Research Article

Analysis of the Modified Rankin Scale in Randomised Controlled Trials of Acute Ischaemic Stroke: A Systematic Review

Table 1

Phase III trials in acute ischemic stroke using mRS as primary outcome published between January 2007 and July 2014.

Clinical trial (publ. year)InterventionNumber of pts.Primary outcome
(favourable score)
Method of analysisResult of trial

CATIS (2014)Antihypertensive4,071mRS at 14 d (0–2) test (unadjusted), OR by logistic regressionNeutral

URICO-ICTUS (2014)Uric acid421mRS at 90 d (0-1 (or 2 if premorbid score was 2))Log-binomial regression (adjusted)Neutral

ALIAS Part 2 (2013)Albumin848mRS and NIHSS at 90 d (0-1)GLM with log link (adjusted)Neutral

AXIS-2 (2013)Filgrastim (G-CSF)328mRS at 90 dOrdinary least squaresNeutral

CERE-LYSE-1 (2013)Cerebrolysin + alteplase119mRS at 90 dOrdinal logistic regressionNeutral, trial terminated

CHIMES (Neuroaid) (2013)MLC6011,100mRS at 3 moOrdinal logistic regression (adjusted)Neutral

ECCS-AIS (2013)Edaravone or citicoline71mRS and NIHSS at 3 moANOVA (mean mRS score)Positive for Edaravone

IMS III (2013)Endovascular therapy656mRS at 3 mo (0–2)CMH test (adjusted)Neutral, trial stopped early

Integrated rehab (2013)Integrated rehabilitation69mRS at 90 d (0-1)Dichotomous (unavailable)Neutral

MAC SI (2013)DP-b99446mRS at 90 dCMH test with modified ridit scoresNeutral ()

NBP (2013)dl-3-n-Butylphthalide573mRS and BI at 90 d (0-1) testPositive ()

NEST 1 & 2 pooled (2013)Transcranial laser therapy 780mRS at 90 d (0–2)Logistic regression (adjusted)Positive

SYNTHESIS Expansion (2013)Endovascular therapy362mRS at 3 mo (0-1)Fisher’s exact test, OR by M-H testNeutral

CASTA (2012)Cerebrolysin1,070Global test: mRS, NIHSS, and BI at 90 dGlobal directional test (Wilcoxon-Mann-Whitney test)Neutral

Early aspirin (2012)Aspirin + alteplase642mRS at 3 mo (0–2)Dichotomous (unspecified)Neutral, terminated early, increased risk of SICH

Ginsenoside-Rd (2012)Ginsenoside-rd390mRS, NIHSS, BI at 90 d (0–2)CMH test (adjusted), OR by logistic regressionPositive

Home rehabilitation (2012)Home rehabilitation60mRS, BI, and EQ-5D at 2 yrs (0-1)Dichotomous (unspecified)Positive

ICTUS (2012)Citicoline2,298global test: mRS, NIHSS, BI at 90 dLogistic regression (adjusted)Neutral

IST-3 (2012)rt-PA3,035OHS at 6 mo (0–2)Logistic regression (adjusted)Neutral

Minocycline (2012)Minocycline50mRS, NIHSS, BI at 90 d-test and Mann-Whitney testPositive

Scalp electrical acupuncture (2012)Scalp electrical acupuncture62NIHSS, mRS, BI at postacupuncture Fisher’s exact testNeutral

ALIAS Part 1 (2011)Albumin316Composite mRS and NIHSS at 90 d (0-1)Dichotomous (unspecified)Neutral

Aphasia (2011)Piracetam49mRS, GAT, NIHSS, and BI scores at 24 wks-test and Mann-Whitney testNeutral

CAIST (2011)Cilostazol458mRS at 90 d (0–2)Normal approximation to binomialComparable to aspirin (efficacy and safety)

QASC (2011)Symptom management initiative1,696mRS, BI, SF-36, PSC score at 90 d (0-1)Logistic regression with GEEPositive

SCAST (2011)Candesartan2,029mRS at 6 moOrdinal logistic regressionNegative

SENTIS (2011)NeuroFlo device515Global endpoint: mRS, NIHSS, BI, and GOS at 90 d (0-1)Logistic regression (adjusted)Neutral

t-PA in elderly (2011)t-PA97mRS at discharge (0–2)Dichotomous (unavailable)Neutral

COSSACS (2010)Antihypertensive763mRS at 2 wks (0–2) test (OR by adjusted logistic regression)Neutral, trial stopped early

EARLY (2010)Aspirin + dipyridamole <24 h548mRS at 90 d (0-1)CMH test (adjusted), OR by logistic regressionNeutral

ASP I & II interim (2009)Ancrod508mRS at 90 d (dependent on prestroke score)Logistic regression (adjusted)Neutral

CHHIPS (2009)BP manipulation180mRS at 2 wks (0–3)Logistic regressionNeutral, study underpowered

DIAS-2 (2009)90 & 125 µg/kg desmoteplase193Composite mRS, NIHSS, and BI at 90 dGlobal statistical testNeutral

EDO (2009)Edaravone401mRS at 3 mo (0-1)Dichotomous (unavailable)Neutral

NEST-2 (2009)Transcranial laser therapy 660mRS and NIHSS at 90 d (0–2)Logistic regression (adjusted)Neutral ()

PAIS (2009)Paracetamol 1,400mRS at 3 moSliding dichotomyNeutral

AbESTT-II (2008)Abciximab801mRS at 3 mo Sliding dichotomy (mRS is 0 if NIHSS is 4–7, 0-1 if 8–14, and 0–2 if 15–22)Neutral

ECASS III (2008)Alteplase (rt-PA)821mRS at 90 d (0-1) test (OR and RR)Positive

Ultrasound guided TCCS (2008)Transcranial color-coded sonography37mRS, BI, and death at 90 dMann-Whitney testNeutral mRS, overall benefit of TCCS therapy

MELT (2007)Urokinase114mRS at 90 d (0–2)Fisher’s exact testNeutral, trial stopped early

SAINT II (2007)NXY-0593,306mRS at 90 dCMH test (adjusted)Neutral

Statin withdrawal (2007)Statin withdrawal89mRS at 3 mo (0–2)Logistic regressionNegative

Ordinal analyses. CMH: Cochran-Mantel-Haenszel, GEE: general estimating equation, GLM: generalised linear model, OR: odds ratio, and RR: relative risk.