Acute Coronary Syndrome (ACS)NCT02244710
EndoTic - Endothelium and Ticagrelor
A study testing Ticagrelor vs Clopidogrel in people with Acute Coronary Syndrome (ACS), run by Fundación Investigación Sanitaria en León at 3 sites in Spain.
Trial summary
Randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial Progenitor Cells) in patients with ACS (Acute Coronary Syndrome), from baseline levels to chronic levels (1 month). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome (ACS)
- What is being tested?
- Ticagrelor vs Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 3 sitesSpain
- Study dates
- Mar 2015to Sep 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to sign Informed Consent Form
- 18 yr or older
- Male and female (post menopause or contraception treatment)
- ACS diagnosed with elevation of myocardial infarction biomarkers (as of 3rd Universal Definition of MI)
- Planned invasive strategy (coronariography performed within 72hrs after admission)
Who cannot join
- Aspirin, clopidogrel or ticagrelor allergy.
- Hemorrhagic diathesis or very high risk of bleeding.
- Current treatment with oral anticoagulants, thienopyridines or ticagrelor.
- Limited life expectancy.
- Elective surgery planned.
- High chance of not being able to complete the follow-up period.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital de Leon
León, Leon, 24008
Hospital Universitario de Salamanca
Salamanca
Hospital Universitario de Santiago
Santiago de Compostela, La Coruña
About this study
Official title: EndoTic - Endothelium and Ticagrelor: Pharmacological Effects Beyond Antiplatelet Therapy
Randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial Progenitor Cells) in patients with ACS (Acute Coronary Syndrome), from baseline levels to chronic levels (1 month).
Read the detailed description
ACS Patients in both treatment groups will be assessed:
Baseline, 48h and 1 month cell counts will be done for CECs and EPCs Platelet Function at 48h and 1month Adverse Events, ECG and blood testing result will be also collected
- Conditions
- Acute Coronary Syndrome (ACS)
- Being tested
- Ticagrelor vs Clopidogrel
- Keywords
- Circulating Endothelial Cells, Endothelial Progenitor Cells, Acute coronary syndrome (ACS), Ticagrelor
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor vs ClopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | 180mg initial dose next day 90mg BID Receives: Drug: Ticagrelor vs Clopidogrel |
| Clopidogrel | Active comparator | 600mg po initial dose and 75mg qd starting next day Receives: Drug: Ticagrelor vs Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cells
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
Measured: Baseline
Number of cells
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
Measured: 48 hours after last chest pain episode
Number of cells
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
Measured: 1 month visit
Secondary outcomes (2)
Platelet reactivity
As determined by P2Y12 kits, VerifyNow®
Measured: At the time of coronary angiography
Platelet reactivity
As determined by P2Y12 kits, VerifyNow®
Measured: 1 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome (ACS)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Investigación Sanitaria en León
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Armando Pérez de Prado, MD, PhD, Principal investigator, Fundación Investigación Sanitaria en LeónM. Belen Vidriales Acosta, MD, PhD, Study director, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244710
- Sponsor's protocol ID
- ISSBRIL0205
- Other IDs
- 2013-005042-11
- Status last verified
- Nov 2016
- First submitted
- 11 Sep 2014
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EndoTic - Endothelium and Ticagrelor: Pharmacological Effects Beyond Antiplatelet Therapy
- ClinicalTrials.gov ID
- NCT02244710
- Acronym / sponsor ID
- ISSBRIL0205
- Conditions
- Acute Coronary Syndrome (ACS)
- Keywords
- Circulating Endothelial Cells, Endothelial Progenitor Cells, Acute coronary syndrome (ACS), Ticagrelor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Fundación Investigación Sanitaria en LeónUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 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.
Randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial Progenitor Cells) in patients with ACS (Acute Coronary Syndrome), from baseline levels to chronic levels (1 month).
Detailed description
ACS Patients in both treatment groups will be assessed:
Baseline, 48h and 1 month cell counts will be done for CECs and EPCs Platelet Function at 48h and 1month Adverse Events, ECG and blood testing result will be also collected
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: Ticagrelor vs Clopidogrel180mg initial dose next day 90mg BID |
| Clopidogrel | Active comparator | Drug: Ticagrelor vs Clopidogrel600mg po initial dose and 75mg qd starting next day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing to sign Informed Consent Form
- 18 yr or older
- Male and female (post menopause or contraception treatment)
- ACS diagnosed with elevation of myocardial infarction biomarkers (as of 3rd Universal Definition of MI)
- Planned invasive strategy (coronariography performed within 72hrs after admission)
Key exclusion criteria (6 listed)
- Aspirin, clopidogrel or ticagrelor allergy.
- Hemorrhagic diathesis or very high risk of bleeding.
- Current treatment with oral anticoagulants, thienopyridines or ticagrelor.
- Limited life expectancy.
- Elective surgery planned.
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 |
|---|---|---|
| Ticagrelor vs Clopidogrel | Drug | Clopidogrel, Ticagrelor |
Primary outcome
Number of cells
Time frame: Baseline
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
Number of cells
Time frame: 48 hours after last chest pain episode
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
Number of cells
Time frame: 1 month visit
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
2 secondary outcomes
Platelet reactivity
Time frame: At the time of coronary angiography
Platelet reactivity
Time frame: 1 month visit
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 23 Nov 2016.
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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.
Armando Pérez de Prado, MD, PhD principal investigator
Fundación Investigación Sanitaria en León
M. Belen Vidriales Acosta, MD, PhD study director
University of Salamanca
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ticagrelor vs Clopidogrel in people with Acute Coronary Syndrome (ACS), run by Fundación Investigación Sanitaria en León at 3 sites 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 5 inclusion and 6 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Number of cells (time frame: Baseline). The study lists 3 primary outcomes in all. 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 23 Nov 2016.