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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-003595-11
    Sponsor's Protocol Code Number:POISE
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-06-08
    Trial 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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-003595-11
    A.3Full title of the trial
    clinical trial metoprolol vs. placebo in patients about to undergo in non cardiac surgery and have moderate or high risk of perioperative cardiac effects (PeriOperative ISchemic Evaluation study)
    Ensayo clínico de metoprolol vs placebo en pacientes que van a ser sometidos a cirugía no cardiaca y que estén en riesgo moderado o alto de sufrir eventos cardíacos perioperatorios (PeriOperative ISchemic Evaluation study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    clinical trial metoprolol vs. placebo in patients about to undergo in non cardiac surgery and have moderate or high risk of perioperative cardiac effects (PeriOperative ISchemic Evaluation study)
    Ensayo clínico de metoprolol vs placebo en pacientes que van a ser sometidos a cirugía no cardiaca y que estén en riesgo moderado o alto de sufrir eventos cardíacos perioperatorios (PeriOperative ISchemic Evaluation study)
    A.3.2Name or abbreviated title of the trial where available
    POISE
    A.4.1Sponsor's protocol code numberPOISE
    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 SponsorAsociación Colaboración Cochrane Iberoamericana (ACCIb)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAsociación Colaboración Cochrane Iberoamericana (ACCIb)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAsociación Colaboración Cochrane Iberoamericana (ACCIb)
    B.5.2Functional name of contact pointXavier Bonfill
    B.5.3 Address:
    B.5.3.1Street AddressSant Antoni Mª Claret 171
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.3.4CountrySpain
    B.5.4Telephone number34932919527
    B.5.5Fax number34932919525
    B.5.6E-mailxbonfill@santpau.es
    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 Yes
    D.2.1.1.1Trade name Betaloc
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameMetoprolol succinato (D.C.I.), 190 mg (equivalente a 200 mg de metoprolol tartrato) Excipiente, c.s.
    D.3.2Product code 00719846
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETOPROLOL SUCCINATE
    D.3.9.1CAS number 98418-47-4
    D.3.9.4EV Substance CodeSUB03274MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number190
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with moderate or high cardiovascular risk (atherosclerotic disease, coronary disease) undergoing in non cardiac surgery
    Pacientes con moderado a alto riesgo cardiovascular (pacientes con enfermedad
    cardiovascular ateroesclerótica o pacientes con un riesgo alto de enfermedad coronaria)
    que son sometidos a cirugía no cardiaca.
    E.1.1.1Medical condition in easily understood language
    patients with moderate or high cardiovascular risk (atherosclerotic disease, coronary disease) undergoing in non cardiac surgery
    Pacientes con moderado a alto riesgo cardiovascular
    que son sometidos a cirugía no cardiaca
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the impact of perioperative administration of metoprolol on
    cardiovascular events (defined as cardiovascular death, non-fatal myocardial infarction and nonfatal cardiac arrest) in the first 30 days post-surgery in patients
    with moderate to high cardiovascular risk (patients with cardiovascular disease
    atherosclerotic or patients at high risk of coronary heart disease) that are
    noncardiac surgery.
    Determinar el impacto de la administración perioperatoria de metoprolol sobre los
    eventos cardiovasculares (definidos como muerte cardiovascular, infarto del miocardio
    no fatal y parada cardiaca no fatal) en los primeros 30 días postquirúrgicos en pacientes
    con moderado a alto riesgo cardiovascular (pacientes con enfermedad cardiovascular
    ateroesclerótica o pacientes con un riesgo alto de enfermedad coronaria) que son
    sometidos a cirugía no cardiaca.
    E.2.2Secondary objectives of the trial
    1. To determine the impact of perioperative administration of metoprolol determine the effect of the risk at 30 days to develop
    heart failure.
    2. To determine the effect of metoprolol on 30-day risk of developing
    Clinically significant bradycardia (bradycardia requiring temporary pacemaker,
    sympathomimetic agents, atropine, or suspension of study drug).
    3. To determine the effect of metoprolol on 30-day risk of developing
    Clinically significant hypotension (systolic blood pressure <90 mmHg
    required resuscitation with parenteral fluids, intraaortic balloon, agents
    inotropic or suspension of study drug)
    Determinar el efecto del metoprolol sobre el riesgo a 30 días de desarrollar
    insuficiencia cardiaca.
    2. Determinar el efecto del metoprolol sobre el riesgo a 30 días de desarrollar
    bradicardia clínicamente significativa (bradicardia que requiera marcapaso temporal,
    agentes simpaticomiméticos, atropina, o suspensión de la droga del estudio).
    3. Determinar el efecto del metoprolol sobre el riesgo a 30 días de desarrollar
    hipotensión clínicamente significativa (tensión arterial sistólica < 90 mmHg que
    requiera resucitación con líquidos parenterales, balón intraortico, agentes
    inotrópicos o suspensión de la droga del estudio)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible if they are undergoing non cardiac surgery; age > 45 years, have an expected length of hospital stay > 24 hours for surgical reasons, AND fulfill any one of the following six criteria: history of coronary artery disease, peripheral vascular disease, history of stroke thought due to atherothrombotic disease, hospitalization for congestive heart failure within 3 years of randomization, undergoing major vascular surgery OR fulfill any 3 of the following 7 risk factors: undergoing high-risk type surgery (intrathoracic, intraperitoneal), any history of congestive heart failure, diabetes and currently on an oral hypoglycemic agent or insulin therapy, pre-operative serum creatinine > 175 µmol/L (>2.0 mg/dl), age > 70 years, history of transient ischemic attack, undergoing emergency/urgent
    E.4Principal exclusion criteria
    Contraindication to metoprolol including any of the following: significant bradycardia (heart rate < 50 beats per minute); second or third degree heart block without a pacemaker; asthma that has been active within the last decade (i.e. a clinical diagnosis of asthma and use of regular inhaled steroids, or beta agonists at least once per week over the period of a month, any time in the last ten years); and a history of COPD with bronchospasm on pulmonary function tests (i.e. an increase in FEV1 > 12% and of at least 200 ml, 15 minutes after inhalation of a beta 2 – agonist). Clinical plan to use a beta-blocker preoperatively or during the first 30 postoperative days Prior adverse reaction to a beta-blocker CABG surgery with complete revascularization in the preceding 5 years and no evidence of cardiac ischemia since the CABG surgery Patients undergoing low risk surgical procedures (e.g. transurethral procedures [transurethral prostatectomies (TURPs), stone baskets, etc], ophthalmologic procedures under topical or regional anesthesia [cornea transplants, cataract surgery, etc], and surgeries with limited physiological stresses [digital re-implantation, nerve repairs, etc] ) Concurrent use of verapamil; OR Prior enrollment in this trial
    E.5 End points
    E.5.1Primary end point(s)
    Cardiovascular events (cardiavascular death, non fatal miocardic infarction, and cardiac arrest)
    Eventos cardiovasculares (definidos como muerte cardiovascular, infarto del miocardio no fatal
    y parada cardiaca no fatal)
    E.5.1.1Timepoint(s) of evaluation of this end point
    first 30 days post surgery
    primeros 30 días post cirugía
    E.5.2Secondary end point(s)
    Long-term risk of total mortality, cardiovascular death and nonfatal myocardial infarction.
    Hospital stay and intensive care.
    significant risk of atrial fibrillation, rehospitalization for cardiac causes, nonfatal myocardial infarction, cardiac arrest, cardiovascular death, total mortality and the need for revascularization procedures (coronary bypass and percutaneous transluminal coronary angioplasty)
    Riesgo a largo plazo de mortalidad total, muerte cardiovascular e infarto del miocardio no fatal.
    Estancia hospitalaria y en cuidados intensivos.
    Riesgo de fibrilación auricular significativa; rehospitalización por causas cardiacas, infarto del miocardio no fatal, parada cardiaca, muerte cardiovascular, mortalidad total, y la necesidad de procedimientos de revascularización (bypass coronario y angioplastia coronaria transluminal percutanea)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year the first two
    30 days the last one
    1 año la primeras dos variables
    30 días la ultima
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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
    If are doubts about patient safety, the director of ESEMC may call a committee meeting at any time. The ESEMC make recommendations to the executive committee after considering all available data and any external data relevant to the study. If the recommendation of a premature termination is being considered, the ESEMC invite project officials and researchers to explore all alternatives before making a decision.
    Si aparecieran dudas o temores sobre la seguridad de los pacientes, el director del ESEMC puede convocar una reunión en cualquier momento. El ESEMC hará recomendaciones al comité ejecutivo después de considerar todos los datos disponibles y cualquier dato externo de relevancia para el estudio. Si la recomendación de una finalización prematura esta siendo considerada, el ESEMC invitará a los oficiales e investigadores del proyecto para explorar todas las alternativas antes de tomar una decisión.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days30
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    F.2 Gender
    F.2.1Female No
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state500
    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)
    All patients will be followed by a minimum of one year to determine if they suffered nonfatal myocardial infarction or died. May vary according to each country, can use centralized national databases to complete this monitoring. Study personnel contacted by telephone with the / the patient one year after surgery.
    Todos los pacientes serán seguidos por un mínimo de un año para determinar si sufrieron infarto miocárdico no fatal o fallecieron. Puede variar de acuerdo a cada país, se pueden usar bases de datos nacionales centralizadas para completar este seguimiento. El personal del estudio contactará telefónicamente con el/la paciente un año después de la cirugía.
    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 Decision2006-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-05
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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