Plaque, AtheroscleroticPhase 4NCT01905566
Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation
A Phase 4 study testing Clopidogrel and Ticagrelor in people with Plaque, Atherosclerotic, run by CHEOL WHAN LEE, M.D., Ph.D at 1 site in South Korea.
Trial summary
Objectives: To compare the effects of clopidogrel versus ticagrelor on atherosclerotic plaque inflammation using serial FDG PET/CT imaging of carotid artery and ascending aorta. Hypothesis: Thrombosis and inflammation are tightly linked rather than separate entities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque, Atherosclerotic
- What is being tested?
- Clopidogrel and Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Aug 2015
- Phase
- Phase 4
- 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
- Men or Women at least 18 years of age inclusive
- Patients with acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC, NSTEMI or STEMI)
- FDG PET/CT shows at least 1 hot uptakes at carotid and or ascending aorta
- The patient or guardian agrees to the study protocol and the schedule of clinical and FDG PET/CT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Who cannot join
- Patients treated with carotid endarterectomy or stent placement
- Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
- Untreated hyperthyroidism, or hypothyroidism
- Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- Evidence of congestive heart failure, or left ventricular ejection fraction < 40%.
- Significant renal disease manifested by serum creatinine > 2.0mg/dL, or creatinine clearance of < 40 ml/min (by Cockcroft-Gault method).
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- Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
- History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).
- Unwillingness or inability to comply with the procedures described in this protocol.
- Patient's pregnant or breast-feeding or child-bearing potential.
- Type I Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation: Serial FDG PET/CT Imaging Study of Carotid Artery and Ascending Aorta
Objectives: To compare the effects of clopidogrel versus ticagrelor on atherosclerotic plaque inflammation using serial FDG PET/CT imaging of carotid artery and ascending aorta.
Hypothesis: Thrombosis and inflammation are tightly linked rather than separate entities. Therefore, P2Y12 receptor inhibitors may have an anti-ischemic effect by inhibiting plaque inflammation, and ticagrelor may be superior in efficacy to clopidogrel.
- Conditions
- Plaque, Atherosclerotic
- Being tested
- Clopidogrel, Ticagrelor
- Keywords
- Plaque, Atherosclerotic, clopidogrel, ticagrelor, Fluorodeoxyglucose F18, Positron-Emission Tomography and Computed Tomography
- Medical subject headings
- Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
75mg once a day
TicagrelorDrug
90mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Active comparator | clopidogrel: 75mg once a day Receives: Drug: Clopidogrel |
| Ticagrelor | Experimental | ticagrelor: 90mg twice a day Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest
Analyses of FDG activity will be quantified on common carotid arteries and ascending aorta of the aortic arch. Primary endpoint is change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest, known as a target-to-background ratio(blood-normalized standardized uptake value).
Measured: 6months
Secondary outcomes (2)
Serial changes of high-sensitivity C-reactive protein
Measured: 6months
Serial changes of lipid battery
lipid battery (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol).
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque, AtheroscleroticStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHEOL WHAN LEE, M.D., Ph.D
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center
- Investigators
- Cheol-whan Lee, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905566
- Sponsor's protocol ID
- AMCCV2012-02
- Status last verified
- Feb 2016
- First submitted
- 19 Jul 2013
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation: Serial FDG PET/CT Imaging Study of Carotid Artery and Ascending Aorta
- ClinicalTrials.gov ID
- NCT01905566
- Acronym / sponsor ID
- AMCCV2012-02
- Conditions
- Plaque, Atherosclerotic
- Keywords
- Plaque, Atherosclerotic, clopidogrel, ticagrelor, Fluorodeoxyglucose F18, Positron-Emission Tomography and Computed Tomography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CHEOL WHAN LEE, M.D., Ph.DUniversity, hospital or other
- Collaborators
- AstraZeneca, CardioVascular Research Foundation, Korea
- Study start
- Sep 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 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.
Objectives: To compare the effects of clopidogrel versus ticagrelor on atherosclerotic plaque inflammation using serial FDG PET/CT imaging of carotid artery and ascending aorta.
Hypothesis: Thrombosis and inflammation are tightly linked rather than separate entities. Therefore, P2Y12 receptor inhibitors may have an anti-ischemic effect by inhibiting plaque inflammation, and ticagrelor may be superior in efficacy to clopidogrel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Active comparator | Drug: Clopidogrelclopidogrel: 75mg once a day |
| Ticagrelor | Experimental | Drug: Ticagrelorticagrelor: 90mg 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 (4 listed)
- Men or Women at least 18 years of age inclusive
- Patients with acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC, NSTEMI or STEMI)
- FDG PET/CT shows at least 1 hot uptakes at carotid and or ascending aorta
- The patient or guardian agrees to the study protocol and the schedule of clinical and FDG PET/CT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Key exclusion criteria (11 listed)
- Patients treated with carotid endarterectomy or stent placement
- Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
- Untreated hyperthyroidism, or hypothyroidism
- Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- Evidence of congestive heart failure, or left ventricular ejection fraction < 40%.
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 |
|---|---|---|
| Clopidogrel75mg once a day | Drug | Clopidogrel |
| Ticagrelor90mg twice a day | Drug | Ticagrelor |
Primary outcome
change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest
Time frame: 6months
Analyses of FDG activity will be quantified on common carotid arteries and ascending aorta of the aortic arch. Primary endpoint is change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest, known as a target-to-background ratio(blood-normalized standardized uptake value).
2 secondary outcomes
Serial changes of high-sensitivity C-reactive protein
Time frame: 6months
Serial changes of lipid battery
Time frame: 6months
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 26 Feb 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.
Cheol-whan Lee, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel and Ticagrelor in people with Plaque, Atherosclerotic, run by CHEOL WHAN LEE, M.D., Ph.D at 1 site in South Korea.
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 11 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 26 Feb 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (follow-up minus baseline) in standardized FDG uptake value within the regions of interest (time frame: 6months). 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 26 Feb 2016.