Table 3.

Stroke incidence by sub-type in randomized trials testing clopidogrel added to aspirin

		Stroke of ischemic + unknown etiology			Intracerebral haemorrhages*
Trial	n	Combination	Aspirin alone	OR (95% CI)	Combination	Aspirin alone	OR (95% CI)
Stable vascular disease trials
ACTIVE A 2009 (4)	7 554	276	394	0·68 (0·58– 0·80)	30	22	1·37 (0·79– 2·38)
CHARISMA 2006 (5)	15 603	171	198	0·86 (0·70– 1·06)	11	15	0·73 (0·34– 1·60)
PROCLAIM 2009 (6)	181	0	0	1·03 (0·02– 53)	0	0	1·03 (0·02– 53)
REAL-LATE/ZEST-LATE 2010 (7)	2 701	NR	NR	–	NR	NR	–
SPS3 2012 (8)	3 020	104	125	0·81 (0·62– 1·06)	15	8	1·87 (0·79– 4·42)
Meta-analysis	26 358	551	717	0·76 (0·67– 0·87)	56	45	1·24 (0·83– 1·84)
Recent vascular event (≤30 days)
CARESS 2005 (9)	107	0	4	0·11 (0·006– 2·16)	0	0	1·10 (0·02– 56)
CLAIR 2010 (10)	100	0	2	0·22 (0·01– 4·63)	0	0	1·13 (0·02– 58)
COMMIT 2005 (11)	45 852	164	194	0·84 (0·68– 1·04)	55	56	0·98 (0·68– 1·42)
CURE 2001 (12)	12 562	68	82	0·83 (0·60– 1·15)	7	5	1·41 (0·45– 4·45)
FASTER 2007 (13)	392	12	21	0·53 (0·25– 1·11)	2*	0	4·95 (0·24– 104)
Meta-analysis	59 013	244	303	0·81 (0·68– 0·96)	64	61	1·04 (0·73– 1·47)
Surgical/periprocedural
CASCADE 2010 (14)	113	NR	NR	–	NR	NR	–
Cassar et al. 2005 (15)	132	2	0	5·00 (0·24– 106)	0	0	0·97 (0·02– 50)
CREDO 2002 (16)	2 116	NR	NR	–	NR	NR	–
Overall results
Meta-analysis (10 trials)	85 503	797	1 020	0·77 (0·70– 0·85)	120	106	1·12 (0·86– 1·46)

Two trials (SPS3 and Active A) reported unknown strokes separately. Unknowns totaled 45 in the combination vs. 52 with aspirin alone. Excluding unknowns, the meta-analysis OR for ischemic stroke was 0·77 (0·70–0·86).

Only one trial (SPS3) reported sub-dural haematomas: combination 7/1517 vs. with aspirin alone 6/1503.

^*Primary intracerebral.

OR, odds ratio; CI, confidence interval; NR, not reported.