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 blood pregnancy test to be eligible for the study within 14 days before randomisation
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 unable to walk unassisted at the time of randomisation (mRS >3)
Patients with known bleeding diathesis or coagulation disorder (e.g., thrombotic-thrombocytopenic purpura)
Any active pathological bleed
Severe thrombocytopenia (platelet count <50'000/uL); platelet count must be documented within 30 days before randomisation
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; ECG must be obtained within 30 days before randomisation
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)
Yes for 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) exclusion criteria 17
No for 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) exclusion criteria 17
Not sure for 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) exclusion criteria 17
Need for any cardio-vascular surgery or cardio-vascular intervention other than the index CAS procedure for which the patient was randomised within the next 30 days after randomisation
Need for any other 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