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Trial record 87 of 360 for:    ASPIRIN AND clopidogrel AND Purinergic Antagonists

Ticagrelor Versus Clopidogrel in Carotid Artery Stenting (PRECISE-MRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02677545
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : March 11, 2020
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
Patients with symptomatic or asymptomatic carotid stenosis in whom carotid artery stenting is planned are randomised between antiplatelet therapy with ticagrelor plus aspirin or clopidogrel plus aspirin and examined with brain MRI before and after stent treatment. The proportion of patients with new ischaemic lesions on MRI after treatment is compared between the two groups.

Condition or disease Intervention/treatment Phase
Carotid Artery Stenosis Drug: Ticagrelor Drug: Clopidogrel Drug: Aspirin Phase 2

Detailed Description:
Carotid artery stenting (CAS) is an emerging treatment for atherosclerotic carotid stenosis. The main adverse event is embolic stroke during the procedure. Current medical management to prevent peri-procedural embolisation consists of dual antiplatelet therapy with clopidogrel and aspirin. Ticagrelor, a novel reversible inhibitor of the platelet adenosine diphosphate receptor P2Y12, was superior to clopidogrel, as add-on therapy to aspirin, in preventing stent thrombosis, cardiovascular outcome events, and death in patients undergoing coronary artery stenting, without causing an increase in major bleeding events. This study aims to test the hypothesis that ticagrelor is superior to clopidogrel as add-on to aspirin in preventing cerebral embolism during the CAS procedure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Cerebral Ischaemia in Stent Treatment for Carotid Artery Stenosis - A Randomised Multi-centre Phase II Trial Comparing Ticagrelor Versus Clopidogrel With Outcome Assessment on MRI (PRECISE-MRI)
Actual Study Start Date : December 2016
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ticagrelor & Aspirin
Participants will receive a loading dose of 180 mg ticagrelor 1-3 days before stenting followed by a maintenance dose of 90 mg twice daily until 28-32 days after stenting. All participants will receive 75-100 mg aspirin per day throughout the study period.
Drug: Ticagrelor
Other Name: Brilique

Drug: Aspirin
Active Comparator: Clopidogrel & Aspirin
Participants will receive a loading dose of 300 mg clopidogrel 1-3 days before stenting followed by a maintenance dose of 75 mg once daily until 28-32 days after stenting. All participants will receive 75-100 mg aspirin per day throughout the study period.
Drug: Clopidogrel
Other Name: Plavix

Drug: Aspirin

Primary Outcome Measures :
  1. At least one new ischaemic brain lesion after CAS [ Time Frame: Up to 32 days after CAS ]
    The primary efficacy outcome is the presence of at least one new ischaemic brain lesion on the second MRI scan done 1-3 days after CAS or on the third MRI scan done 28-32 days after CAS, which had not been present on the first MRI scan done 1-3 days before CAS.

Secondary Outcome Measures :
  1. Composite of any stroke, myocardial infarction, major bleeding, or cardiovascular death [ Time Frame: Through study completion, an average of 1 month after randomisation ]
    The clinical safety outcome is the composite of any stroke, myocardial infarction, major bleeding (including fatal, life-threatening or other major bleeding) or cardiovascular death occurring between randomisation and study completion.

  2. Number of new ischaemic brain lesions after CAS [ Time Frame: Up to 32 days after CAS ]
    A secondary efficacy outcome is the number of new ischaemic brain lesions on the second MRI scan done 1-3 days after CAS or on the third MRI scan done 28-32 days after CAS, which had not been present on the first MRI scan done 1-3 days before CAS.

  3. Volume of new ischaemic brain lesions after CAS [ Time Frame: Up to 32 days after CAS ]
    A secondary efficacy outcome is the total volume of new ischaemic brain lesions on the second MRI scan done 1-3 days after CAS or on the third MRI scan done 28-32 days after CAS, which had not been present on the first MRI scan done 1-3 days before CAS.

  4. At least one new haemorrhagic brain lesion after CAS [ Time Frame: Up to 32 days after CAS ]
    A secondary safety outcome is the presence of at least one new haemorrhagic brain lesion on the second MRI scan done 1-3 days after CAS or on the third MRI scan done 28-32 days after CAS, which had not been present on the first MRI scan done 1-3 days before CAS.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 able to walk unassisted (mRS ≤3) 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 documented on vascular imaging within 90 days before the screening visit);
  • 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 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);
  • 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02677545

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Contact: Leo H Bonati, MD +41615565442

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AZ Groeninge VZW Recruiting
Kortrijk, Belgium, 8500
Contact: Philippe Lerut, Dr.         
Sub-Investigator: Ivan Elegeert, Dr.         
Sub-Investigator: Paul Bourgeois, Dr.         
Sub-Investigator: Bart Mortelé, Dr.         
Sub-Investigator: Nico Callewaert, Prof.         
University Hospital Aachen, Klinik für Diagnostische und Interventionelle Neuroradiologie Recruiting
Aachen, Germany, 52074
Contact: Martin Wiesmann,    +49 241 8089602   
Asklepios Kliniken Hamburg GmbH Recruiting
Hamburg, Germany, 20099
Contact: Bernd Eckert, Prof.Dr.    0049 40 1818-81 18 11   
Contact: Joachim Roether, Prof. Dr.    0049 40 1818811811   
Universitätsklinikum Heidelberg, Neurologische Klinik Recruiting
Heidelberg, Germany, 69120
Contact: Peter Ringleb, Prof. Dr.    +49 6221 56 7660   
Universitätsklinikum Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Contact: Olav Jansen, Dr.    0431 500 ext 23812   
Contact: Johannes Meyne, Dr    0431 500 ext 23812   
Ospedale Civile di Mirano, Department of Cardiology Recruiting
Mirano, Italy, 30035
Contact: Andrea Pacchioni, Dott.ssa    00390415794252   
Contact: Sacca Salvatore, Dott    00390415794252   
UOC Neuroradiologia, Ospedale dell'Angelo Recruiting
Venezia, Italy, 30174
Contact: Enrico Cagliari, MD    +39 0419657182   
AMC Medical Research BV on behalf of Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands, 1105
Contact: Paul J Nederkoorn, MD, PHD    +31 205663446   
Contact: Twan J van Velzen, PHD    +31 205663446   
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584
Contact: Gert J de Borst, Dr    +31 8875569 ext 65   
Contact: Armelle Meershoek, Dr    +31 88 75 569 ext 65   
Kantonsspital Aarau Klinik für Neurologie Recruiting
Aarau, Switzerland, 5001
Contact: Krassen Nedeltchev, Prof-    0041 62 838 41 41   
Contact: Timo Kahles, MD    0041 62 838 66 76   
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Leo H Bonati, MD    +41 61 556 5442   
Insel Gruppe AG, Department of Neurology Recruiting
Bern, Switzerland, 3010
Contact: Marcel Arnold, MD    0041316322111   
Stadtspital Triemli Zürich/Department of Cardiology Recruiting
Zurich, Switzerland, 8063
Contact: Franz H Eberli, MD,FAHA,FESC    +41 44 4163411   
United Kingdom
Sheffield Clinical Research Facility, Northern General Hospital Recruiting
Sheffield, United Kingdom, S57AU
Contact: Trevor Cleveland, Dr    0114 271 ext 4347   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
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Principal Investigator: Leo H Bonati, MD Department of Neurology and Stroke Center, University Hospital Basel
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Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT02677545    
Other Study ID Numbers: D5130C00171; me10Bonati
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data will be available for further analyses. Specific requests will be considered by the Trial Steering Committee.
Additional relevant MeSH terms:
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Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Carotid Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors