The early termination of clinical trials: causes, consequences, and control. With special reference to trials in the field of arrhythmias and sudden death. Task Force of the Working Group on Arrhythmias of the European Society of Cardiology.

Abstract:

:The early termination of clinical trials, for either benefit or harm, often generates undue enthusiasm or alarm. The enhanced publicity attending early termination of a trial promotes inappropriate interpretations because of the inherent difficulty of a prompt and comprehensive data review. Furthermore, the process of monitoring the accumulating outcome data for early evidence of treatment benefit or harm is fraught with many statistical and methodological difficulties. This report from a Task Force convened by the Working Group on Arrhythmias of the European Society of Cardiology incorporates first, a series of trials terminated appropriately or inappropriately for benefit or harm and used as examples to illustrate the importance of suitable trial design and of proper stopping rules; second, a description of the committee structure of a clinical trial; third, an analysis of the general design issues; fourth, a review of the main issues in interim analysis with special reference to main strategies for reducing the rate of false-positive claims that could result from early trial termination; and finally, a series of specific recommendations concerning the design, structure, analysis, interpretation, and presentation of a clinical trial.

journal_name

Eur Heart J

journal_title

European heart journal

authors

subject

Has Abstract

pub_date

1994-06-01 00:00:00

pages

721-38

issue

6

eissn

0195-668X

issn

1522-9645

journal_volume

15

pub_type

杂志文章
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    abstract:: ...

    journal_title:European heart journal

    pub_type: 评论,杂志文章

    doi:10.1093/eurheartj/ehz081

    authors: Libby P

    更新日期:2019-03-14 00:00:00

  • The diagnostic accuracy of 256-row computed tomographic angiography compared with invasive coronary angiography in patients with suspected coronary artery disease.

    abstract:AIMS:To assess the diagnostic accuracy of 256-row computed tomographic angiography (CTA) in patients with suspected coronary artery disease (CAD). Non-invasive imaging of the coronary artery by CTA has increasingly been used in recent years. The accuracy of 256-row CTA has not yet been studied. We sought to assess the ...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/ehq072

    authors: Chao SP,Law WY,Kuo CJ,Hung HF,Cheng JJ,Lo HM,Shyu KG

    更新日期:2010-08-01 00:00:00

  • Troponin I and cardiovascular risk prediction in the general population: the BiomarCaRE consortium.

    abstract:AIMS:Our aims were to evaluate the distribution of troponin I concentrations in population cohorts across Europe, to characterize the association with cardiovascular outcomes, to determine the predictive value beyond the variables used in the ESC SCORE, to test a potentially clinically relevant cut-off value, and to ev...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/ehw172

    authors: Blankenberg S,Salomaa V,Makarova N,Ojeda F,Wild P,Lackner KJ,Jørgensen T,Thorand B,Peters A,Nauck M,Petersmann A,Vartiainen E,Veronesi G,Brambilla P,Costanzo S,Iacoviello L,Linden G,Yarnell J,Patterson CC,Everett BM

    更新日期:2016-08-07 00:00:00

  • Clinical relevance of vegetation localization by transoesophageal echocardiography in infective endocarditis.

    abstract::Infective endocarditis is associated with significant morbidity and mortality, with valvular destruction and congestive heart failure being more common in patients with echocardiographically discernible vegetations. The transoesophageal approach affords consistently high quality images with excellent structural resolu...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/oxfordjournals.eurheartj.a060195

    authors: Rohmann S,Erbel R,Görge G,Makowski T,Mohr-Kahaly S,Nixdorff U,Drexler M,Meyer J

    更新日期:1992-04-01 00:00:00

  • Determinants of pulse wave velocity in healthy people and in the presence of cardiovascular risk factors: 'establishing normal and reference values'.

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    journal_title:European heart journal

    pub_type: 杂志文章,多中心研究

    doi:10.1093/eurheartj/ehq165

    authors: Reference Values for Arterial Stiffness' Collaboration.

    更新日期:2010-10-01 00:00:00

  • Sex associations and computed tomography coronary angiography-guided management in patients with stable chest pain.

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    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/ehz903

    authors: Mangion K,Adamson PD,Williams MC,Hunter A,Pawade T,Shah ASV,Lewis S,Boon NA,Flather M,Forbes J,McLean S,Roditi G,van Beek EJR,Timmis AD,Newby DE,McAllister DA,Berry C

    更新日期:2020-04-01 00:00:00

  • Picotamide, a combined inhibitor of thromboxane A2 synthase and receptor, reduces 2-year mortality in diabetics with peripheral arterial disease: the DAVID study.

    abstract:AIMS:Patients with diabetes are at excessive risk of mortality and cardiovascular morbidity. Previous studies suggest that aspirin may be less effective in diabetic patients. In this multi-centre, randomized, double blind trial picotamide, a dual inhibitor of thromboxane A2 synthase and receptor, was compared with aspi...

    journal_title:European heart journal

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1016/j.ehj.2004.07.013

    authors: Neri Serneri GG,Coccheri S,Marubini E,Violi F,Drug Evaluation in Atherosclerotic Vascular Disease in Diabetics (DAVID) Study Group.

    更新日期:2004-10-01 00:00:00

  • Acute vascular toxicity after combination chemotherapy with cisplatin, vinblastine, and bleomycin for testicular cancer.

    abstract::Twenty-one consecutive patients with testicular cancer treated with bleomycin, vinblastine, and cisplatin (PVB) were evaluated for acute vascular ischaemic events during chemotherapy. Angina pectoris occurred in 8/21 (38%) patients, a median 5.6 weeks after initiation of chemotherapy and persisted for 2-7 days. Raynau...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/oxfordjournals.eurheartj.a062542

    authors: Stefenelli T,Kuzmits R,Ulrich W,Glogar D

    更新日期:1988-05-01 00:00:00

  • Management and outcome of patients with established coronary artery disease: the Euro Heart Survey on coronary revascularization.

    abstract:AIMS:The purpose of the Euro Heart Survey Programme of the European Society of Cardiology is to evaluate to which extent clinical practice endorses existing guidelines as well as to identify differences in population profiles, patient management, and outcome across Europe. The current survey focuses on the invasive dia...

    journal_title:European heart journal

    pub_type: 杂志文章,多中心研究

    doi:10.1093/eurheartj/ehi238

    authors: Lenzen MJ,Boersma E,Bertrand ME,Maier W,Moris C,Piscione F,Sechtem U,Stahle E,Widimsky P,de Jaegere P,Scholte op Reimer WJ,Mercado N,Wijns W,European Society of Cardiology.

    更新日期:2005-06-01 00:00:00

  • Contractile function of right ventricular papillary muscle after left ventricular infarction in rats: effects of early and late inhibition of angiotensin converting enzyme.

    abstract::Alterations in the right ventricular function may or may not contribute to progressive cardiac dysfunction after left ventricular infarction. Ligation of the left coronary artery (LCAL) was lethal within 24 h for 25% of 100 rats, whereas none of 21 sham-operated rats died. No rats died during the following 4 weeks, af...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/14.11.1554

    authors: Christiansen EH,Tian R,Böttcher M,Andreasen F

    更新日期:1993-11-01 00:00:00

  • Efficacy and safety of reduced-dose non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: a meta-analysis of randomized controlled trials.

    abstract:AIMS:Non-vitamin K antagonist oral anticoagulants (NOACs) require dose reductions according to patient or clinical factors for patients with atrial fibrillation (AF). In this meta-analysis, we aimed to assess outcomes with reduced-dose NOACs when given as pre-specified in pivotal trials. METHODS AND RESULTS:Aggregated...

    journal_title:European heart journal

    pub_type: 杂志文章,meta分析

    doi:10.1093/eurheartj/ehy802

    authors: Wang KL,Lopes RD,Patel MR,Büller HR,Tan DS,Chiang CE,Giugliano RP

    更新日期:2019-05-14 00:00:00

  • Use of abciximab in interventional cardiology.

    abstract::The advent of platelet membrane glycoprotein (GP) IIb/IIIa inhibitors has changed the landscape of interventional cardiology. Given the commercial availability of abciximab and expected regulatory approvals for other receptor blockers, defining appropriate use of these agents in the interventional setting is mandated....

    journal_title:European heart journal

    pub_type: 杂志文章,评审

    doi:

    authors: Chronos N,Vahanian A,Betriu A,Emanuelsson H,Goldberg S,Gulba D,van Hout BA

    更新日期:1998-04-01 00:00:00

  • Effect of flecainide on left ventricular ejection fraction.

    abstract::Antiarrhythmic agents may depress cardiac contractility and worsen heart failure. Flecainide is an effective antiarrhythmic drug, but when administered orally in patients with left ventricular (LV) dysfunction, its effect on LV function is unknown. To assess the effects of flecainide on cardiac function, LV ejection f...

    journal_title:European heart journal

    pub_type: 临床试验,杂志文章

    doi:10.1093/eurheartj/8.7.754

    authors: Brembilla-Perrot B,Amor M,Auque F,Isaaz K,Terrier de la Chaise A,Bertrand A,Cherrier F,Pernot C

    更新日期:1987-07-01 00:00:00

  • Physiological cost of vocational activities after myocardial infarction.

    abstract::Oxygen consumption was measured during 30 min of work in 16 patients, after a myocardial infarction (anterior or posterior), and compared with 16 normal subjects, of the same age, involved in the same activities, in a steel factory. The VO2 at work of the patients was a little lower than in normals. The mean heart rat...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/9.suppl_l.54

    authors: Denolin H,Riviere A

    更新日期:1988-11-01 00:00:00

  • Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry.

    abstract:AIMS:The totally subcutaneous implantable-defibrillator (S-ICD) is a new alternative to the conventional transvenous ICD system to minimize intravascular lead complications. There are limited data describing the long-term performance of the S-ICD. This paper presents the first large international patient population col...

    journal_title:European heart journal

    pub_type: 杂志文章,多中心研究

    doi:10.1093/eurheartj/ehu112

    authors: Lambiase PD,Barr C,Theuns DA,Knops R,Neuzil P,Johansen JB,Hood M,Pedersen S,Kääb S,Murgatroyd F,Reeve HL,Carter N,Boersma L,EFFORTLESS Investigators.

    更新日期:2014-07-01 00:00:00

  • Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating.

    abstract:AIMS:Drug-eluting stents (DES) represent a major advance in interventional cardiology. Along with the success shown, current DES also present limitations related to the presence of polymer-coating, fixed drug, and dose used. With the ISAR (Individualized Drug-Eluting Stent System to Abrogate Restenosis) project, a DES ...

    journal_title:European heart journal

    pub_type: 临床试验,杂志文章

    doi:10.1093/eurheartj/ehi405

    authors: Hausleiter J,Kastrati A,Wessely R,Dibra A,Mehilli J,Schratzenstaller T,Graf I,Renke-Gluszko M,Behnisch B,Dirschinger J,Wintermantel E,Schömig A,investigators of the individualizable durg-eluting Stent System to Abrogate Restenosi

    更新日期:2005-08-01 00:00:00

  • High-sensitivity cardiac troponin assays for cardiovascular risk stratification in the general population.

    abstract::Cardiac troponins (cTns) I and T have long been the most successful cardiac-specific circulating biomarkers in cardiovascular (CV) medicine, having changed dramatically the diagnosis of acute myocardial infarction, while being independent predictors of outcome in several cardiac conditions and non-cardiac conditions. ...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/ehaa083

    authors: Farmakis D,Mueller C,Apple FS

    更新日期:2020-11-01 00:00:00

  • Effect of alirocumab on major adverse cardiovascular events according to renal function in patients with a recent acute coronary syndrome: prespecified analysis from the ODYSSEY OUTCOMES randomized clinical trial.

    abstract:AIMS:Statins reduce cardiovascular risk in patients with acute coronary syndrome (ACS) and normal-to-moderately impaired renal function. It is not known whether proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors provide similar benefit across a range of renal function. We determined whether effects of the...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/ehaa498

    authors: Tuñón J,Steg PG,Bhatt DL,Bittner VA,Díaz R,Goodman SG,Jukema JW,Kim YU,Li QH,Mueller C,Parkhomenko A,Pordy R,Sritara P,Szarek M,White HD,Zeiher AM,Schwartz GG,ODYSSEY OUTCOMES Investigators.

    更新日期:2020-11-07 00:00:00

  • Atherogenic risk reduction in patients with dyslipidaemia. comparison between bezafibrate and lovastatin.

    abstract:OBJECTIVE:To examine the atherogenic risk-reducing effect of bezafibrate and lovastatin. DESIGN, SETTING, PATIENTS, INTERVENTIONS:Double-blind, randomized clinical trial of male and female patients with moderate hypercholesterolaemia with or without hypertriglyceridaemia. Two months dietary treatment followed by 400 m...

    journal_title:European heart journal

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1093/oxfordjournals.eurheartj.a060769

    authors: Sinzinger H,Pirich C,Kondor P,Etti H

    更新日期:1995-11-01 00:00:00

  • Left ventricular outflow tract obstruction and sudden death risk in patients with hypertrophic cardiomyopathy.

    abstract:AIMS:Left ventricular outflow tract obstruction (LVOTO) is associated with reduced survival in patients with hypertrophic cardiomyopathy (HCM). The influence of LVOTO on survival from SD in relation to other recognized clinical risk markers is unknown. METHODS AND RESULTS:A total of 917 patients with HCM (554 males, 4...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/ehl041

    authors: Elliott PM,Gimeno JR,Tomé MT,Shah J,Ward D,Thaman R,Mogensen J,McKenna WJ

    更新日期:2006-08-01 00:00:00

  • Adipose dysplasia of the right ventricle: is endomyocardial biopsy useful?

    abstract::Right ventricular dysplasia (RVD) is a cardiac anomaly characterized by replacement of right ventricular myocardium by adipose and fibrous tissue that was first described at autopsy, and is now being recognized pre-mortem. Sudden death and ventricular arrhythmias are the most common clinical manifestation of the condi...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/10.suppl_d.84

    authors: Strain J

    更新日期:1989-09-01 00:00:00

  • Effects of multiple ischaemic events on human myocardium--an ultrastructural study.

    abstract::Chronically ischaemic myocardium from patients with coronary heart disease was investigated by light and electron microscopy using tissue biopsies taken during cardiac surgery. Light microscopy showed a significantly increased amount of fibrotic material, cell size was variable. By electron microscopy, the most obviou...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/9.suppl_a.141

    authors: Schaper J

    更新日期:1988-01-01 00:00:00

  • Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial.

    abstract:AIM:The present study aimed to assess the benefits of two-stent techniques for patients with DEFINITION criteria-defined complex coronary bifurcation lesions. METHODS AND RESULTS:In total, 653 patients with complex bifurcation lesions at 49 international centres were randomly assigned to undergo the systematic two-ste...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/ehaa543

    authors: Zhang JJ,Ye F,Xu K,Kan J,Tao L,Santoso T,Munawar M,Tresukosol D,Li L,Sheiban I,Li F,Tian NL,Rodríguez AE,Paiboon C,Lavarra F,Lu S,Vichairuangthum K,Zeng H,Chen L,Zhang R,Ding S,Gao F,Jin Z,Hong L,Ma L,We

    更新日期:2020-07-14 00:00:00

  • Peak oxygen uptake is not determined by cardiac noradrenaline spillover in heart failure.

    abstract:AIMS:We recently found that resting muscle sympathetic nerve activity is inversely related to peak oxygen uptake (VO(2) peak) in patients with heart failure, suggesting a peripheral neurogenic limit to exercise in heart failure. No such relationship was observed in healthy controls. To determine whether this observatio...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1053/euhj.2001.2942

    authors: Notarius CF,Azevedo ER,Parker JD,Floras JS

    更新日期:2002-05-01 00:00:00

  • Failure of provision of antibiotic prophylaxis for 'at risk' cardiac patients: impetus for improvement required from cardiologists.

    abstract::We conducted a survey by questionnaire to assess whether patients 'at risk' from infective endocarditis are aware of the need for good dental hygiene and antibiotic prophylaxis, and receive appropriate advice or treatment. Of 189 patients surveyed, half had told a dentist about their heart, 8% were aware of a dental p...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/14.6.812

    authors: Forbat LN,Skehan JD

    更新日期:1993-06-01 00:00:00

  • Effect of clopidogrel on 1-year mortality in hospital survivors of acute ST-segment elevation myocardial infarction in clinical practice.

    abstract:AIMS:We sought to assess the effect of clopidogrel on clinical events 1 year after discharge in survivors of ST-elevation myocardial infarction (STEMI) in clinical practice. METHODS AND RESULTS:We analysed data of consecutive survivors of acute STEMI and either concomitant therapy with aspirin or aspirin plus clopidog...

    journal_title:European heart journal

    pub_type: 杂志文章,多中心研究

    doi:10.1093/eurheartj/ehl317

    authors: Zeymer U,Gitt AK,Jünger C,Heer T,Wienbergen H,Koeth O,Bauer T,Mark B,Zahn R,Gottwik M,Senges J,Acute COronary Syndromes (ACOS) registry investigators.

    更新日期:2006-11-01 00:00:00

  • Major differences among the three classes of calcium antagonists.

    abstract::The safety of calcium antagonists has recently become a controversial issue among cardiologists. Thus, the role of calcium antagonists in the treatment of myocardial infarction and in secondary cardiovascular prevention is under review. As a consequence, the concept that the words 'calcium antagonists' comprise variou...

    journal_title:European heart journal

    pub_type: 杂志文章,评审

    doi:10.1093/eurheartj/18.suppl_a.56

    authors: Ferrari R

    更新日期:1997-01-01 00:00:00

  • Inhibition of mitochondrial permeability transition to prevent the post-cardiac arrest syndrome: a pre-clinical study.

    abstract:AIMS:Resuscitated cardiac arrest (CA), leading to harmful cardiovascular dysfunction and multiple organ failure, includes a whole-body hypoxia-reoxygenation phenomenon. Opening of the mitochondrial permeability transition pore (mPTP) appears to be a pivotal event in ischaemia-reperfusion injury. We hypothesized that ph...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/ehq112

    authors: Cour M,Loufouat J,Paillard M,Augeul L,Goudable J,Ovize M,Argaud L

    更新日期:2011-01-01 00:00:00

  • BDNFVal66met polymorphism: a potential bridge between depression and thrombosis.

    abstract:Aims:Epidemiological studies strongly suggest a link between stress, depression, and cardiovascular diseases (CVDs); the mechanistic correlation, however, is poorly understood. A single-nucleotide polymorphism in the BDNF gene (BDNFVal66Met), associated with depression and anxiety, has been proposed as a genetic risk f...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/ehv655

    authors: Amadio P,Colombo GI,Tarantino E,Gianellini S,Ieraci A,Brioschi M,Banfi C,Werba JP,Parolari A,Lee FS,Tremoli E,Barbieri SS

    更新日期:2017-05-07 00:00:00

  • Successful catheter ablation by radiofrequency energy of posteroseptal accessory pathway in a patient with drug refractory Wolff-Parkinson-White syndrome.

    abstract::A 45-year-old patient with the Wolff-Parkinson-White syndrome suffering from recurrent intractable reciprocating atrioventricular tachycardia (RAVT) is reported. He used amiodarone, sotalol, quinidine, propafenone and flecainide unsuccessfully. An electrophysiological study (EPS) performed with four catheters localize...

    journal_title:European heart journal

    pub_type: 杂志文章

    doi:10.1093/eurheartj/12.12.1321

    authors: Delise P,Bonso A,Raviele A,Cazzin R,Di Pede F,Piccolo E

    更新日期:1991-12-01 00:00:00