A randomised controlled trial of antiplatelet therapy in combination with Rt-PA thrombolysis in ischemic stroke: Rationale and design of the ARTIS-Trial

Trials

Volumn 11, Issue , 2010, Pages

  Zinkstok, S M ^a   Vermeulen, M ^a   Stam, J ^a   de Haan, R J ^a   Roos, Y B ^a  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ALTEPLASE; CARBASALATE CALCIUM; DIPYRIDAMOLE; LYSINE ACETYLSALICYLATE; SIMVASTATIN; ACETYLSALICYLIC ACID; ANTITHROMBOCYTIC AGENT; FIBRINOLYTIC AGENT; RECOMBINANT PROTEIN; TISSUE PLASMINOGEN ACTIVATOR;

ARTICLE; BRAIN ISCHEMIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FIBRINOLYTIC THERAPY; HUMAN; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; DRUG ADMINISTRATION; DRUG COMBINATION; METHODOLOGY; NETHERLANDS; PROSPECTIVE STUDY; STROKE;

ASPIRIN; BRAIN ISCHEMIA; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FIBRINOLYTIC AGENTS; HUMANS; NETHERLANDS; PLATELET AGGREGATION INHIBITORS; PROSPECTIVE STUDIES; RECOMBINANT PROTEINS; RESEARCH DESIGN; STROKE; THROMBOLYTIC THERAPY; TISSUE PLASMINOGEN ACTIVATOR;

EID: 77951993902     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-11-51     Document Type: Article

References (32)

1. Wardlaw JM, Zoppo G, Yamaguchi T, Berge E. Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev 2003, CD000213.
2. Hacke W, Donnan G, Fieschi C, Kaste M, von KR, Broderick JP, Brott T, Frankel M, Grotta JC, Haley EC, Kwiatkowski T, Levine SR, Lewandowski C, Lu M, Lyden P, Marler JR, Patel S, Tilley BC, Albers G, Bluhmki E, Wilhelm M, Hamilton S. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials. Lancet 2004, 363:768-774. 10.1016/S0140-6736(04)15692-4, 15016487.
3. Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von KR, Wahlgren N, Toni D. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med 2008, 359:1317-1329. 10.1056/NEJMoa0804656, 18815396.
4. Molina CA, Montaner J, Abilleira S, Arenillas JF, Ribo M, Huertas R, Romero F, varez-Sabin J. Time course of tissue plasminogen activator-induced recanalization in acute cardioembolic stroke: a case-control study. Stroke 2001, 32:2821-2827. 10.1161/hs1201.99821, 11739980.
5. Rha JH, Saver JL. The impact of recanalization on ischemic stroke outcome: a meta-analysis. Stroke 2007, 38:967-973. 10.1161/01.STR.0000258112.14918.24, 17272772.
6. Alexandrov AV, Grotta JC. Arterial reocclusion in stroke patients treated with intravenous tissue plasminogen activator. Neurology 2002, 59:862-867. 10.1001/archneur.59.5.862, 12297567.
7. Rubiera M, varez-Sabin J, Ribo M, Montaner J, Santamarina E, Arenillas JF, Huertas R, Delgado P, Purroy F, Molina CA. Predictors of early arterial reocclusion after tissue plasminogen activator-induced recanalization in acute ischemic stroke. Stroke 2005, 36:1452-1456. 10.1161/01.STR.0000170711.43405.81, 15947260.
8. Saqqur M, Molina CA, Salam A, Siddiqui M, Ribo M, Uchino K, Calleja S, Garami Z, Khan K, Akhtar N, O'Rourke F, Shuaib A, Demchuk AM, Alexandrov AV. Clinical deterioration after intravenous recombinant tissue plasminogen activator treatment: a multicenter transcranial Doppler study. Stroke 2007, 38:69-74. 10.1161/01.STR.0000251800.01964.f6, 17138949.
9. Fassbender K, Dempfle CE, Mielke O, Schwartz A, Daffertshofer M, Eschenfelder C, Dollman M, Hennerici M. Changes in coagulation and fibrinolysis markers in acute ischemic stroke treated with recombinant tissue plasminogen activator. Stroke 1999, 30:2101-2104.
10. Tanne D, Macko RF, Lin Y, Tilley BC, Levine SR. Hemostatic activation and outcome after recombinant tissue plasminogen activator therapy for acute ischemic stroke. Stroke 2006, 37:1798-1804. 10.1161/01.STR.0000226897.43749.27, 16763191.
11. Zhu Y, Carmeliet P, Fay WP. Plasminogen activator inhibitor-1 is a major determinant of arterial thrombolysis resistance. Circulation 1999, 99:3050-3055.
12. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. ISIS-2 (Second International Study of Infarct Survival)Collaborative Group. Lancet 1988, 2:349-360.
13. Randomised controlled trial of streptokinase, aspirin, and combination of both in treatment of acute ischaemic stroke. Multicentre Acute Stroke Trial--Italy. (MAST-I) Group. Lancet 1995, 346:1509-1514.
14. Cornu C, Boutitie F, Candelise L, Boissel JP, Donnan GA, Hommel M, Jaillard A, Lees KR. Streptokinase in acute ischemic stroke: an individual patient data meta-analysis: The Thrombolysis in Acute Stroke Pooling Project. Stroke 2000, 31:1555-1560.
15. Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med 1995, 333:1581-1587. 10.1056/NEJM199512143332401, 7477192.
16. Adams HP, del ZG, Alberts MJ, Bhatt DL, Brass L, Furlan A, Grubb RL, Higashida RT, Jauch EC, Kidwell C, Lyden PD, Morgenstern LB, Qureshi AI, Rosenwasser RH, Scott PA, Wijdicks EF. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Circulation 2007, 115:e478-e534. 10.1161/CIRCULATIONAHA.107.181486, 17515473.
17. Grotta JC, Welch KM, Fagan SC, Lu M, Frankel MR, Brott T, Levine SR, Lyden PD. Clinical deterioration following improvement in the NINDS rt-PA Stroke Trial. Stroke 2001, 32:661-668.
18. Uyttenboogaart M, Koch MW, Koopman K, Vroomen PC, De KJ, Luijckx GJ. Safety of antiplatelet therapy prior to intravenous thrombolysis in acute ischemic stroke. Arch Neurol 2008, 65:607-611. 10.1001/archneur.65.5.noc70077, 18332238.
19. Rodrigues AM, Mariz JA, Pinho JD, Maré R, Ferreira C, Fontes J. Antiplatelet therapy before endovenous thrombolysis in acute stroke. Cerebrovasc Dis 2009, 27(suppl 6):80.
20. Gurfinkel EP, Altman R, Scazziota A, Heguilen R, Mautner B. Fast platelet suppression by lysine acetylsalicylate in chronic stable coronary patients. Potential clinical impact over regular aspirin for coronary syndromes. Clin Cardiol 2000, 23:697-700. 10.1002/clc.4960230912, 11016021.
21. Cucchiara BL, Jackson B, Weiner M, Messe SR. Usefulness of checking platelet count before thrombolysis in acute ischemic stroke. Stroke 2007, 38:1639-1640. 10.1161/STROKEAHA.106.480889, 17379817.
22. Holman R, Weisscher N, Glas CA, Dijkgraaf MG, Vermeulen M, de Haan RJ, Lindeboom R. The Academic Medical Center Linear Disability Score (ALDS) item bank: item response theory analysis in a mixed patient population. Health Qual Life Outcomes 2005, 3:83. 10.1186/1477-7525-3-83, 1327691, 16381611.
23. Wahlgren N, Ahmed N, Davalos A, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kuelkens S, Larrue V, Lees KR, Roine RO, Soinne L, Toni D, Vanhooren G. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet 2007, 369:275-282. 10.1016/S0140-6736(07)60149-4, 17258667.
24. Sane DC, Stump DC, Topol EJ, Sigmon KN, Clair WK, Kereiakes DJ, George BS, Stoddard MF, Bates ER, Stack RS. Racial differences in responses to thrombolytic therapy with recombinant tissue-type plasminogen activator. Increased fibrin(ogen)olysis in blacks. The Thrombolysis and Angioplasty in Myocardial Infarction Study Group. Circulation 1991, 83:170-175.
25. Taylor HA, Chaitman BR, Rogers WJ, Kern MJ, Terrin ML, Aguirre FV, Sopko G, McMahon R, Ross RN, Bovill EC. Race and prognosis after myocardial infarction. Results of the thrombolysis in myocardial infarction (TIMI) phase II trial. Circulation 1993, 88:1484-1494.
26. Berkowitz SD, Granger CB, Pieper KS, Lee KL, Gore JM, Simoons M, Armstrong PW, Topol EJ, Califf RM. Incidence and predictors of bleeding after contemporary thrombolytic therapy for myocardial infarction. The Global Utilization of Streptokinase and Tissue Plasminogen activator for Occluded coronary arteries (GUSTO) I Investigators. Circulation 1997, 95:2508-2516.
27. Bravo Y, Marti-Fabregas J, Cocho D, Rodriguez-Yanez M, Castellanos M, de la Ossa NP, Roquer J, Obach V, Maestre J, Marti-Vilalta JL. Influence of antiplatelet pre-treatment on the risk of symptomatic intracranial haemorrhage after intravenous thrombolysis. Cerebrovasc Dis 2008, 26:126-133. 10.1159/000139659, 18560215.
28. Schmulling S, Rudolf J, Strotmann-Tack T, Grond M, Schneweis S, Sobesky J, Thiel A, Heiss WD. Acetylsalicylic acid pretreatment, concomitant heparin therapy and the risk of early intracranial hemorrhage following systemic thrombolysis for acute ischemic stroke. Cerebrovasc Dis 2003, 16:183-190. 10.1159/000071114, 12865603.
29. Sobesky J, Frackowiak M, Zaro WO, Hahn M, Moller-Hartmann W, Rudolf J, Neveling M, Grond M, Schmulling S, Jacobs A, Heiss WD. The Cologne stroke experience: safety and outcome in 450 patients treated with intravenous thrombolysis. Cerebrovasc Dis 2007, 24:56-65. 10.1159/000103117, 17519545.
30. Tanne D, Kasner SE, Demchuk AM, Koren-Morag N, Hanson S, Grond M, Levine SR. Markers of increased risk of intracerebral hemorrhage after intravenous recombinant tissue plasminogen activator therapy for acute ischemic stroke in clinical practice: the Multicenter rt-PA Stroke Survey. Circulation 2002, 105:1679-1685. 10.1161/01.CIR.0000012747.53592.6A, 11940547.
31. Wahlgren N, Ahmed N, Eriksson N, Aichner F, Bluhmki E, Davalos A, Erila T, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kohrmann M, Larrue V, Lees KR, Machnig T, Roine RO, Toni D, Vanhooren G. Multivariable analysis of outcome predictors and adjustment of main outcome results to baseline data profile in randomized controlled trials: Safe Implementation of Thrombolysis in Stroke-MOnitoring STudy (SITS-MOST). Stroke 2008, 39:3316-3322. 10.1161/STROKEAHA.107.510768, 18927461.
32. Zinkstok SM, Vermeulen M, Stam J, de Haan RJ, Roos YB. Antiplatelet therapy in combination with rt-PA thrombolysis in ischemic stroke (ARTIS): rationale and design of a randomized controlled trial. Cerebrovasc Dis 2009, 27:79-81.