Coronary Artery DiseasePhase 2NOVELTYNCT02071212
Compare Ticagrelor vs Clopidogrel on the Reduction of Arterial Stiffness and Wave Reflectionsin Patients With CAD.
A Phase 2 study testing Ticagrelor in people with Coronary Artery Disease, run by Hellenic Cardiovascular Research Society at 1 site in Greece.
Trial summary
The purpose of this study is to investigate the potential acute and chronic effect of ticagrelor versus clopidogrel on arterial stiffness and other vascular risk markers of interest, the study will consist of two periods: a 24-hour ACUTE period where 60 subjects with an indication for coronary angiography (CA) with or… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- Feb 2014to Jun 2018
- Phase
- Phase 2
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures.
- Male and female subjects > 18 and < 79 years of age.
- Indication for elective coronary angiography (angina, positive stress test/SPECT/stress echo) with or without PCI for inclusion in the 'acute' study period, and indication for either ad hoc or elective PCI for inclusion in the 'chronic' study period.
Who cannot join
- Who had ACS within 12 months of screening.
- Previous stent implantation with dual antiplatelet therapy within 12 months of screening.
- Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.
- Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction < 30%.
- Subjects with hemodynamic or electrical instability (including shock).
- History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
Show all 29Show fewer
- Other bleeding diathesis, or considered by Investigator to be at high risk for bleeding.
- Any previous history of ischemic or hemorrhagic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- International Normalized Ratio (INR) known to be >1.5 within 1 week of study entry.
- Poorly controlled blood pressure (>160/100 mmHg).
- Known platelet count of <100,000/mm3 within 1 week of study entry.
- Known anemia (hemoglobin [Hb] <10 gr/dL) within 1 week of study entry.
- Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
- Severe kidney disease (GFR<30 ml/min/1.73m2).
- Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase greater than 3 times the upper limit of normal or hyperbilirubinemia defined as peak total serum bilirubin greater than 2 times the upper limit of normal (ULN).
- Any indication (atrial fibrillation, mitral stenosis or prosthetic heart valve, pulmonary embolism (PE), deep vein thrombosis (DVT)) for anticoagulation treatment during study period.
- Asthma or chronic obstructive pulmonary disease requiring brochodilating agents.
- Concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine).
- Concomitant use of drugs that are metabolized through CYP2C19 (omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine and chloramphenicol).
- History of uric acid nephropathy and high levels of uric acid within 1 week of study entry.
- Increased risk of bradycardic events (e.g. known sick sinus syndrome or third degree AV block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker).
- Known neoplastic or autoimmune disease or any concomitant medical illness that in the opinion of the Investigator may interfere with or prevent completion in this study.
- Contraindication to clopidogrel, ASA, or ticagrelor.
- A history of alcohol and/or substance abuse that could interfere with conduct of the trial.
- Pregnancy or lactation (for premenopausal women 2 methods of reliable contraception, one of which must be barrier method, are required).
- Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
- Life expectancy less than 1 year.
- Indication for major surgery (e.g. cancer treatment, carotid surgery, cerebral surgery, major vascular surgery).
- High likelihood of being unavailable for the Day 30 follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center Phase II Assessor-Blinded RaNdomised Active Controlled Parallel-Group Trial to COmpare Ticagrelor Versus Clopidogrel on the REduction of ArteriaL STiffness and Wave Reflections in Patients With CoronarY Artery Disease.
The purpose of this study is to investigate the potential acute and chronic effect of ticagrelor versus clopidogrel on arterial stiffness and other vascular risk markers of interest, the study will consist of two periods: a 24-hour ACUTE period where 60 subjects with an indication for coronary angiography (CA) with or without percutaneous coronary intervention (PCI) will be included, and a 30-day CHRONIC period where approximately 60 subjects that will undergo PCI will be included and studied (refer to Section 3 'Study Plan and Procedures'). The primary objective of this study is to compare ticagrelor versus clopidogrel regarding their effect on arterial stiffness as assessed by PWV, at 3 hours after the loading dose of each regimen, in eligible subjects with CAD.
Read the detailed description
This is singe-center, randomized, assessor-blinded, active controlled, parallel-group trial consisting of an 'acute' and a 'chronic' period, aiming at comparing ticagrelor versus clopidogrel on the reduction of arterial stiffness and wave reflections in patients with CAD. This Investigator-Sponsored Study (ISS) will be supported by AstraZeneca.
60 subjects fulfilling all study-specific eligibility criteria will be initially recruited for the 'acute' study period of 24-hour duration. Subjects that will undergo ad hoc PCI will continue in the subsequent 'chronic' study period of 30-day duration.
In order to have 60 subjects in the 'chronic' study period (since some of the 'acute' period will not undergo PCI), additional subjects that are scheduled for elective PCI will be recruited until the sample size of 'chronic' study period reaches 60 subjects.
The study periods [Figure 1, Flow Chart] have as follows:
For the 24-hour ACUTE period, 60 subjects with an indication for elective CA with or without PCI will be included in the study.
Three (3) hours before the CA the subjects will be randomized in the two study treatment arms:
Ticagrelor arm: 30 subjects will receive
- 180 mg loading dose of ticagrelor,
- 1st maintenance ticagrelor dose of 90 mg at 12 hours. Clopidogrel arm: 30 subjects will receive
- 600 mg loading dose of clopidogrel.
Study measurements (arterial stiffness, central blood pressure and endothelial function) for both study treatment arms will be performed at:
- baseline (0 hours - prior to the loading dose administration)
- 3 hours (after the loading dose of each regimen and before CA), and at
- 24 hours (before the administration of the 2nd maintenance dose of ticagrelor and the 1st maintenance dose of clopidogrel).
For the 30-day CHRONIC period, 60 subjects that will undergo PCI (stent implantation) will be studied. Part of this 'chronic' period population will consist of the subjects that were included in the 'acute' period and proceeded ad hoc to PCI. The remainder will be subjects being scheduled for elective PCI, who will be enrolled after the completion of the recruitment in the 'acute' study period.
Approximately 30 subjects will be allocated to ticagrelor loading dose and maintenance dose (90 mg BID) thereafter and approximately 30 subjects will be allocated to 600 mg of clopidogrel and maintenance dose (75 mg QD) thereafter.
Study measurements for the subjects of the 'acute' period that will enter the 'chronic' period will be performed at:
- 30 days post-PCI (prior to the administration of the morning maintenance dose of the assigned treatment regimen at the day of study visit).
Study measurements for the additional subjects with indication of elective PCI that will be enrolled directly into the chronic study period will be performed at:
- baseline (0 hours - prior to the administration of the loading dose of each treatment regimen and 3 hours before the PCI)
- 30 days post PCI (prior to the administration of the morning maintenance dose of the assigned treatment regimen at the day of study visit).
All study-related procedures will be carried out in accordance with the institutional guidelines and common practice.
- Conditions
- Coronary Artery Disease
- Being tested
- Ticagrelor
- 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 BRILIQUE
Loading dose 180 mg . Maintainance dose 90 mg BID
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Active comparator | Loading dose 600 mg .Mainatinance dose 75 mg QD Receives: Drug: Ticagrelor |
| Ticagrelor | Experimental | Loading dose 180 mg . Maintenance 90 mg BID Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in the cfPWV
The primary outcome is the treatment difference in the mean change in cfPWV from baseline (0 hours) at 3 hours after the loading dose of each regimen, in ticagrelor and clopidogrel acute period populations.
Measured: at 3 hours after the loading dose
Secondary outcomes (1)
mean change in the cfPWV
The treatment difference in the mean change in the cfPWV from baseline (0 hours) at 24 hours after the loading dose of each regimen, in the acute period populations;
Measured: from baseline at 24 hours after the loading dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2018
- Study completionJun 2018
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cardiovascular Research Society
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Charalambos Vlachopoulos, Principal investigator, Ippokratio Hospital Athens , Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071212
- Sponsor's protocol ID
- D5130L00063
- Acronym
- NOVELTY
- Status last verified
- Jun 2019
- First submitted
- 21 Feb 2014
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Vlachopoulos C, Georgakopoulos C, Pietri P, Ioakeimidis N, Koutouzis M, Vaina S, Aznaouridis K, Toutouzas K, Latsios G, Terentes-Printzios D, Rigatou A, Tousoulis D. Effect of Ticagrelor Versus Clopidogrel on Aortic Stiffness in Patients With Coronary Artery Disease. J Am Heart Assoc. 2019 Jun 18;8(12):e012521. doi: 10.1161/JAHA.119.012521. Epub 2019 Jun 5.
PubMed 31165663
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Phase II Assessor-Blinded RaNdomised Active Controlled Parallel-Group Trial to COmpare Ticagrelor Versus Clopidogrel on the REduction of ArteriaL STiffness and Wave Reflections in Patients With CoronarY Artery Disease.
- ClinicalTrials.gov ID
- NCT02071212
- Acronym / sponsor ID
- NOVELTY / D5130L00063
- Conditions
- Coronary Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hellenic Cardiovascular Research SocietyUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Feb 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 25 Feb 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.
The purpose of this study is to investigate the potential acute and chronic effect of ticagrelor versus clopidogrel on arterial stiffness and other vascular risk markers of interest, the study will consist of two periods: a 24-hour ACUTE period where 60 subjects with an indication for coronary angiography (CA) with or without percutaneous coronary intervention (PCI) will be included, and a 30-day CHRONIC period where approximately 60 subjects that will undergo PCI will be included and studied (refer to Section 3 'Study Plan and Procedures'). The primary objective of this study is to compare ticagrelor versus clopidogrel regarding their effect on arterial stiffness as assessed by PWV, at 3 hours after the loading dose of each regimen, in eligible subjects with CAD.
Detailed description
This is singe-center, randomized, assessor-blinded, active controlled, parallel-group trial consisting of an 'acute' and a 'chronic' period, aiming at comparing ticagrelor versus clopidogrel on the reduction of arterial stiffness and wave reflections in patients with CAD. This Investigator-Sponsored Study (ISS) will be supported by AstraZeneca.
60 subjects fulfilling all study-specific eligibility criteria will be initially recruited for the 'acute' study period of 24-hour duration. Subjects that will undergo ad hoc PCI will continue in the subsequent 'chronic' study period of 30-day duration.
In order to have 60 subjects in the 'chronic' study period (since some of the 'acute' period will not undergo PCI), additional subjects that are scheduled for elective PCI will be recruited until the sample size of 'chronic' study period reaches 60 subjects.
The study periods [Figure 1, Flow Chart] have as follows:
For the 24-hour ACUTE period, 60 subjects with an indication for elective CA with or without PCI will be included in the study.
Three (3) hours before the CA the subjects will be randomized in the two study treatment arms:
Ticagrelor arm: 30 subjects will receive
- 180 mg loading dose of ticagrelor,
- 1st maintenance ticagrelor dose of 90 mg at 12 hours. Clopidogrel arm: 30 subjects will receive
- 600 mg loading dose of clopidogrel.
Study measurements (arterial stiffness, central blood pressure and endothelial function) for both study treatment arms will be performed at:
- baseline (0 hours - prior to the loading dose administration)
- 3 hours (after the loading dose of each regimen and before CA), and at
- 24 hours (before the administration of the 2nd maintenance dose of ticagrelor and the 1st maintenance dose of clopidogrel).
For the 30-day CHRONIC period, 60 subjects that will undergo PCI (stent implantation) will be studied. Part of this 'chronic' period population will consist of the subjects that were included in the 'acute' period and proceeded ad hoc to PCI. The remainder will be subjects being scheduled for elective PCI, who will be enrolled after the completion of the recruitment in the 'acute' study period.
Approximately 30 subjects will be allocated to ticagrelor loading dose and maintenance dose (90 mg BID) thereafter and approximately 30 subjects will be allocated to 600 mg of clopidogrel and maintenance dose (75 mg QD) thereafter.
Study measurements for the subjects of the 'acute' period that will enter the 'chronic' period will be performed at:
- 30 days post-PCI (prior to the administration of the morning maintenance dose of the assigned treatment regimen at the day of study visit).
Study measurements for the additional subjects with indication of elective PCI that will be enrolled directly into the chronic study period will be performed at:
- baseline (0 hours - prior to the administration of the loading dose of each treatment regimen and 3 hours before the PCI)
- 30 days post PCI (prior to the administration of the morning maintenance dose of the assigned treatment regimen at the day of study visit).
All study-related procedures will be carried out in accordance with the institutional guidelines and common practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Active comparator | Drug: TicagrelorLoading dose 600 mg .Mainatinance dose 75 mg QD |
| Ticagrelor | Experimental | Drug: TicagrelorLoading dose 180 mg . Maintenance 90 mg BID |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study specific procedures.
- Male and female subjects > 18 and < 79 years of age.
- Indication for elective coronary angiography (angina, positive stress test/SPECT/stress echo) with or without PCI for inclusion in the 'acute' study period, and indication for either ad hoc or elective PCI for inclusion in the 'chronic' study period.
Key exclusion criteria (29 listed)
- Who had ACS within 12 months of screening.
- Previous stent implantation with dual antiplatelet therapy within 12 months of screening.
- Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.
- Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction < 30%.
- Subjects with hemodynamic or electrical instability (including shock).
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: BRILIQUELoading dose 180 mg . Maintainance dose 90 mg BID | Drug | Clopidogrel, Ticagrelor |
Primary outcome
Mean Change in the cfPWV
Time frame: at 3 hours after the loading dose
The primary outcome is the treatment difference in the mean change in cfPWV from baseline (0 hours) at 3 hours after the loading dose of each regimen, in ticagrelor and clopidogrel acute period populations.
1 secondary outcome
mean change in the cfPWV
Time frame: from baseline at 24 hours after the loading dose
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 19 Jun 2019.
- Derived from this study: PubMed 31165663Vlachopoulos C, Georgakopoulos C, Pietri P, Ioakeimidis N, Koutouzis M, Vaina S, Aznaouridis K, Toutouzas K, Latsios G, Terentes-Printzios D, Rigatou A, Tousoulis D. Effect of Ticagrelor Versus Clopidogrel on Aortic Stiffness in Patients With Coronary Artery Disease. J Am Heart Assoc. 2019 Jun 18;8(12):e012521. doi: 10.1161/JAHA.119.012521. Epub 2019 Jun 5.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Charalambos Vlachopoulos principal investigator
Ippokratio Hospital Athens , Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ticagrelor in people with Coronary Artery Disease, run by Hellenic Cardiovascular Research Society at 1 site in Greece.
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 3 inclusion and 29 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 19 Jun 2019. 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 Greece. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean Change in the cfPWV (time frame: at 3 hours after the loading dose). 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 NCT02071212, 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 19 Jun 2019.