Date: 13/04/2012
1.5. Project principal investigator Dr. David Vivas Balcones Cardiology Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Phone: +34 91 330 31 49 Fax: +34 913303142 Email: dvivas@secardiologia.es 1.6. Centers Investigators
San Carlos University Hospital (Madrid). Within the following services and researchers are involved:
Cardiology Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Teléfono: +34 91 330 31 49 Fax: +34 913303142 Project principal investigator and Promoter: Dr. David Vivas Balcones Co-Investigators: Dr. Agustín Martín, Dr. Isidre Vilacosta, Dr. Iván Núñez-Gil y Dr. Carlos Macaya
Platelet function laboratory Cardiology Department Hospital Clínico San Carlos C/Prof Martín Lagos SN 28040 Madrid Phone: +34 913307260 Fax: +34 913303142 Co-Investigators: Dr. Antonio Fernández-Ortiz, Esther Bernardo y María Aranzazu Ortega Pozzi
Clinical Trials Unit (CEIC) Biomedical Research Foundation Hospital Clínico San Carlos C/ Prof. Martín Lagos S/N 28040 Madrid Phone: + 34 913303793 Fax: +34 913303515 Co-Investigator: Dra. Saioa Alonso
Clinical Research Ethics Committee The Clinical Research Ethics Committee (CEIC) charged with assessing the project will be the CEIC of the San Carlos University Hospital.
1.7. Responsible for Monitoring: MEDITRIALS 1.8. Experimental and control drug • Experimental group: Loading dose (LD) of intravenous lysine acetylsalicylate 450 mg and prasugrel 60 mg orally.
- Control group: Loading dose (LD) of aspirin 300 mg orally and prasugrel 60 mg orally. Being a crossover study, subjects will receive both treatment arms in the two treatment periods with a gap of 15 days (washout period) between the two administrations.
1.9. Study endpoints Primary endpoint To compare the inhibition of platelet aggregation (IPA) at 30 minutes after administration of prasugrel loading dose in association with intravenous lysine acetylsalicylate versus prasugrel plus aspirin.
Secundary endpoints To compare the inhibition of platelet aggregation (IPA) at 0 (baseline), 1, 4 and 24 hours after the administration of both treatment groups.
To compare the inhibition of platelet reactivity (IPR) throughout the time period in both treatment groups.
To evaluate the safety of the treatment administered.
1.10. Study design The ECCLIPSE study is a phase I, randomized, single center, open, two-period crossover trial in each of which subjects receive a single dose of certain drugs in each treatment group.
1.11. Pathology study None. 1.12. Population and sample size The study population will be healthy volunteers (total 30 subjects). This is a pharmacodynamic study, with subsequent extrapolation of findings to patients with acute coronary syndrome 1.13. Duration of treatment In each period of treatment, subjects will received a single dose of drugs determined in each treatment arm and the analysis of the parameters under study will be processed over the next 24 hours. After the two weeks washout period, subjects will receive the other study drug regimen in a single dose and it will take place the analysis within 24 hours of the parameters studied.
1.14. Primary variable Inhibition of platelet aggregation measured by light transmission aggregometry at 30 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prasugrel and acetylsalicylic | Active comparator | Drug: acetylsalicylic acid, Drug: prasugrelsingle dose of prasugrel 60 mg orally and 300 mg acetylsalicylic acid orally |
| lysine acetylsalicylate and prasugrel | Experimental | Drug: prasugrel, Drug: lysine acetylsalicylatesingle dose of prasugrel 60 mg oral and lysine acetylsalicylate 450 mg intravenous |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-60 years.
- BMI> 19kg/m2 and <29kg/m2.
- Women of childbearing potential who are committed to use a medically effective contraception during their participation in the study, except hormonal contraceptives.
- Percentage of inhibition of platelet aggregation after stimulation with high basal 20 mM ADP and arachidonic acid 1.5 mM> 70%.
- No clinically significant deviation on physical examination, ECG or laboratory values in laboratory tests.
Key exclusion criteria (12 listed)
- Smoking
- Drug abuse
- Pregnant or lactating
- Infection with Hepatitis B or C, or HIV
- Known drug allergies
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 |
|---|---|---|
| acetylsalicylic acidAlso: AdiroAdministration: one dose of Acetylsalicylic Acid (300mg) | Drug | prasugrel and acetylsalicylic |
| prasugrelAlso: EffientAdministration: one loading dose (60mg) | Drug | lysine acetylsalicylate and prasugrel, prasugrel and acetylsalicylic |
| lysine acetylsalicylateAlso: InyesprinAdministration: one dose (450mg iv) | Drug | lysine acetylsalicylate and prasugrel |
Primary outcome
Inhibition of platelet aggregation
Time frame: at 30 minutes
measured by light transmission aggregometry
3 secondary outcomes
Inhibition of platelet aggregation
Time frame: baseline, 1 h, 4 h and 34 h
Inhibition of platelet reactivity
Time frame: baseline, 1 h, 4 h and 34 h
Incidence of adverse events
Time frame: baseline, 30 min, 1 h, 4 h, and 24 h
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 17 Sep 2014.
- Derived from this study: PubMed 25957056Vivas D, Martin A, Bernardo E, Ortega-Pozzi MA, Tirado G, Fernandez C, Vilacosta I, Nunez-Gil I, Macaya C, Fernandez-Ortiz A. Impact of Intravenous Lysine Acetylsalicylate Versus Oral Aspirin on Prasugrel-Inhibited Platelets: Results of a Prospective, Randomized, Crossover Study (the ECCLIPSE Trial). Circ Cardiovasc Interv. 2015 May;8(5):e002281. doi: 10.1161/CIRCINTERVENTIONS.114.002281.
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 1 study testing acetylsalicylic acid, prasugrel and lysine acetylsalicylate in people with Adverse Effect of Antithrombotic Drugs, run by David Vivas 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 6 inclusion and 12 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 17 Sep 2014. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Inhibition of platelet aggregation (time frame: at 30 minutes). 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 NCT02243137, 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 17 Sep 2014.