Design of the trial of Org 10172 in acute stroke treatment (TOAST)

被引:50
作者
Adams, HP [1 ]
Woolson, RF [1 ]
Clarke, WR [1 ]
Davis, PH [1 ]
Bendixen, BH [1 ]
Love, BB [1 ]
Wasek, PA [1 ]
Grimsman, KJ [1 ]
机构
[1] UNIV IOWA,DEPT PREVENT MED,DIV BIOSTAT,COLL MED,IOWA CITY,IA 52242
来源
CONTROLLED CLINICAL TRIALS | 1997年 / 18卷 / 04期
关键词
ischemic stroke; antithrombotic; therapy; acute treatment; clinical trials; design;
D O I
10.1016/S0197-2456(97)00012-3
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
TOAST is a multicenter, randomized, placebo-controlled clinical trial testing the usefulness of a new antithrombotic drug in improving the outcome of persons with acute ischemic stroke. Until recently, no clinical trial testing a treatment for ischemic stroke had demonstrated efficacy in outcome. Design problems of previously conducted trials with inconclusive results may partly explain their failures. During the design of TOAST, the investigators addressed several issues so the trial could test the treatment accurately. We report the strategies used in designing, implementing, and coordinating the trial. (C) Elsevier Science Inc. 1997.
引用
收藏
页码:358 / 377
页数:20
相关论文
共 43 条
  • [1] Adams H P Jr, 1991, J Stroke Cerebrovasc Dis, V1, P134, DOI 10.1016/S1052-3057(10)80005-9
  • [2] GUIDELINES FOR THE MANAGEMENT OF PATIENTS WITH ACUTE ISCHEMIC STROKE - A STATEMENT FOR HEALTH-CARE PROFESSIONALS FROM A SPECIAL WRITING GROUP OF THE STROKE-COUNCIL, AMERICAN-HEART-ASSOCIATION
    ADAMS, HP
    BROTT, TG
    CROWELL, RM
    FURLAN, AJ
    GOMEZ, CR
    GROTTA, J
    HELGASON, CM
    MARLER, JR
    WOOLSON, RF
    ZIVIN, JA
    FEINBERG, W
    MAYBERG, M
    [J]. STROKE, 1994, 25 (09) : 1901 - 1914
  • [3] TRIALS OF TRIALS IN ACUTE ISCHEMIC STROKE - THE HUMANA LECTURE
    ADAMS, HP
    [J]. STROKE, 1993, 24 (09) : 1410 - 1415
  • [4] CLASSIFICATION OF SUBTYPE OF ACUTE ISCHEMIC STROKE - DEFINITIONS FOR USE IN A MULTICENTER CLINICAL-TRIAL
    ADAMS, HP
    BENDIXEN, BH
    KAPPELLE, LJ
    BILLER, J
    LOVE, BB
    GORDON, DL
    MARSH, EE
    KASE, CS
    WOLF, PA
    BABIKIAN, VL
    LICATAGEHR, EE
    ALLEN, N
    BRASS, LM
    FAYAD, PB
    PAVALKIS, FJ
    WEINBERGER, JM
    TUHRIM, S
    RUDOLPH, SH
    HOROWITZ, DR
    BITTON, A
    MOHR, JP
    SACCO, RL
    CLAVIJO, M
    ROSENBAUM, DM
    SPARR, SA
    KATZ, P
    KLONOWSKI, E
    CULEBRAS, A
    CAREY, G
    MARTIR, NI
    FICARRA, C
    HOGAN, EL
    CARTER, T
    GURECKI, P
    MUNTZ, BK
    RAMIREZLASSEPAS, M
    TULLOCH, JW
    QUINONES, MR
    MENDEZ, M
    ZHANG, SM
    ALA, T
    JOHNSTON, KC
    ANDERSON, DC
    TARREL, RM
    NANCE, MA
    BUDLIE, SR
    DIERICH, M
    HELGASON, CM
    HIER, DB
    SHAPIRO, RA
    [J]. STROKE, 1993, 24 (01) : 35 - 41
  • [5] ENSURING RELIABILITY OF OUTCOME MEASURES IN MULTICENTER CLINICAL-TRIALS OF TREATMENTS FOR ACUTE ISCHEMIC STROKE - THE PROGRAM DEVELOPED FOR THE TRIAL OF ORG-10172 IN ACUTE STROKE TREATMENT (TOAST)
    ALBANESE, MA
    CLARKE, WR
    ADAMS, HP
    WOOLSON, RF
    BENDIXEN, BH
    DAVIS, PH
    JACOBY, MR
    GOMEZ, FJ
    DYKEN, ME
    UC, EY
    WOJCIESZEK, JM
    KAPPELLE, LJ
    TANNA, AB
    MITCHELL, VL
    GOMEZ, CR
    MALKOFF, MD
    TULYAPRONCHOTE, R
    SAUER, CM
    RIAZ, G
    SCHMIDT, JG
    MALIK, MM
    BANET, GA
    KARANJIA, PN
    MADDEN, KP
    RUGGLES, KH
    MICKEL, SF
    GOTTSCHALK, PG
    HANSOTIA, PL
    SORENSON, RW
    JACOBSON, DM
    HINER, BC
    MANCL, K
    LUKASIK, E
    BRUNO, A
    LAKIND, ED
    JEFFREY, DR
    MLADINICH, EK
    IQBAL, J
    REINERS, M
    BARRETT, DW
    SHIBUYA, D
    WILLIAMS, JK
    RUSSELL, P
    KING, MK
    CHAPIN, JE
    CARTER, S
    JEFFRIES, L
    HIER, DB
    SHAPIRO, RA
    BRINT, SU
    [J]. STROKE, 1994, 25 (09) : 1746 - 1751
  • [6] HOW TWIN-CITIES NEUROLOGISTS TREAT ISCHEMIC STROKE - POLICIES AND TRENDS
    ANDERSON, DC
    [J]. ARCHIVES OF NEUROLOGY, 1993, 50 (10) : 1098 - 1103
  • [7] [Anonymous], 1980, STAT METHODS CANC RE
  • [8] SPONTANEOUS IMPROVEMENT AFTER ACUTE ISCHEMIC STROKE - A PILOT-STUDY
    BILLER, J
    LOVE, BB
    MARSH, EE
    JONES, MP
    KNEPPER, LE
    JIANG, D
    ADAMS, HP
    GORDON, DL
    [J]. STROKE, 1990, 21 (07) : 1008 - 1012
  • [9] A DOSE ESCALATION STUDY OF ORG-10172 (LOW-MOLECULAR WEIGHT HEPARINOID) IN STROKE
    BILLER, J
    MASSEY, EW
    MARLER, JR
    ADAMS, HP
    DAVIS, JN
    BRUNO, A
    HENRIKSEN, RA
    LINHARDT, RJ
    GOLDSTEIN, LB
    ALBERTS, M
    KISKER, CT
    TOFFOL, GJ
    GREENBERG, CS
    BANWART, KJ
    BERTELS, C
    BECK, DW
    WALKER, M
    MAGNANI, HN
    [J]. NEUROLOGY, 1989, 39 (02) : 262 - 265
  • [10] EXTERNAL PNEUMATIC CALF COMPRESSION REDUCES DEEP VENOUS THROMBOSIS IN PATIENTS WITH RUPTURED INTRACRANIAL ANEURYSMS
    BLACK, PM
    CROWELL, RM
    ABBOTT, WM
    [J]. NEUROSURGERY, 1986, 18 (01) : 25 - 28