Design of a placebo-controlled clinical trial of long-acting diltiazem and aspirin versus aspirin alone in patients receiving thrombolysis with a first acute myocardial infarction

Boden, William E.; Scheldewaert, Rudy; Walters, Ewan G.; Whitehead, Anne; Coltart, D J; Santoni, Jean-Philippe; Belgrave, G P; Starkey, Ian R.

doi:10.1016/s0002-9149(99)80742-5

Cited by 24 publications

(5 citation statements)

References 16 publications

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“…Evaluating Prognosis Post Thrombolysis) (diltiazem) will test the hypothesis that use of sustained-release diltiazem in patients receiving thrombolytic therapy for a first MI will decrease mortality, reinfarction, and angina (547).…”

Section: The Intercept Trial (Incomplete Infarction Trial Of Europeanmentioning

confidence: 99%

ACC/AHA Guidelines for the Management of Patients With Acute Myocardial Infarction:Executive Summary

et al. 1996

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It is the aim of these revised guidelines to reflect what the committee has identified as the most important changes to be made in thinking about patients with AMI. Many therapies and procedures in current use are not based on sound scientific evidence. The committee proposes the abandonment of such therapies and procedures that can be identified with confidence. On the other hand, new information suggests that a practical division of all patients with AMI is to classify them as those with ST-segment elevation and those without it. Evidence now shows a distinction in pathoanatomy between the two that demands different therapeutic approaches. Ample evidence exists that persons with suspected MI and ST-segment elevation or bundlebranch block (BBB) should undergo immediate reperfusion, and those without these findings should not. Committee members were selected from cardiovascular specialists with broad geographical representation and combined involvement in academic medicine and primary practice. The Committee on Management of Acute Myocardial Infarction was also broadened by members of the American Academy of Family Physicians, the American College of Emergency Physicians, the AHA Council on Cardiovascular Nursing, and the American Association of Critical-Care Nurses.

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Section: The Intercept Trial (Incomplete Infarction Trial Of Europeanmentioning

confidence: 99%

ACC/AHA Guidelines for the Management of Patients With Acute Myocardial Infarction:Executive Summary

et al. 1996

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“…Jennison and Turnbull [178] provide a comprehensive guide to group sequential designs and their application. Whitehead [179] describes the implementation of group sequential methods using SAS; in addition, the gsDesign [180] and optGS [181] Example The INTERCEPT trial [182,183] was a randomised, double-blind trial in patients with acute myocardial infarction. The trial used a group sequential design to achieve 80% power to detect a 33% between-group difference in cumulative first event rate of cardiac death, non-fatal reinfarction, or refractory ischaemia.…”

Section: Group Sequential Designsmentioning

confidence: 99%

Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs

Burnett

Mozgunov

Pallmann

et al. 2020

BMC Med

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Adaptive designs for clinical trials permit alterations to a study in response to accumulating data in order to make trials more flexible, ethical, and efficient. These benefits are achieved while preserving the integrity and validity of the trial, through the pre-specification and proper adjustment for the possible alterations during the course of the trial. Despite much research in the statistical literature highlighting the potential advantages of adaptive designs over traditional fixed designs, the uptake of such methods in clinical research has been slow. One major reason for this is that different adaptations to trial designs, as well as their advantages and limitations, remain unfamiliar to large parts of the clinical community. The aim of this paper is to clarify where adaptive designs can be used to address specific questions of scientific interest; we introduce the main features of adaptive designs and commonly used terminology, highlighting their utility and pitfalls, and illustrate their use through case studies of adaptive trials ranging from early-phase dose escalation to confirmatory phase III studies.

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“…Example: The INTERCEPT trial [182,183] was a randomised, double blind trial in patients with acute myocardial infarction. The trial used a group sequential design to achieve 80% power to detect a 33% between-group difference in cumulative first event rate of cardiac death, non-fatal reinfarction, or refractory ischaemia.…”

Section: Group Sequential Designsmentioning

confidence: 99%

Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs

Burnett¹,

Mozgunov²,

Pallmann³

et al. 2020

Preprint

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Adaptive designs for clinical trials permit alterations to a study in response to accumulating data in order to make trials more flexible, ethical and efficient. These benefits are achieved while preserving the integrity and validity of the trial, through the pre-specification and proper adjustment for the possible alterations during the course of the trial. Despite much research in the statistical literature highlighting the potential advantages of adaptive designs over traditional fixed designs, the uptake of such methods in clinical research has been slow. One major reason for this is that different adaptations to trial designs, as well as their advantages and limitations, remain unfamiliar to large parts of the clinical community. The aim of this paper is to clarify where adaptive designs can be used to address specific questions of scientific interest; we introduce the main features of adaptive designs and commonly used terminology, highlighting their utility and pitfalls, and illustrate their use through case studies of adaptive trials ranging from early-phase dose escalation to confirmatory Phase III studies.

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Design of a placebo-controlled clinical trial of long-acting diltiazem and aspirin versus aspirin alone in patients receiving thrombolysis with a first acute myocardial infarction

Cited by 24 publications

References 16 publications

ACC/AHA Guidelines for the Management of Patients With Acute Myocardial Infarction:Executive Summary

ACC/AHA Guidelines for the Management of Patients With Acute Myocardial Infarction:Executive Summary

Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs

Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs

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