Table 2

Ongoing clinical trials on medical management of ICH

Trial name/identifier	Period	Centres	Study phase	Mechanism	Inclusion	Intervention	Primary outcome
SPOTLIGHT NCT01359202	2011–2017	15 centres Canada	Phase II	Haemostatic therapy	N=110 ICH <6 hours onset Spot-sign+	Single injection of rFVIIa 80 µg/kg or placebo	ICH expansion at 24 hours
STOP-IT NCT00810888	2010–2016	13 centres 2 countries	Phase II	Haemostatic therapy	N=184 ICH <5 hours onset Spot-sign+	Single injection of rFVIIa 80 µg/kg or placebo	ICH expansion at 24 hours
NCT00699621	2009–2016	3 centres Finland	Phase II	Haemostatic therapy	N=100 ICH <6 hours onset Antiplatelet use	Platelet transfusion or no therapy	ICH expansion at 24 hours
STOP-AUST NCT01702636	2012–2017	11 centres 2 countries	Phase II	Haemostatic therapy	N=100 ICH<4.5 hours onset Spot-sign+	Intravenous tranexamic acid: 1 g loading dose over 10 min, followed by another 1 g over 8 hours or placebo	ICH expansion at 24 hours
TRAIGE NCT02625948	2015–2018	11 centres China	Phase II	Haemostatic therapy	N=240 ICH <6 hours onset Spot-sign+	intravenous tranexamic acid: 1 g loading dose over 10 min, followed by another 1 g over 8 hours or placebo	ICH expansion at 24 hours
TICH-DOAC	2016–2019	1 centre Switzerland	Phase II	Haemostatic therapy	N=109 ICH <12 hours onset DOAC use	intravenous tranexamic acid: 1 g loading dose over 10 min, followed by another 1 g over 8 hours or placebo	ICH expansion at 24 hours
TICH-2 ISRCTN93732214	2013–2018	95 centres 7 countries	Phase III	Haemostatic therapy	N=2000 ICH <8 hours onset	intravenous tranexamic acid: 1 g loading dose over 10 min, followed by another 1 g over 8 hours or placebo	Ordinal shift on mRS at 90 days
ICH-ADAPT II NCT02281838	2012–2017	2 centres Canada	Phase II	BP control	N=270 ICH <6 hours onset	Aggressive BP therapy (<140 mm Hg) or regular BP therapy (<180 mm Hg)	DWI lesions at 48 hours
HI-DEF NCT01662895	2013–2017	29 centres 2 countries	Phase II	Iron chelation	N=324 ICH <24 hours onset	Intravenous deferoxamine 62 mg/kg/day for 5 days or placebo	mRS at 3 months
iDEF NCT02175225	2014–2018	32 centres 2 countries	Phase II	Iron chelation	N=294 ICH <24 hours onset	Intravenous deferoxamine 32 mg/kg/day for 3 days or placebo	mRS at 3 months
TTM-ICH NCT01607151	2013–2016	1 centre US	Phase II	Cytoprotection	N=50 ICH <18 hours onset	Hypothermia (32–34C) for 72 hours or normothermia	Safety at 15 days
MACH NCT01805895	2013–2017	1 centre US	Phase II	Cytoprotection	N=24 ICH <12 hours onset	Intravenous minocycline 400 mg for 5 days or placebo	mRS at 3 months
ChiCTR-PRC-11001294	2012–2016	1 centre China	Phase IV	Management of complications	N=258 ICH <72 hours onset	Valproate prophylaxis (500 mg daily for 7 days) or placebo	Seizure occurrence at 3 months
PEACH NCT02631759	2016–2019	1 centre France	Phase III	Management of complications	N=104 ICH <24 hours onset	Levetiracetam prophylaxis (500 mg two times per day for 45 days) or placebo	Clinical or electrical seizure (48 hours EEG)
APACHE-AF NCT02565693	2014–2018	15 centres Netherlands	Phase II	Secondary prevention	N=100 ICH 7–90 days VKA use	Apixaban 5 mg two times per day or antiplatelet therapy or no therapy	Combined vascular outcome at 1 year
RESTART ISRCTN71907627	2013–2018	106 centres UK	Phase III	Secondary prevention	N=720 ICH >24 hours onset Antithrombotic use	Antiplatelet drugs or avoid antiplatelet drugs	Recurrent symptomatic ICH at 2 years
TRIDENT NCT02699645	2016–2022	To be determined	Phase IV	Secondary prevention	N=4200 ICH up to 6 months after onset	Fixed low-dose combination BP lowering pill (20 mg telmisartan, 2.5 mg amlodipine and 1.25 mg indapamide) or placebo	Recurrent stroke at 3 years

Trials labelled as scheduled or actively recruiting patients were identified at http://www.clinicaltrials.gov, http://www.isrctn.com and http://www.strokecenter.org/trials/ as of 9 October 2016.
BP, blood pressure; DOAC, direct oral anticoagulant; DWI, diffusion weighted image; ICH, intracerebral haemorrhage; mRS, modified Rankin scale; rFVIIa, activated recombinant factor VII; VKA, vitamin K antagonist.