432: Expediting MRI-based proof of concept stroke trials using an earlier primary endpoint

Thrombolysis for acute ischaemic stroke

“…The final outcome assessment was at: about one month after the stroke (Abe 1981; Atarashi 1985; JTSG 1993; Mori 1992; Morris 1995; Ohtomo 1985);three months after the stroke (ASK 1996; ATLANTIS A 2000; ATLANTIS B 1999; Chen 2000; DEDAS 2006; DIAS 2005; DIAS 2 2008; ECASS 1995; ECASS II 1998; ECASS 3 2008; EPITHET 2008; Haley 1993; MELT 2007; NINDS 1995; PROACT 1998; PROACT 2 1999; Wang 2003); andsix months after the stroke (AUST 2005; IST3 2012; MAST-E 1996; MAST-I 1995). …”

“…three months after the stroke (ASK 1996; ATLANTIS A 2000; ATLANTIS B 1999; Chen 2000; DEDAS 2006; DIAS 2005; DIAS 2 2008; ECASS 1995; ECASS II 1998; ECASS 3 2008; EPITHET 2008; Haley 1993; MELT 2007; NINDS 1995; PROACT 1998; PROACT 2 1999; Wang 2003); and…”

“…In another study (IST3 2012) the six-month follow-up was blinded and performed either by postal mail or telephone by a trained observer blind to the treatment allocation. Seven studies (ASK 1996; DEDAS 2006; DIAS 2005; DIAS 2 2008; EPITHET 2008;MAST-E 1996;Wang 2003) did not specify who performed the follow-up or that they should not have been involved in the trial treatment administration or participant care in the first 24 hours. In five studies (ATLANTIS A 2000; ATLANTIS B 1999; Chen 2000; ECASS 3 2008; NINDS 1995), follow-up at all stages was done by a doctor who had not been involved in the randomisation or care of the participant in the first 24 hours.…”