Design of Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate vs. acetylsalicylic acid in patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

International Journal of Stroke

Volumn 10, Issue 8, 2015, Pages 1309-1312

  Diener, Hans Christoph ^a   Donald Easton, J ^b   Granger, Christopher B ^c   Cronin, Lisa ^d   Duffy, Christine ^e   Cotton, Daniel ^e   Brueckmann, Martina ^f,g   Sacco, Ralph L ^h  

^a UNIVERSITY HOSPITAL ESSEN   (Germany)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c DUKE UNIVERSITY MEDICAL CENTER   (United States)

^d BOEHRINGER INGELHEIM CANADA LTD   (Canada)

^e BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^f BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^g UNIVERSITY OF HEIDELBERG   (Germany)

^h UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

Author keywords

Acetylsalicylic acid (ASA); Clinical trial; Dabigatran; Minor stroke; Stroke prevention; Transient Ischemic Attack (TIA)

Indexed keywords

ACETYLSALICYLIC ACID; DABIGATRAN ETEXILATE; RIVAROXABAN; ANTITHROMBIN; DABIGATRAN; FIBRINOLYTIC AGENT;

ARTICLE; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CEREBROVASCULAR ACCIDENT; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DEATH; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; HEART INFARCTION; HUMAN; METHODOLOGY; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RANKIN SCALE; RECURRENT DISEASE; RISK REDUCTION; TREATMENT DURATION; TREATMENT OUTCOME; CLINICAL TRIAL; COMPARATIVE STUDY; INTRACRANIAL EMBOLISM; ORAL DRUG ADMINISTRATION; PROSPECTIVE STUDY; SECONDARY PREVENTION; STROKE;

ADMINISTRATION, ORAL; ANTITHROMBINS; ASPIRIN; DABIGATRAN; DOUBLE-BLIND METHOD; FIBRINOLYTIC AGENTS; HUMANS; INTRACRANIAL EMBOLISM; PROSPECTIVE STUDIES; RESEARCH DESIGN; SECONDARY PREVENTION; STROKE;

EID: 84954393666     PISSN: 17474930     EISSN: 17474949     Source Type: Journal    
DOI: 10.1111/ijs.12630     Document Type: Article

References (18)

1. Adams HP, Jr. Bendixen BH, Kappelle LJ,. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10 172 in Acute Stroke Treatment. Stroke 1993; 24:35-41.
2. Fonseca AC, Ferro JM,. Cryptogenic stroke. Eur J Neurol 2015; 22:618-23.
3. Ntaios G, Papavasileiou V, Milionis H,. Embolic strokes of undetermined source in the Athens Stroke Registry: a descriptive analysis. Stroke 2015; 46:176-81.
4. Sacco RL, Ellenberg JH, Mohr JP,. Infarcts of undetermined cause: the NINCDS Stroke Data Bank. Ann Neurol 1989; 25:382-90.
5. Hart RG, Pearce LA, Aguilar MI,. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007; 146:857-67.
6. Kernan WN, Ovbiagele B, Black HR,. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2014; 45:2160-236.
7. Hart RG, Diener HC, Coutts SB,. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol 2014; 13:429-38.
8. Sacco RL, Prabhakaran S, Thompson JL,. Comparison of warfarin versus aspirin for the prevention of recurrent stroke or death: subgroup analyses from the Warfarin-Aspirin Recurrent Stroke Study. Cerebrovasc Dis 2006; 22:4-12.
9. Ruff CT, Giugliano RP, Braunwald E,. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet 2014; 383:955-62.
10. Connolly SJ, Ezekowitz MD, Yusuf S,. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361:1139-51.
11. Healey JS, Connolly SJ, Gold MR,. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med 2012; 366:120-9.
12. Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the S, Standardization Committee of the International Society on T, Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3:692-4.
13. Diener HC, Eikelboom J, Connolly SJ,. Apixaban versus aspirin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a predefined subgroup analysis from AVERROES, a randomised trial. Lancet Neurol 2012; 11:225-31.
14. Favilla CG, Ingala E, Jara J,. Predictors of Finding Occult Atrial Fibrillation After Cryptogenic Stroke. Stroke 2015.
15. Grau AJ, Weimar C, Buggle F,. Risk factors, outcome, and treatment in subtypes of ischemic stroke: the German stroke data bank. Stroke 2001; 32:2559-66.
16. Heidbuchel H, Verhamme P, Alings M,. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013; 15:625-51.
17. Hahn C, Hill MD,. Early anti-coagulation after ischemic stroke due to atrial fibrillation is safe and prevents recurrent stroke. Can J Neurol Sci 2015; 42:92-5.
18. Wardlaw JM, Smith EE, Biessels GJ,. Neuroimaging standards for research into small vessel disease and its contribution to ageing and neurodegeneration. Lancet Neurol 2013; 12:822-38.