Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02677545 : Ticagrelor Versus Clopidogrel in Carotid Artery Stenting
PhasePhase 2
AgesMin: 40 Years Max: N/A
Eligibility
Inclusion Criteria:

- Written informed consent as documented by signature from the patient;

- Men or women =40 years of age;

- Moderate (50-69% narrowing of the artery according to the measuring method used in the
NASCET trial64) or severe (70-99%) stenosis of the extracranial internal carotid
artery caused by atherosclerosis;

- Symptomatic carotid stenosis (any transient or permanent symptoms caused by focal
ischaemia in the vascular territory supplied by the carotid artery in the past 180
days, including ischaemic stroke, transient ischemic attack (TIA), amaurosis fugax or
ischaemic retinal infarct), as long as the patient is clinically stable and
independent (mRS =2) at the time of randomisation; or asymptomatic carotid stenosis
(no ischaemic symptoms in the past 180 days);

- Stenosis amenable for treatment by CAS according to routine clinical work-up (degree
of stenosis and suitability of vascular anatomy for CAS must be demonstrated either by
consistent findings on two of the following non-invasive imaging modalities: duplex
ultrasound, magnetic resonance angiography, or computer tomography angiography; or by
intra-arterial digital subtraction angiography);

- CAS scheduled to take place within 1-3 days of randomisation.

Exclusion Criteria:

- Inability or unwillingness of the patient to understand and/or comply with study
procedures and/or follow-up, e.g. due to language problems, psychological disorders,
dementia, etc.;

- Women who are pregnant or breast feeding, or who intend to become pregnant during the
course of the study. Women of childbearing age must take a pregnancy test to be
eligible for the study;

- Lack of safe contraception, defined as: Female Participants of childbearing potential,
not using and not willing to continue using a medically reliable method of
contraception for the entire study duration, such as oral, injectable, or implantable
contraceptives, or intrauterine contraceptive devices, or who are not using any other
method considered sufficiently reliable by the Investigator in individual cases.
Female Participants who are surgically sterilised / hysterectomised or post-menopausal
for longer than 2 years are not considered as being of child bearing potential;

- Acute ischaemic stroke with symptom onset in the previous 24 hours before
randomisation;

- atrial fibrillation;

- Fresh thrombus in the relevant carotid artery;

- Patient clinically unstable at the time of randomisation (includes worsening in NIH
Stroke Scale of >2 points over the previous 24 hours);

- Patient dependent on others in functions of daily living at the time of randomisation
(mRS >2);

- Patients with known bleeding diathesis or coagulation disorder (e.g.,
thrombotic-thrombocytopenic purpura);

- Any active pathological bleed;

- Severe thrombocytopenia (platelet count <50'000/uL);

- History of previous symptomatic intracranial haemorrhage at any time (asymptomatic
microbleeds do not qualify)

- History of gastrointestinal bleed within the past 6 months;

- Any contraindication to non-contrast MRI, including but not limited to: cardiac
pacemaker incompatible with MRI; metal implants incompatible with MRI;
claustrophobia);

- Contraindications to ticagrelor, clopidogrel, or acetylsalicylic acid (ASA), or to any
of their excipients, including known hypersensitivity or allergy;

- Increased risk of bradycardic events (e.g., patients without a pacemaker who have sick
sinus syndrome, 2nd or 3rd degree atrioventricular (AV) block, or history of
bradycardia-related syncope;

- Need for medication not permitted during treatment period: Antithrombotic therapy
other than Study Medication or permitted concomitant medication (see section 8.7)
including: Antiplatelet therapy (other than ASA 100 mg daily), e.g.: open-label
clopidogrel or ticagrelor; GPIIb/GPIIIa inhibitors, ticlopidine, prasugrel,
dipyridamole, ozagrel, cilostazol; Therapeutic-dose anticoagulation (other than
unfractioned heparin at the start of the CAS procedure), e.g.: phenprocoumon,
warfarin, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban,
unfractionated and low molecular weight heparins; Receipt of any intravenous or
intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to
randomisation. If a patient requires intravenous or intra-arterial thrombolytic
therapy during the treatment period, the Study Medication must be discontinued for at
least 24 hours; Strong cytochrome P450 3A (CYP3A) inhibitors leading to substantial
increases in ticagrelor plasma levels: ketoconazole, itraconazole, voriconazole,
telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone,
ritonavir, saquinavir, nelfinavir, indinavir, atazanavir; or consumption of more than
1 litre of grapefruit juice daily; Strong CYP3A inducers leading to substantial
decreases in ticagrelor plasma levels: rifampicin, rifabutin, phenytoin,
carbamazepine, and phenobarbital; CYP3A substrates with narrow therapeutic indices
which may be substantially increased by co-administration of ticagrelor: cyclosporine,
quinidine, simvastatin at doses >40 mg daily or lovastatin at doses >40 mg daily.
(Co-administration of ticagrelor with simvastatin increases simvastatin Cmax by 81%
and area under curve (AUC) by 56% and increases simvastatin acid Cmax by 64% and AUC
by 52% with some individual increases equal to 2- to 3-fold. Ticagrelor may have
similar effect on lovastatin, but is not expected to have a clinically meaningful
effect on other statins including atorvastatin and rosuvastatin); Anticipated
requirement for long-term (>7 days) non-steroidal anti-inflammatory drugs (NSAIDs;
short-term treatment with NSAIDs up to 7 days is allowed during the treatment period
at the investigator's discretion);

- Need for invasive procedure (surgery or intervention) other than the index CAS
procedure for which the patient was randomised, which requires halting of Study
Medication within the next 30 days after randomisation;

- History of major surgery within the past 30 days;

- Moderate or severe hepatic impairment;

- Renal impairment requiring dialysis;

- Known or suspected non-compliance, drug or alcohol abuse;

- Previous enrolment into the present study;

- Participation in another study with investigational drug within the 30 days preceding
and during the present study;

- Patients incapable of judgment or patients under tutelage;

- Enrolment of the Investigator, his/her family members, employees and other dependent
persons;
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02677545      |      Link to official Clinicaltrials.gov listing
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