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    Summary
    EudraCT Number:2011-004064-29
    Sponsor's Protocol Code Number:CS747S-B-U4003
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2011-004064-29
    A.3Full title of the trial
    A PHARMACODYNAMIC EVALUATION OF SWITCHING FROM TICAGRELOR TO PRASUGREL IN SUBJECTS WITH STABLE CORONARY ARTERY DISEASE: 2ND SWITCHING ANTIPLATELET AGENTS (SWAP 2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial investigating the effects of switching from one anitiplatelet drug to another in subject with stable Coronary Artery Disease
    A.3.2Name or abbreviated title of the trial where available
    SWAP 2
    A.4.1Sponsor's protocol code numberCS747S-B-U4003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDaiichi Sankyo, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDaiichi Sankyo, Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportEli Lilly
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo, Inc.
    B.5.2Functional name of contact pointMedical Research and Strategy
    B.5.3 Address:
    B.5.3.1Street Address2 Hilton Court
    B.5.3.2Town/ cityParsippany
    B.5.3.3Post codeNJ 07054
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019739442600
    B.5.5Fax number001 9739442645
    B.5.6E-mailmrozek@dsi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePrasugrel hydrochloride
    D.3.2Product code Prasugrel
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 389574-19-0
    D.3.9.2Current sponsor codeCS-747 hydrochloride salt, LY640315
    D.3.9.3Other descriptive nameLY640315
    D.3.9.4EV Substance CodeSUB30236
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Brilique
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code Ticagrelor
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTicagrelor
    D.3.9.1CAS number 274693-27-5
    D.3.9.2Current sponsor codeTicagrelor
    D.3.9.3Other descriptive nameTICAGRELOR
    D.3.9.4EV Substance CodeSUB30898
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stable Coronary Artery Disease
    E.1.1.1Medical condition in easily understood language
    Heart Disease
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10013098
    E.1.2Term Disease coronary artery
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the pharmacodynamic (PD) effects, expressed as P2Y12 reaction units (PRU) by the VerifyNow P2Y12 assay, in subjects with stable coronary artery disease (CAD), treated with prasugrel 10 mg daily (QD) maintenance dose (MD) (Arms A + B) and in subjects treated with ticagrelor 90 mg twice daily (BID) MD (Arm C), after 7 days of randomized study treatment.
    E.2.2Secondary objectives of the trial
    To compare the PD effects measured:

    *By the Vasodilator-stimulated phosphoprotein (VASP) assay (platelet reactivity index [PRI]), in all subjects treated with prasugrel 10 mg QD MD (Arms A + B) and in subjects treated with ticagrelor 90 mg BID MD (Arm C) after 7 days of randomized treatment
    *Using the VerifyNow Assay device-reported and calculated percent inhibition in subjects treated on Arms A + B and in subjects treated on Arm C after 7 days of randomized treatment

    To compare the PD effects, in terms of PRU, VerifyNow Assay device-reported and calculated percent inhibition, and PRI, in subjects treated on:

    *Arm A (prasugrel 60 mg loading dose [LD] + 10 mg QD MD) and in subjects treated on Arm C (ticagrelor 90 mg BID MD), at all time points
    *Arm B (prasugrel 10 mg QD MD) vs. Arm C (ticagrelor 90 mg BID MD), at all time points
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    As emerging information regarding the safety and efficacy of thienopyridines and cyclopentyltriazolopyrimidines may become available in the future, all subjects will have the option to allow a pharmacogenomic blood sample to be taken and retained for possible future research. This is optional. Additional blood would be drawn at visit 3.
    E.3Principal inclusion criteria
    1. Male or female; age ≥ 18 and < 75 years
    2. Weight ≥ 60 kg
    3.Receiving low dose ASA (75 mg to 150 mg daily) for at least 7 days at the time of Visit 1 and able to continue the same regimen throughout the study
    4. Stable CAD. CAD is defined as any of the following:
    a. History of a positive stress test
    b. Previous coronary revascularization including percutaneous coronary intervention (PCI), stent, or coronary artery bypass graft (CABG)
    c. Angiographic demonstration of CAD (at least 1 lesion ≥ 50 percent)
    d. Presence of at least moderate plaque by computed tomography (CT) angiography
    e. Electron beam CT coronary artery calcification score > 100 Agatston units
    5. If female, may be enrolled if
    One of the following 3 criteria are met:
    i. Had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form (ICF)
    ii. Post-menopausal for at least 1 year
    iii. If of childbearing potential, will practice 1 of the following methods of birth control throughout the study: oral, injectable, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide; or female condom plus spermicide. Methods of contraception that are not acceptable are partner’s use of condoms or partner’s vasectomy
    6. Able and willing to provide written informed consent before entering the study
    E.4Principal exclusion criteria
    1. Have a defined need for adenosine diphosphate (ADP)-receptor inhibitor therapy, such as any of the following (or any other condition that in the Investigator’s judgment would require such therapy):

    a. Within ≤ 12 months of an acute coronary syndrome (ACS) event (unstable angina [UA], non-ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]) regardless of initial treatment (that is, invasive versus noninvasive)

    b. Subjects who underwent angioplasty within 12 months including bare-metal stent and/or a drug-eluting stent
    c. Had any stent placed in an unprotected left main coronary artery or in the last patent artery within the last 12 months

    2. Received thienopyridine therapy within 30 days of study entry

    3. Plan to undergo coronary revascularization at any time during the trial

    4. Presence or history of any of the following: ischemic or hemorrhagic stroke; transient ischemic attack (TIA); intracranial neoplasm; arteriovenous malformation, or aneurysm; intracranial hemorrhage; head trauma (within 3 months of study entry)

    5. History of refractory ventricular arrhythmias with an increased risk of bradycardic events (eg, subjects without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree atrioventricular (AV) block or bradycardic-related syncope)

    6. History or evidence of congestive heart failure (New York Heart Association Class III or above)

    7. Severe hepatic impairment

    8. History of uric acid nephropathy

    9. Uncontrolled hypertension, or systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg at screening

    10. Severely impaired renal function (glomerular filtration rate < 30 mL/minute) or on dialysis

    11. At risk for bleeding

    12.Taking prohibited medications

    13.Meets any of the general exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    PRU by VerifyNow P2Y12 assay for prasugrel 10 mg QD MD (Arm A + B) and ticagrelor 90 mg BID MD (Arm C) after 7 days of randomized treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 7 days of randomized treatment.
    E.5.2Secondary end point(s)
    • PRI by the VASP assay 2, 4, 24, 48 hours, and 7 days after first randomized study treatment
    • PRU by the VerifyNow P2Y12 assay 2, 4, 24, and 48 hours after first randomized study treatment
    • VerifyNow assay device-reported and calculated percent inhibition 2, 4, 24, and 48 hours, and 7 days after first randomized study treatment
    • Percentage of subjects with HPR, defined as a) ≥ 208 PRU and b) ≥ 230 PRU by the VerifyNow P2Y12 assay, and c) >50% PRI by the VASP assay, 2, 4, 24, and 48 hours and 7 days after first randomized study treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    See above section E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Different dosage of the same product
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 105
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-13
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    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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