Coronary Artery DiseasePhase 2/3PATHNCT01894789
Ticagrelor vs Clopidogrel Effect on MFR in CAD Population
A Phase 2/3 study testing Ticagrelor and Clopidogrel in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
Ticagrelor is one of 3 anti-platelet medications used in patients with acute coronary syndrome (ACS) to prevent further clot formation and further ischemic damage to myocardial tissue. Overall benefits of one drug over the other is neutral in this generally unstable population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- 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
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Mar 2015
- 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
- Age ≥ 18 years old
- Stable coronary artery disease on stable medical treatment.
- BMI equal to or less than 30 kg/m2
- No clinically significant abnormalities in baseline laboratory work
- No clinically significant arrhythmias on baseline 12-lead electrocardiogram
- Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening and maintain effective contraceptive methods throughout the trial and for 7 days following the end of dosing treatment.
Who cannot join
- Any contraindication against the use of clopidogrel, ticagrelor and/or ASA.
- Oral anticoagulation therapy.
- History of intracranial bleeding.
- Recent or active pathological bleeding, such as peptic ulcer.
- Moderate or severe hepatic impairment.
- History or risk of bradycardia.
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- Known second- or third-degree AV block without pacemaker
- Dyspnea (NYHA III/IV), wheezing asthma or COPD.
- Coronary artery bypass graft (CABG) surgery within 90 days prior to screening or at any time after consent.
- Percutaneous coronary intervention (PCI) within 90 days prior to screening or at any time following consent.
- Acute myocardial infarction or acute coronary syndrome within 60 days prior to screening or at any time following consent.
- Any scheduled surgery during the trial period, including dental.
- Concomitant therapy with strong cytochrome CYP 3A inhibitor or inducer.
- Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
- Known hypersensitivity to the investigational drug or any of its components.
- Known hypersensitivity to adenosine.
- Lactose intolerance
- Breastfeeding or pregnancy.
- Claustrophobia or inability to lie still in a supine position
- Unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ComPArison of the Effect of Ticagrelor Versus Clopidogrel on Myocardial Blood Flow (MBF) and Reserve (MBFR) Measured With Positron Emission TomograpHy (PET) in Patients With Coronary Artery Disease (CAD): The PATH Study
Ticagrelor is one of 3 anti-platelet medications used in patients with acute coronary syndrome (ACS) to prevent further clot formation and further ischemic damage to myocardial tissue. Overall benefits of one drug over the other is neutral in this generally unstable population. In pre-clinical trials, ticagrelor showed secondary effects, involving the release of adenosine to heart muscle where the demand for blood was increased due to a stress condition. Blood flow was increased, potentially preventing potential damage.
This study will compare ticagrelor, currently only approved for use in ACS patients, against clopidogrel by measuring the myocardial blood flow(MBF) during stress to validate this phenomenon. The effect on blood flow will be measurable by using two specific doses of adenosine as the pharmacologic stress and correlating with measurements of blood flow using positron emission tomography (PET) nuclear imaging.
This study hypothesizes that the increase in MBF during intermediate dose adenosine infusion will be greater in ticagrelor treated subjects compared to clopidogrel treated subjects
- Conditions
- Coronary Artery Disease
- Being tested
- Ticagrelor, Clopidogrel
- Keywords
- myocardial blood flow, myocardial perfusion imaging, myocardial blood flow reserve, positron emission tomography, adenosine, ticagrelor, clopidogrel
- 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.
TicagrelorDrug
Also called BrilintaTM
Blinded administration of ticagrelor for 10 days
ClopidogrelDrug
Blinded administration of clopidogrel and placebo for 10 days
| Study group | Role | What they receive |
|---|---|---|
| stable CAD management | Experimental | Experimental: Ticagrelor (BrilintaTM) 90 mg tablet by mouth twice a day Receives: Drug: Ticagrelor; Drug: Clopidogrel |
| CAD comparison group | Active comparator | Active comparator: clopidogrel 75 mg plus placebo tablet by mouth twice a day. Receives: Drug: Ticagrelor; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in rest MBF, stress MBF and MBFR between ticagrelor and clopidogrel treated patients as measured by PET
Blinded study drug will be administered for 10 days after which the subject will undergo MPI imaging to measure MBF. The crossover to the other study arm will occur and the study procedure repeated.
Actual study drug effect will not be known until the study has completed and the treatment unblinded.
Measured: q 2 weeks blood flow measurements
Secondary outcomes (1)
The effect of ticagrelor on rest MBF, stress MBF and MBFR will be compared in the normal versus abnormal segments on a segmental and patient basis in the ticagrelor treated subjects
Blinded study drug will be administered for 10 days after which the subject will undergo MPI imaging to measure rest/stress MBF and myocardial blood flow reserve. The crossover to the other study arm will occur and the study procedure repeated.
Actual study drug effecting flow will not be known until the study has completed and the treatment unblinded.
Measured: q 2 weeks blood flow measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionMar 2015
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terrence Ruddy, Ottawa Heart Institute Research Corporation
- Investigators
- Terrence Ruddy, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894789
- Sponsor's protocol ID
- 20130105-01H
- Acronym
- PATH
- Status last verified
- Apr 2017
- First submitted
- 27 Feb 2013
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pelletier-Galarneau M, Hunter CRRN, Ascah KJ, Beanlands RSB, Dwivedi G, deKemp RA, Chow BJW, Ruddy TD. Randomized Trial Comparing the Effects of Ticagrelor Versus Clopidogrel on Myocardial Perfusion in Patients With Coronary Artery Disease. J Am Heart Assoc. 2017 May 2;6(5):e005894. doi: 10.1161/JAHA.117.005894.
PubMed 28465300
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ComPArison of the Effect of Ticagrelor Versus Clopidogrel on Myocardial Blood Flow (MBF) and Reserve (MBFR) Measured With Positron Emission TomograpHy (PET) in Patients With Coronary Artery Disease (CAD): The PATH Study
- ClinicalTrials.gov ID
- NCT01894789
- Acronym / sponsor ID
- PATH / 20130105-01H
- Conditions
- Coronary Artery Disease
- Keywords
- myocardial blood flow, myocardial perfusion imaging, myocardial blood flow reserve, positron emission tomography, adenosine, ticagrelor, clopidogrel
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Jul 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.
Ticagrelor is one of 3 anti-platelet medications used in patients with acute coronary syndrome (ACS) to prevent further clot formation and further ischemic damage to myocardial tissue. Overall benefits of one drug over the other is neutral in this generally unstable population. In pre-clinical trials, ticagrelor showed secondary effects, involving the release of adenosine to heart muscle where the demand for blood was increased due to a stress condition. Blood flow was increased, potentially preventing potential damage.
This study will compare ticagrelor, currently only approved for use in ACS patients, against clopidogrel by measuring the myocardial blood flow(MBF) during stress to validate this phenomenon. The effect on blood flow will be measurable by using two specific doses of adenosine as the pharmacologic stress and correlating with measurements of blood flow using positron emission tomography (PET) nuclear imaging.
This study hypothesizes that the increase in MBF during intermediate dose adenosine infusion will be greater in ticagrelor treated subjects compared to clopidogrel treated subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stable CAD management | Experimental | Drug: Ticagrelor, Drug: ClopidogrelExperimental: Ticagrelor (BrilintaTM) 90 mg tablet by mouth twice a day |
| CAD comparison group | Active comparator | Drug: Ticagrelor, Drug: ClopidogrelActive comparator: clopidogrel 75 mg plus placebo tablet by mouth twice a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old
- Stable coronary artery disease on stable medical treatment.
- BMI equal to or less than 30 kg/m2
- No clinically significant abnormalities in baseline laboratory work
- No clinically significant arrhythmias on baseline 12-lead electrocardiogram
Key exclusion criteria (20 listed)
- Any contraindication against the use of clopidogrel, ticagrelor and/or ASA.
- Oral anticoagulation therapy.
- History of intracranial bleeding.
- Recent or active pathological bleeding, such as peptic ulcer.
- Moderate or severe hepatic impairment.
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: BrilintaTMBlinded administration of ticagrelor for 10 days | Drug | CAD comparison group, stable CAD management |
| ClopidogrelBlinded administration of clopidogrel and placebo for 10 days | Drug | CAD comparison group, stable CAD management |
Primary outcome
Differences in rest MBF, stress MBF and MBFR between ticagrelor and clopidogrel treated patients as measured by PET
Time frame: q 2 weeks blood flow measurements
Blinded study drug will be administered for 10 days after which the subject will undergo MPI imaging to measure MBF. The crossover to the other study arm will occur and the study procedure repeated. Actual study drug effect will not be known until the study has completed and the treatment unblinded.
1 secondary outcome
The effect of ticagrelor on rest MBF, stress MBF and MBFR will be compared in the normal versus abnormal segments on a segmental and patient basis in the ticagrelor treated subjects
Time frame: q 2 weeks blood flow measurements
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 24 Apr 2017.
- Derived from this study: PubMed 28465300Pelletier-Galarneau M, Hunter CRRN, Ascah KJ, Beanlands RSB, Dwivedi G, deKemp RA, Chow BJW, Ruddy TD. Randomized Trial Comparing the Effects of Ticagrelor Versus Clopidogrel on Myocardial Perfusion in Patients With Coronary Artery Disease. J Am Heart Assoc. 2017 May 2;6(5):e005894. doi: 10.1161/JAHA.117.005894.
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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.
Terrence Ruddy, MD principal investigator
Ottawa Heart Institute Research Corporation
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 Ticagrelor and Clopidogrel in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation 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 6 inclusion and 20 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 24 Apr 2017. 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 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?
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?
Differences in rest MBF, stress MBF and MBFR between ticagrelor and clopidogrel treated patients as measured by PET (time frame: q 2 weeks blood flow measurements). 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 NCT01894789, 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 24 Apr 2017.