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Trial record 98 of 507 for:    ASPIRIN AND P2

A Trial to Assess the Safety and Efficacy of Prophylactic TicagrelOr With Acetylsalicylic Acid Versus CLopidogrel With Acetylsalicylic Acid in the Development of Cerebrovascular EMbolic Events During TAVI (PTOLEMAIOS)

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ClinicalTrials.gov Identifier: NCT02989558
Recruitment Status : Unknown
Verified February 2017 by Dr. Emmanouil Vavouranakis, University of Athens.
Recruitment status was:  Recruiting
First Posted : December 12, 2016
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Emmanouil Vavouranakis, University of Athens

Brief Summary:
Ticagrelor administered with Acetylsalicylic Acid (ASA) will provide better cerebral protection from microembolization in the cerebral circulation during Transcatheter Aortic Valve Implantation (TAVI) and 30 days afterwards, than Clopidogrel plus ASA. This hypothesis will be investigated by measuring the number of High Intensity Transient Signals (HITS) as assessed with transcranial Doppler (TCD) on middle cerebral arteries.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Drug: Ticagrelor plus ASA Drug: Clopidogrel plus ASA Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Multicentre, Randomized, Open Label, Blinded Endpoint, Phase 3 Trial to Assess the Safety and Efficacy of Prophylactic TicagrelOr With Acetylsalicylic Acid Versus CLopidogrel With Acetylsalicylic Acid in the Development of Cerebrovascular EMbolic Events During Transcatheter Aortic Valve Implantation (TAVI) OperationS - the PTOLEMAIOS Study.
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Active Comparator: Ticagrelor plus ASA
Subjects in the Ticagrelor group will receive ASA 80mg qd 7 days prior to the TAVI procedure and for 90 days and Ticagrelor 90mg bid 1 day prior to the TAVI procedure and for 90 days.
Drug: Ticagrelor plus ASA
Subjects in the Ticagrelor group will receive ASA 80mg qd 7 days prior to the TAVI procedure and for 90 days and Ticagrelor 90mg bid 1 day prior to the TAVI procedure and for 90 days.
Other Name: Brilique plus aspirin

Active Comparator: Clopidogrel plus ASA
Subjects in the Clopidogrel group will receive ASA 80mg qd 7 days prior to the TAVI procedure and for 90 days and Clopidogrel as a loading dose of 300 mg 1 day prior to the TAVI procedure and thereafter 75mg qd for 90 days.
Drug: Clopidogrel plus ASA
Subjects in the Clopidogrel group will receive ASA 80mg qd 7 days prior to the TAVI procedure and for 90 days and Clopidogrel as a loading dose of 300 mg 1 day prior to the TAVI procedure and thereafter 75mg qd for 90 days.
Other Name: Clopidogrel plus aspirin




Primary Outcome Measures :
  1. The number of confirmed HITS, as assessed by Transcranial Doppler (TCD), between the two treatment groups during the TAVI procedure. [ Time Frame: During the TAVI procedure ]
    The primary objective is to identify any potential differences between the two treatment groups, subjects receiving Ticagrelor with ASA vs. those receiving Clopidogrel with ASA, in preventing cerebrovascular embolic events during the TAVI procedure, as assessed by measuring the number of HITS with an operative transcranial continuous-function Doppler.


Secondary Outcome Measures :
  1. The incidence of cerebral embolic events between the two treatment groups, as assessed by HITS measured by TCD at subject discharge. [ Time Frame: At day 5, an average at discharge. Data about HITS ]
    The differences in the incidence of cerebral embolic events between the two treatment groups, as assessed by HITS measured by TCD at subject discharge.

  2. the incidence of cerebral embolic events in each treatment group, during the TAVI procedure, and at subject discharge. [ Time Frame: At day 1, procedure day and at day 5, an average at discharge. Data about HITS ]
    The differences in the incidence of cerebral embolic events in each treatment group, as assessed by HITS measured by TCD preoperatively, during the TAVI procedure, and at subject discharge.

  3. The differences between the two treatment groups in induced platelet inhibition, at the day of the procedure. [ Time Frame: At day 1, procedure day. Data about platelet inhibition ]
    The differences between the two treatment groups in induced platelet inhibition, as assessed by the use of the P2Y12 VerifyNow® assay at the day of the procedure.

  4. The differences between the two treatment groups in induced platelet inhibition, at subject discharge. [ Time Frame: At day 5, an average at discharge. Data about platelet inhibition ]
    The differences between the two treatment groups in induced platelet inhibition, as assessed by the use of the P2Y12 VerifyNow® assay at subject discharge.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject (or where unable to do so, their legally acceptable representative) must be able to provide written informed consent prior to any study specific criteria, stating that he or she understands the purpose of and the procedures required for the study and is willing to participate in the study.
  2. Female and/or male subjects aged 18 years or older.
  3. High risk (EuroSCOREa ≥18, or considered inoperable) for surgical aortic valve replacement.
  4. Is expected to benefit from the placement of TAVI.
  5. Does not suffer from any disease or condition that would limit his/her life expectancy of <6 months.
  6. The subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
  7. Subjects must meet the following laboratory results from Visit 0 for study inclusion:

    1. Hemoglobin ≥ 10 g/dL
    2. Platelets ≥ 100 X 103 cells/μL
    3. Absolute neutrophil count (ANC) ≥ 1000 cells/μL
    4. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) levels must be within 1.5 times the upper limit of normal (ULN) range for the laboratory conducting the test.
    5. Total bilirubin ≤ 2x ULN.

Exclusion Criteria:

  1. Have scheduled any elective surgery in the next 4 months following screening procedures.
  2. History of hypocoagulopathy.
  3. Previous thromboembolism or known hypercoagulopathy (acquired or congenital).
  4. Antiplatelet therapy, other than ASA, within 7 days before randomization that cannot be discontinued due to the underlying disease.
  5. History of gastric or duodenal ulcer disease verified by endoscopy or barium meal double-contrast technique within the 3 months.
  6. Moderate or severe hepatic impairment.
  7. Known hypersensitivity to any of the investigational products or their components.
  8. Presence of any other clinically significant disease or disorder which, in the opinion of the Investigator (by its nature or by being inadequately controlled), might put the subject at risk due to participation in the study, or may influence the conduct or the interpretation of the results of the study or the subject's ability to complete the study.
  9. Any identified contraindication for using Ticagrelor, Clopidogrel or ASA.
  10. History or recent findings of atrial fibrillation.
  11. Significant carotid artery disease on either internal carotid artery, as defined by a >50 % diameter reduction on carotid ultrasonography.
  12. Unwillingness to receive or intolerant to any blood products.
  13. Previous trauma or surgery to either femoral vein.
  14. Major surgical procedure or trauma within the 30 days prior to enrolment.
  15. Mechanical heart valve (any location).
  16. Mitral or aortic bioprosthetic valve.
  17. The subject is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.
  18. Reproductive status:

    1. Women who are pregnant or planning a pregnancy within 1 month of the end of study;
    2. Women who are breastfeeding;
    3. Women of childbearing potential who are unwilling or unable to use two highly effective methods of birth control to avoid pregnancy for the entire study period, as evaluated by the Investigator. Women who are not of childbearing potential are those that have a history of hysterectomy, bilateral oophorectomy, or are postmenopausal with no history of menstrual flow for ≥ 12 months prior to the screening Visit.

    Highly effective methods of birth control are defined as:

    Hormonal: established use of oral, implantable, injectable, or transdermal hormonal methods of conception; Placement of an intrauterine device; Placement of an intrauterine system; Mechanical/barrier method of contraception: condom or occlusive cap (diaphragm or cervical/vault cap) in conjunction with spermicide (foam, gel, film, cream or suppository); When used alone, the diaphragm and condom are not highly effective forms of contraception. Therefore the use of additional spermicides provides more effective birth control. However, spermicides alone may not be effective in preventing pregnancy and must be used with a barrier such as a condom or diaphragm.

    Surgical sterilization of male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate; for female patients on the study, the vasectomized male partner should be the sole partner for that patient) in conjunction with spermicide, condom, or diaphragm; Sexual true abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

  19. International normalized ratio (INR) ≥ 2 on the day before the TAVI procedure.
  20. History of hemorrhagic stroke, intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular hemorrhage, intracerebral mass or aneurysm, or arteriovenous malformation.
  21. Severe left ventricular dysfunction (left ventricular ejection fraction<15%).
  22. Severe aortic regurgitation or mitral regurgitation, according to the 2012 European Society of Cardiology and the European Association for Cardio-Thoracic Surgery guidelines (See Appendix 16)
  23. Hemodynamic instability (e.g. requiring inotropic or intra-aortic balloon pump support) within 2 hours of the procedure.
  24. Subject is dialysis dependent.
  25. Any condition requiring the use of anticoagulants that cannot be stopped for the duration of the study.
  26. Acute myocardial infarction, major surgery or any therapeutic cardiac procedure (other than balloon aortic valvuloplasty) within 30 days.
  27. Gastrointestinal or genitourinary bleed within 30 days.
  28. Absolute contraindications or allergy to iodinated contrast that cannot be pre-medicated.
  29. Treatment with other investigational drugs (including investigational vaccines) or devices within the 30 days preceding enrolment or planned use of other investigational drugs or devices before the end of the study.
  30. Known alcohol or drug abuser.
  31. The subject has received any prohibited therapies, as defined in Section 5.7 before the planned first dose of investigational product or is scheduled to receive during the study period. These include, but are not limited to: strong cytochrome P450 3A (CYP3A) inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, erythromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, over 1 litre daily of grapefruit juice), CYP3A substrates with a narrow therapeutic index (cyclosporine, quinidine, simvastatin at doses >40 mg daily, lovastatin at doses >40 mg daily), and strong CYP3A inducers (rifampin/rifampicin, phenytoin, carbamazepine, phenobarbital).

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 ClinicalTrials.gov identifier (NCT number): NCT02989558


Contacts
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Contact: EMMANOUIL VAVOURANAKIS, Ass. Prof 00306945791700 vavouran@otenet.gr
Contact: KONSTANTINOS KALOGERAS, MD 00306932515977 kalogerask@yahoo.gr

Locations
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Greece
1st Department of Cardiology, Hippokration Hospital Recruiting
Athens, Greece
Contact: EMMANOUIL VAVOURANAKIS, Ass. Prof    00306945791700    vavouran@otenet.gr   
Contact: KONSTANTINOS KALOGERAS, MD    00306932515977    kalogerask@yahoo.gr   
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: EMMANOUIL VAVOURANAKIS, Ass. Prof University of Athens, 1st Department of Cardiology, Hippokration Hospital

Publications:
Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schäfers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25.

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Responsible Party: Dr. Emmanouil Vavouranakis, Associate Professor, University of Athens
ClinicalTrials.gov Identifier: NCT02989558     History of Changes
Other Study ID Numbers: D5130C00173
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aspirin
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Clopidogrel
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents