Coronary Artery DiseasePhase 3NCT01805596
Effect of Ticagrelor on Endothelial Function
A Phase 3 study testing clopidogrel and Ticagrelor in people with Coronary Artery Disease and Endothelial Function, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This study is to assess the function of blood vessels while being treated with different types of blood thinners to determine the effect of these medications on blood vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Endothelial Function
- What is being tested?
- clopidogrel and Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Jul 2016
- Phase
- Phase 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
- Age>18 years old
- At least two cardiovascular risk factors
- Demonstrated endothelial dysfunction
- Evidence of coronary artery disease
Who cannot join
- Second (II) or third (III) degree heart block without a pacemaker
- Known active pathological bleeding, history of stroke, or bleeding diathesis
- Dyspnea classified as NYHA class III-IV
- Need for oral anticoagulants
- Clinically significant valvular heart disease
- Any concurrent life threatening condition with a life expectancy less than 1 year
Show all 15Show fewer
- History or evidence of drug or alcohol abuse within the last 12 months
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
- History of hypersensitivity to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs.
- Latex allergy
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer Positive pregnancy test, breast feeding women or women of child bearing potential not using highly effective methods of contraception.
- Patients who are also taking strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir)
- patients taking antiplatelet medications which cannot be stopped
- severe liver disease
Trial locations and contacts
1 site in 1 country.
About this study
This study is to assess the function of blood vessels while being treated with different types of blood thinners to determine the effect of these medications on blood vessels.
- Conditions
- Coronary Artery Disease, Endothelial Function
- Being tested
- clopidogrel, Ticagrelor
- Keywords
- coronary artery disease, endothelial function, antiplatelet agent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
Also called Plavix
TicagrelorDrug
Also called Brilinta
| Study group | Role | What they receive |
|---|---|---|
| clopidogrel-ticagrelor | Experimental | 21 days clopidogrel followed by 21 days ticagrelor Receives: Drug: clopidogrel; Drug: Ticagrelor |
| ticagrelor-clopidogrel | Experimental | ticagrelor for 21 days followed by clopidogrel for 21 days Receives: Drug: clopidogrel; Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Endothelial Function after 21 days of antiplatelet medication
The change in endothelial function from baseline will be assessed after 21 days of clopidogrel; the change in endothelial function from baseline will be assessed after 21 days of ticagrelor. This will be measured using RH-PAT units.
Measured: 21 days
Secondary outcomes (1)
Acute change in endothelial function
Endothelial function assessed 2 hours post ticagrelor
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2016
- Study completionJul 2016
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 Coronary Artery DiseaseStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahar Lavi, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Shahar Lavi, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805596
- Sponsor's protocol ID
- ENTC-18129
- Status last verified
- Oct 2016
- First submitted
- 1 Mar 2013
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Alemayehu M, Kim RB, Lavi R, Gong I, D'Alfonso S, Mansell SE, Wall S, Lavi S. Effect of Ticagrelor Versus Clopidogrel on Vascular Reactivity. J Am Coll Cardiol. 2017 May 2;69(17):2246-2248. doi: 10.1016/j.jacc.2017.02.048. No abstract available.
PubMed 28449783
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ticagrelor on Endothelial Function
- ClinicalTrials.gov ID
- NCT01805596
- Acronym / sponsor ID
- ENTC-18129
- Conditions
- Coronary Artery Disease, Endothelial Function
- Keywords
- coronary artery disease, endothelial function, antiplatelet agent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 6 Mar 2013 (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 study is to assess the function of blood vessels while being treated with different types of blood thinners to determine the effect of these medications on blood vessels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clopidogrel-ticagrelor | Experimental | Drug: clopidogrel, Drug: Ticagrelor21 days clopidogrel followed by 21 days ticagrelor |
| ticagrelor-clopidogrel | Experimental | Drug: clopidogrel, Drug: Ticagrelorticagrelor for 21 days followed by clopidogrel for 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>18 years old
- At least two cardiovascular risk factors
- Demonstrated endothelial dysfunction
- Evidence of coronary artery disease
Key exclusion criteria (15 listed)
- Second (II) or third (III) degree heart block without a pacemaker
- Known active pathological bleeding, history of stroke, or bleeding diathesis
- Dyspnea classified as NYHA class III-IV
- Need for oral anticoagulants
- Clinically significant valvular heart disease
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 |
|---|---|---|
| clopidogrelAlso: Plavix | Drug | clopidogrel-ticagrelor, ticagrelor-clopidogrel |
| TicagrelorAlso: Brilinta | Drug | clopidogrel-ticagrelor, ticagrelor-clopidogrel |
Primary outcome
Change from Baseline in Endothelial Function after 21 days of antiplatelet medication
Time frame: 21 days
The change in endothelial function from baseline will be assessed after 21 days of clopidogrel; the change in endothelial function from baseline will be assessed after 21 days of ticagrelor. This will be measured using RH-PAT units.
1 secondary outcome
Acute change in endothelial function
Time frame: 2 hours
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 5 Oct 2016.
- Derived from this study: PubMed 28449783Alemayehu M, Kim RB, Lavi R, Gong I, D'Alfonso S, Mansell SE, Wall S, Lavi S. Effect of Ticagrelor Versus Clopidogrel on Vascular Reactivity. J Am Coll Cardiol. 2017 May 2;69(17):2246-2248. doi: 10.1016/j.jacc.2017.02.048. No abstract available.
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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.
Shahar Lavi, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clopidogrel and Ticagrelor in people with Coronary Artery Disease and Endothelial Function, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 15 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 5 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 Canada. 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 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?
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?
Change from Baseline in Endothelial Function after 21 days of antiplatelet medication (time frame: 21 days). 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 NCT01805596, 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 5 Oct 2016.