- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02071212
Compare Ticagrelor vs Clopidogrel on the Reduction of Arterial Stiffness and Wave Reflectionsin Patients With CAD. (NOVELTY)
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
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Athens, Grekland
- Ippokratio Hospital
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Clopidogrel
Loading dose 600 mg .Mainatinance dose 75 mg QD
|
Loading dose 180 mg .
Maintainance dose 90 mg BID
Andra namn:
|
Experimentell: Ticagrelor
Loading dose 180 mg .
Maintenance 90 mg BID
|
Loading dose 180 mg .
Maintainance dose 90 mg BID
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Mean Change in the cfPWV
Tidsram: 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.
|
at 3 hours after the loading dose
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
mean change in the cfPWV
Tidsram: from baseline at 24 hours after the loading dose
|
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;
|
from baseline at 24 hours after the loading dose
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Charalambos Vlachopoulos, Ippokratio Hospital Athens , Greece
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hjärtsjukdom
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Arterioskleros
- Arteriella ocklusiva sjukdomar
- Kranskärlssjukdom
- Myokardischemi
- Kranskärlssjukdom
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Trombocytaggregationshämmare
- Purinerga P2Y-receptorantagonister
- Purinerga P2-receptorantagonister
- Purinerga antagonister
- Purinerga medel
- Ticagrelor
Andra studie-ID-nummer
- D5130L00063
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